Meditech Pharma Jobs in Usa

Technical Writer (Pharma) Job Summary:

A leading global contract development and manufacturing organization (CDMO) in St. Louis, MO is seeking a Technical Writer. This is a contract-to-hire role and it will require you to work onsite five days a week. As a Technical Writer, you will author new and revise existing documents to ensure content accuracy and conformance to established standards. The scope includes, but is not limited to, developing and/or revising standard operating procedures, batch records, forms, and training documents to support aseptic operations.

Technical Writer (Pharma) Responsibilities:

• Write standard operating procedures with appropriate details that are easily understood, readily usable for consistency in training, and conform to company policies and government regulations.
• Develop procedural documents using human performance and technical writing tools that enable right-first-time document execution efficiencies. Regularly monitors department documentation metrics for the purpose of making document improvements to minimize the potential for data entry errors on executable forms.
• Review and analyze new and existing procedures for concurrence with correct department methods through direct observation of aseptic manufacturing processes and interviews with subject matter experts.
• Manage department document projects; ensure project deliverables are completed per the project timeline.
• Draft new and revised SOPs, Batch Records, Forms, and OJT skill assessment documents.
• Leads continuous improvement efforts related to GMP documentation.
• Interact with internal departments to develop new and revised documents. Directly interact with the sites' Manufacturing, Quality, Validation, Regulatory and EHS Departments to ensure document revisions are accurate, executable and comprehendible.
• Track and report document status for key projects.

Technical Writer (Pharma) Qualifications:

• Associates degree in life science, education/training, or other equivalent related discipline.
• 1-2 years pharmaceutical experience.
• Excellent project management and organizational skills including the ability to independently understand, follow, and implement complex instructions and follow assignments through to completion.
• Knowledge of Quality Systems as it relates to GMP documentation requirements.
• Strong technical writing ability with experience writing instructional documents.
• Advanced computer skills that include MS Word, Visio, PowerPoint, Excel, Adobe Acrobat. Ability to work in and create Microsoft Word Templates. Ability to create and revise complex Word documents that include formatting pictures, tables, shapes, and embedded macros.
• Project management and organizational skills.
• Excellent verbal and written communication skills.
• Interpersonal and communication skills required to build and maintain working partnerships with all levels of the organization.

Our client – a global and growing BioPharma CDMO company needs an Engineering Line Lead with Pharmaceutical Industry experienceat their expanding plant in WA state, Excellent total comp. up to $180K+ with excellent Benefits + Relocation Bonus. Client will sponsor for H1B Visa transfer.

Job Posting # 2705R

Job Title: Engineering Team Lead Overnight Travel: 10%

Location: Spokane, WA

Relocation: YES – Theclient offers a lumpsum bonus for relo assistance.

Compensation:Salary range $120K - $165K+ Annual Bonus (10 %)

Full Benefits: Medical, Vision, Dental, 15 days’ vacation/Sick time, 10 - Holidays, 401k (match up to 4%).

Company Info:

Our client is a growing CDMO company in the Pharmaceutical Industry. They are a part of a global parent company with sites in many countries with around 1,300 people at this site in Spokane, WA.

This is an integrated contract development and manufacturing organization (CDMO) offering specialized Aseptic Sterile manufacturing, filling and lyophilization of drug products in Vials.

Group Info: Be part of the Plant Engineering group of around 60 technical people. This role will have 3 people reporting under this person and handle all technical aspects for this new line 3 (note 1 + 2 below)

This role will report to the Engineering Manager.

Note 1: The company recently completed installation of their 3rd state-of-the-art Sterile Liquid compounding & Vial Filling line and are expanding again with a 4th line at this growing plant site.

Note 2: The primary focus will be the technical and project engineering aspects of a complete filling line.

Note 3: Client willsupport transfer of existing H1B Visa for this permanent direct hire role, but will not sponsor for a new H1B visa.

Job Summary:

The Engineering Line Lead position provides leadership, manufacturing support and coordination of the engineering department for the CMO line specific projects.

This position ensures that contract projects, equipment functionality, compliance support, and capital expenditures are executed per Company management initiatives, compliance guidelines, the project management system, and the capital budget schedule.

It is the responsibility of this position to ensure line specific compliance of the CMO equipment and team with state, local, and federal regulations.

This position ensures operations and projects are carried out under adherence to GEPs and cGMPs.

Job Functions and applications in cGMP settings.

1. Provide technical oversight and leadership to the engineering team roles responsible for their area of responsibility within the CMO Business Unit.
2. Drive technical improvements and internal/external responses to equipment and facility observations.
3. Management of the assigned capital project schedules and budgets.
4. Assign and oversee engineering projects including internal capital, compliance, and contract manufacturing.
5. Coordinate and supervise engineering resources to ensure adequate and appropriate staffing for current and upcoming projects.
6. Ensure designated area, equipment and engineering infrastructures are compliant to local, state, federal, and international regulatory agencies.
7. Execute high level projects from conception, consistent with upper management objectives for business growth.
8. Manage and execute facility and equipment updates to meet company growth and economic objectives.
9. Support client audits and technical visits.
10. Effectively communicate project status, constraints and current or potential issues to upper management.

Candidate Must Have:

• Bachelors of Science in Engineering or related technical degree.
• 5+ years of Engineering Experience
• 3+ years of Engineering experience in the BioPharma industry
• 2+ years of Project Engineering/Management experience
• Some Leadership, Supervisory experience over Jr. Engineers, Technicians.
• Facility or Manufacturing Engineering Experience
• MS Office suite (Word, PowerPoint, Excel) experience

Candidate Nice to Have:

• BS in Mechanical, Chemical, Electrical, Manufacturing engineering
• Advanced degree or PE or PMP certification
• Experience with PM Software – MS Project, Design software - AutoCAD & ERP – SAP
• Experience with Pharma sterile aseptic manufacturing, filling, Lyophilization
• Interfacing with OEM equipment vendors, Construction/consulting partners

Keywords: Projects, Plant Project, engineering, Pharma, CDMO, manufacturing, plant, FDA, GMP, Sterile Aseptic liquid filling, Isolators, Clean rooms, Lyophilization, contract Manufacturing, Supervisor, Lead

Title: Master Production Scheduler

Location: Greater Boston Area, MA (100% onsite)

Employment Type: Contract (6+ months)

Status: Accepting Candidates

About the role

Seeking a scheduling lead to serve as the site’s master production scheduling owner within a manufacturing environment. This role drives alignment across functional schedulers, leads governance forums, and owns scheduling metrics, systems accuracy, and dashboard visibility.

Key Responsibilities

• Serve as Master Production Scheduler, maintaining the site scheduling source of truth
• Lead recurring Scheduling Governance Forums, including agenda, facilitation, documentation, and follow-up
• Develop and own Scheduling KPIs (adherence, stability, execution performance)
• Track and analyze schedule performance trends and drivers of deviation
• Build and maintain Smartsheet workflows and dashboards for scheduling visibility
• Ensure disciplined use and accuracy of Scheduling Systems across function

Qualifications

• Bachelor’s degree in Operations, Supply Chain, Engineering, Business, or related field
• 5+ years of experience in Scheduling, Supply Chain, Manufacturing Operations, or Program Management
• Experience acting as a Central Scheduler, Systems Owner, or Planning Integrator
• Strong experience with Smartsheet
• Pharma experience preferred; manufacturing background required

Compensation (MA Pay Transparency):

• Estimated hourly range: $50–$65/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.

Management Consultant – Life Sciences AI and Project Management New York City (Hybrid)

We are seeking an experienced management Consultant (manager level) to support a major pharmaceutical client in enhancing their AI capability and executing a number of enterprise-level initiatives. This hybrid role requires periodic on-site presence (1-2 days per week) in Hudson Yards alongside remote flexibility, with direct engagement at the senior stakeholder level. Initial project is set for 2 years, with planned rollover to other projects with the same client thereafter. Excellent work/life balance (client hours and primarily remote) and exposure to senior decision-makers in a rapidly evolving area.

Key Responsibilities

• Oversee enterprise-level workstreams within a top-10 pharma
• Work closely with senior stakeholders to design and implement plans for integrating AI into operations
• Structure and manage cross-functional initiatives, tracking milestones, managing risks, and driving accountability across teams
• Develop high-quality executive deliverables including presentations, roadmaps, and status reporting materials
• Facilitate working sessions and stakeholder interviews; synthesize findings into clear, actionable recommendations

Required Qualifications

• Must be located in commutable distance to New York, New York, United States
• 7+ years of consulting experience, with demonstrated focus in pharmaceutical, life sciences, or healthcare compliance at the manager level
• Background at a major consultancy (e.g., Deloitte, PwC, Accenture, BCG, or equivalent) required
• Working knowledge of AI tools and their practical application in regulated industry settings
• Exceptional proficiency with Microsoft Office suite, particularly PowerPoint, Excel, and Teams
• Strong executive communication and presentation skills; comfort engaging C-suite and senior leadership audiences
• Proven ability to manage multiple workstreams independently in fast-moving, ambiguous environments

Ideal Candidate A strategic thinker and disciplined project manager who brings a robust consulting skillset and knowledge and interest related to life sciences and AI.

Compensation Very highly competitive; commensurate with experience.

Position Summary:

As a MEDITECH Expanse Oncology Analyst you will support our Expanse go lives. Expected travel 50%

Responsibilities

• Assists with documentation that relates to technical, functional requirements, or documentation that provides client system guidance.
• Uses knowledge to contribute to Client workflow and gap analysis, independently with general/moderate guidance to complete documentation utilizing department standards.
• Assist in post-live activities inclusive of system and workflow optimization
• Prioritizes own tasks and is able to follow instructions to execute tasks.
• Is able to identify risk and issues and follow escalation plan.
• Understands project deliverables and assigned level of effort (LOE) to complete and monitors own effort to stay within project LOE definition.
• Participates in the Lessons Learned process and contributes to the process improvement process.
• Executes projects task within defined scope and timeline, appropriately following, implementation management methodology.
• Adheres to proper project tracking, for issue & risk escalation processes and completes status reporting per project/department requirements.
• Communicates feedback from clients and escalates to project leadership.
• Uses professional knowledge and experience to advise the client on optimal workflows and system functions.
• Participates in post project review and documentation revision with general/moderate supervision.
• Uses experience to develop client deliverables including, but not limited to, requirements documents, functional design documents, status reports, etc. with general/moderate supervision

Requirements

• Bachelor’s degree is preferred
• Expanse knowledge in clinical application required, preferably Oncology.
• Expected travel 2 weeks for every Expanse go-live (every 2-3 months or so)
• Hospital operational experience strongly preferred.
• Experience in full EHR lifecycle consulting required
• Experience in participating with project team or independently with general/moderate supervision to complete project work.
• Intermediate to Expert ability to work in Office suite products: Outlook, Word, Excel, Visio, and Power Point
• Good organization skills as well as strong written and oral communication skills.
• Experience working in a team-oriented, collaborative environment.
• A sense of responsibility and accountability; someone who takes ownership and initiative.
• Adaptable and flexible.
• Professional demeanor and positive attitude; customer service orientation.
• Ability to learn new technologies, methods, and processes.
• Respect for diversity of experience, characteristics, viewpoints, and opinions.
• Preference given to candidate who lives within 60 miles of an HCA location.

Hello Jobseekers

We are hiring Associate to Sr. Manufacturing Engineer to lead and provide ongoing support through our manufacturing life cycle!

Title : Manufacturing Engineer

Location : Pontiac IL

Duration : 6-12 months

No benefits

Lead PFMEA activities in coordination with product development, quality, and manufacturing engineering teams.

Participate in DFM and DFA activities to define manufacturing processes for new product and product enhancement programs.

Develop manufacturing assembly and test methods to ensure Critical to Quality (CTQ) requirements are met.

Must haves:

Bachelor’s degree at a Minimum

Only Candidates with a Medical Device Background

5+ years of experience working in an FDA/ISO regulated medical device/medical equipment manufacturing environment.

Must have prior NPI Manufacturing and/or Process Development experience, including disposables and capital equipment.

Test Method Validation and Verification (TMV, V&V)

Job Purpose

Responsible for the execution of all aspects of solid-dosage manufacturing which includes, but is not limited to, the dispensing, granulation, sifting, milling, drying, encapsulation, coating, compression, and cleaning related activities. Must be able to interact daily with all site support personnel as required. Must be able to complete all required batch record documentation in a thorough, accurate, and legible manner in English. Must be capable of reading and understanding all documented Standard Operating Procedures in English plus demonstrate competency through action and written evaluation.

Essential Duties and Responsibilities include the following. Other duties may be assigned:

• Assist Production Management with all scheduled and requested activities in an efficient and smooth operation.
• Ensure all scheduled commercial and non-commercial manufacturing activities are completed on time.
• Become proficient in the setup, operation, and cleaning of all cGMP equipment used during production operations.
• Participate in all Quality Investigations as required.
• Adhere to all approved Standard Operating Procedures, Batch Records, and Safety Procedures as written when performing all daily activities.
• Ensure the cGMP area is cleaned and maintained following all SOP’s and good housekeeping practices.
• Must use required PPE during cGMP activities as specified in the Batch Records and Safety Data Sheets.

To perform this job successfully, an individual should have:

• Familiarity with working in a regulated pharmaceutical solid dosage facility.
• Ability to read and write documents written in English.
• Excellent written communication skills.
• Familiarity with various cGMP solid dosage Pharmaceutical manufacturing equipment. Able to setup, operate clean, and troubleshoot the solid dosage Pharmaceutical manufacturing equipment being used.
• Able to work with minimal supervision.
• Able to stand on feet throughout an eight-hour work day.
• Able to lift up to 30 Ibs (14 Kgs) without assistance.
• Maintain personal hygiene habits consistent with working in a cGMP environment
• Be capable of wearing all required PPE; including partial and full facepieces based on OSHA guidelines.

Education :

High School Diploma or GED Equivalent.

Bachelor’s degree in Physical Sciences or Pharmaceutical life science related field of study.

Years of related experience

2-8 years related experience in cGMP production operation activities.

Must have Valid work permit.

JOB TITLE: Senior Rebate Analyst

LOCATION: Weston, FLHybrid

SCHEDULE: Monday - Friday | 8:30 AM - 5:30 PM

DESCRIPTION:

A leading organization in a highly regulated industry is seeking a Senior Rebate Analyst to support its Finance team. This role is responsible for managing and analyzing customer rebates, discounts, and allowances while ensuring contractual accuracy, financial integrity, and regulatory compliance.

The ideal candidate brings strong rebate experience, analytical expertise, and the ability to translate complex agreements into accurate financial reporting and actionable insights.

KEY RESPONSIBILITIES:

• Analyze and validate customer rebates, discounts, and allowances.
• Interpret customer contracts to ensure accurate calculations and payments.
• Support rebate forecasting, accruals, and month-end close processes.
• Prepare variance analysis and executive-level financial reporting.
• Perform GL reconciliations and maintain accurate rebate tracking.
• Partner with Accounting, Audit, Government Pricing, and Commercial teams.
• Assist with audit support and regulatory compliance requirements.
• Identify and implement process improvements within rebate operations.
• Mentor junior analysts and serve as a subject matter expert.

REQUIREMENTS:

• Education: Bachelor’s degree in Accounting or Finance.
• Experience:8+ years of rebate and financial analysis experience within a regulated environment.
• Pharmaceutical rebate experience strongly preferred.
• Skills:Strong Excel and Microsoft Office proficiency.
• Solid understanding of contracting and chargeback processes.
• Excellent analytical, organizational, and communication skills.
• Ability to manage multiple priorities and handle confidential information with integrity.

At ttg, "We believe in making a difference One Person at a Time," ttg OPT.

Project Overview

This project involves gutting an existing office space and converting it into an expanded pharmaceutical manufacturing suite. The end state will be a GMP-compliant manufacturing environment. The company is acting as the General Contractor, overseeing architectural, mechanical, and electrical scopes.

Position Summary

The Site Superintendent will serve as the on-site lead, managing all day-to-day construction activities and subcontractor coordination while ensuring safety, schedule adherence, and quality execution. This role will work closely with a Project Manager who will be on site three days per week, along with additional leadership support visiting weekly.

This is a highly visible role with direct owner interaction, and strong performance could lead to future project opportunities or a potential long-term role as additional work is awarded.

Key Responsibilities

• Manage daily on-site construction activities while acting as the primary field representative for the General Contractor
• Coordinate and oversee architectural, mechanical, and electrical subcontractors
• Enforce site safety standards and maintain OSHA compliance
• Manage day-to-day permits, inspections, and owner-required documentation
• Serve as the primary point of contact with the owner, maintaining professional and clear communication
• Track progress against schedule and proactively address field issues
• Ensure work is executed in alignment with pharmaceutical/GMP expectations
• Collaborate closely with the Project Manager (on site 3 days/week) and senior leadership support (1 day/week on site)

Pre‑Construction / Onboarding Expectations

• One week of onboarding in the Raleigh office prior to mobilization
• Review drawings, scope, schedule, and project expectations
• Flexible hours during onboarding week
• Company support available for travel costs; per diem can be built into the model if needed

Required Qualifications

• OSHA 30 Certification
• 10+ years of experience as a Site Superintendent or similar role
• Proven experience managing multi-discipline construction projects up to $5M
• Pharmaceutical or GMP project experience
• Strong mechanical background (preferred discipline)
• Experience working with mechanical and electrical contractors on complex builds
• Ability to confidently interface with owners and stakeholders
• Local to the project area (no per diem offered)

Company Description

Bird Dog Pharma helps medical practices seamlessly integrate physician-directed allergy care into their routine clinical workflows, ensuring continuity of care for patients. Focused on empowering practices to address allergy-driven conditions such as asthma, eczema, and sinus complaints, Bird Dog Pharma supports providers with in-office testing, personalized immunotherapy, and operational integration. By simplifying allergy care, we enable physicians to deliver comprehensive treatment within their own offices. Our mission is to make allergy care practical, sustainable, and accessible for healthcare providers.

Role Description

This is a contract, remote position for a Medical Sales Representative. The role involves engaging with medical practices to promote and support the adoption of Bird Dog Pharma's allergy care solutions. Responsibilities include building and maintaining client relationships, educating healthcare professionals on the company's offerings, and identifying opportunities to expand sales territories. The ideal candidate will conduct market research, provide customer service to medical providers, and achieve sales goals while maintaining a consultative approach.

Qualifications

• Proven experience in Medical Sales and a track record of meeting or exceeding sales targets
• Strong Communication and Customer Service skills for building relationships and delivering excellent support
• Knowledge of Medicine and Pharmacy principles, with a focus on allergy care or a related field
• Self-motivated with the ability to work independently in a remote capacity
• Experience working with healthcare professionals or within a clinical environment is preferred
• Strong organizational skills and adaptability to meet the needs of a fast-paced, dynamic role

Job Summary:

To provide product management, modeling and commercial analytics to support PAI’s strategic product development and life cycle management. This role will manage the functions including product forecasting, 5YSP/Budget, competitive analytics, business management and insights reporting and product launch coordination to support growth and sales operations.

• Responsible for supporting business case development, business development modeling, and modeling new product targets

• Responsible for performing commercial analytics, insight generation and competitive analysis

• Supports launch planning

• Contributes to Finance quarterly planning cycle for 5YSP/Budget

• Supports portfolio sales economics

• Provides holistic support to Finance & Leadership teams

Duties and Responsibilities:

1. Lead commercial business insights and reporting to support growth and commercial execution, to include but not limited to competitive and market share analysis, business and competitive intelligence reporting, product performance and ad-hoc.

2. Lead the product forecasting/modeling for all commercial products which supports business case development, demand planning, manufacturing readiness, and financial budgeting.

3. Contributes to finance quarterly planning cycle, including owning commercial re-forecasting model and supporting portfolio sales economics.

4. Manages various in support of overall analysis of PAI Pharma’s revenue, including holistic support of the finance and leadership teams in understanding portfolio changes, even those driven outside the commercial team (BD, R&D, etc.)

5. Delivers adhoc analysis in conjunction with finance team in support of commercial, executive, & finance leadership

6. Be the product expert.

7. Support the development of marketing materials to support existing and new product launches, including sell sheets, product catalog, PR, advertising, podium, white papers, etc.

8. Support and coordinate the execution of new product launch plans.

9. Support commercial and market assessment to drive execution of new product launches and achieve product targets.

10. Support the management and reporting of pipeline postmortem and launch success tracking.

11. Nurtures a team environment of accountability, continuous improvement and best-in-class performance.

12. Assist and manage projects to meet organizational and customer requirements.

ACCOUNTABILITY

For the accuracy and timeliness of all work performed.

SUPERVISORY RESPONSIBILITIES

Manage the product management for assigned products and business analytics process to drive commercial execution.

Education and Experience:

Proven working experience in marketing and product management, preferably in the generic pharmaceutical industry

• Working knowledge of data management and business analytics to derive business and competitive insights

• Ability to think strategically and to lead

• Strong client-facing and communication skills

• Advanced troubleshooting and multi-tasking skills

• Skilled in Excel, PowerPoint and Word

• Solid proficiency and knowledge of commonly used pharmaceutical industry databases like IQVIA, ProspectoRx, First Databank, etc.

• Knowledge of FDA websites

• BS degree in Business Administration or related field

• Minimum 5-7 years of industry related experience

The pay range for this position at commencement of employment is expected to be between $100,000-$140,000; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position will also include benefits such as medical, prescription drug, dental and vision insurance, flexible spending accounts, participation in 401(k) savings plan, and various paid time off benefits, such as PTO, short- and long-term disability and parental leave, dependent on the position offered. Details of participation in these benefit plans will be provided to employees who receive an offer of employment.

If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Physical Requirements/ Working Conditions:

EQUIPMENT AND MACHINES

Personal computer and standard office equipment.

WORKING CONDITIONS

Office environment. Occasional business travel may be required.

To perform this job successfully, an individual must be able to perform the essential job functions satisfactorily. PAI is an Equal Opportunity Employer. In compliance with the Americans with Disabilities Act, PAI will provide reasonable accommodations to qualified individuals with disabilities and encourages both prospective and current employees to discuss potential accommodations with the employer. PAI uses E-Verify.

PAI Pharma is a nicotine-free campus, meaning the use of nicotine products—including cigarettes, vaping, chewing tobacco, and any other nicotine-containing substances—is strictly prohibited on company property. All employees should be able to complete their full shift without the need to use nicotine. By joining PAI Pharma, you agree to adhere to our nicotine-free workplace policy, which supports a healthier environment for all employees.

EEO Employer / Veteran / Disabled

At MEDITECH, we sit at the nexus of healthcare and technology - two rapidly evolving industries. Account Executives play an essential role as a part of this growth. As an Account Executive, you will be responsible for marketing and selling our cutting-edge enterprise health record solutions and services to C-suite, boards, physician and nurse leadership, and other senior healthcare leaders at health systems, independent hospitals, and ambulatory healthcare networks.

Ultimately operating under the direction of the Regional Sales Director and with a focus at the following levels: C-suite, Physician, Clinical Nursing, Financial leadership, Account Executives maintain close relationships with all key stakeholders, helping to foster and cultivate opportunities for selling and strengthening partnerships with MEDITECH. As a member of our Sales team, your job would involve:

• Selling MEDITECH's standard solutions and services; maintaining overall responsibility for successfully executing each phase of the sales cycle
• Maintaining primary deal design responsibility which includes the assessment of an opportunity to ensure a clear understanding of business needs, competitive landscape, decision-makers, and influencers in order to define an overall engagement strategy
• Nurturing the primary contact with existing MEDITECH customers under your assignment. Proactively engaging with C-suite and clinical leadership, monitoring organizational changes of any kind, communicating with senior MEDITECH leadership on account status and level of MEDITECH EHR satisfaction
• Creating and following the blueprint for successful C-suite customer engagement in terms of sales standard benchmarks including annual strategic presentation to sites, consistent alignment of goals, cultivation of relationships, and keen awareness around any organizational change or shifts in dynamics
• Developing and maintaining a comprehensive understanding of all MEDITECH solutions and services
• Maintaining up-to-date knowledge and perspective on healthcare and technology industry issues and trends, specifically those which impact hospitals and health systems
• Maintaining active territory management and engagement to achieve assigned individual performance and bookings targets commensurate with division and regional goals
• Possessing a capacity to effectively deliver strategic MEDITECH presentations and overviews to senior-level audiences at customer and prospect organizations
• Ongoing utilization of Salesforce CRM solution to maintain accurate, timely, standardized account profiles and documented sales opportunities
• Ensuring the timely and accurate completion of responses to Requests for Information (RFIs) and Requests for Proposal (RFPs)
• Attending approved trade shows and regularly scheduled internal sales meetings and educational sessions
• Coordinating, staging, and engaging in the effective demonstrations of MEDITECH software solutions
• Presenting high-level software solutions and executive-level presentations, as assigned, to key buyers of influence at an executive level (physicians, nursing/quality, financial solutions)
• Ensuring a consultative approach to selling at all times
• Meeting or exceeding required bookings quota for this position
• Covering assigned territories, and traveling 50% of the time

Requirements

• Bachelor's degree required, along with 3-5 years of applicable direct sales or sales engineer experience
• Strong knowledge of MEDITECH and MEDITECH solutions preferred
• Exceptional written and verbal communication skills
• Exceptional presentation skills
• Proven track record of sales success in closing business, accompanied by a high degree of professionalism
• Strong customer engagement skills
• Ability to cultivate, nurture, and maintain strategic relationships with buying organizations
• Proven, consistent ability to deliver sales performance in bookings
• Proven ability to meet deadlines, targets, and booking goals as defined
• Passion for and understanding of healthcare industry initiatives and practices
• You may be required to show proof of vaccination when traveling to a customer site unless you have an approved medical or religious exemption.

Hiring salary range: $72,000 - $90,000 per year.

Actual salary will be determined based on an individual's skills, experience, education, and other job-related factors permitted by law.

MEDITECH offers competitive employee benefits including but not limited to health, dental, & vision insurance; profit sharing trust and 401(k); tuition reimbursement, generous paid time off, sick days, personal time, and paid holidays.

This is a hybrid role which includes a blend of in-office and remote work as designated by the management team.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. MEDITECH will not sponsor applicants for work visas.

Are you an experienced supply chain professional who thrives in fast‑moving global environments? Sirio Nutrition is looking for a Supply Chain Manager to lead our end‑to‑end logistics operations for products manufactured in China and delivered to customers across the U.S.

This is a high‑impact role owning the full international supply chain from production readiness to customs clearance to final delivery. If you’re analytical, detail‑oriented, and comfortable coordinating across global partners, regulatory agencies, and customers, we’d love to meet you.

What You’ll Do

• Manage the full export lifecycle of food‑related products from China to the U.S.
• Oversee freight forwarding, shipping vendors, brokers, port coordination, and last‑mile delivery.
• Serve as the main contact for regulatory agencies including FDA, U.S. Customs, and port authorities.
• Ensure compliance with all food import regulations, documentation requirements, and customs procedures.
• Monitor tariffs, duty rates, HS codes, and global trade updates; analyze financial impact and landed cost.
• Collaborate closely with Sales, Operations, Quality, Regulatory, Customer Service, Finance, and Sirio Pharma in China.
• Build and maintain strong relationships with carriers, vendors, agents, brokers, and customers.
• Identify process bottlenecks, track KPIs, and drive continuous improvement.
• Coordinate customer deliveries within the U.S., ensuring a smooth post‑import experience.

What You Bring

• 3+ years of experience in supply chain, logistics, or global trade roles.
• Experience in nutritionals, consumer health, food, or regulated products preferred.
• Advanced Mandarin and English proficiency (speaking, reading, writing, translating).
• Strong understanding of international shipping, U.S. Customs, FDA requirements, and import processes.
• Analytical skills with the ability to interpret operational and financial data.
• Proficiency in Microsoft Office and supply chain/ERP systems.
• A proactive, collaborative, problem‑solving mindset.

The Company reserves the right to modify, update, change and/or make corrections to this job description, at the sole discretion of senior management, at any time during the employee’s employment term, at the sole discretion of management.

Siro Pharma is an employer committed to inclusion and diversity. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.

Company Overview:

Luye Pharma is fast-growing pharmaceutical company committed to advancing innovative therapies for Central Nervous System (CNS) disorders, with a primary focus on schizophrenia. Our pipeline includes promising new treatments such as Erzofri and Rykindo, which are set to launch in the U.S. market.

Position Summary:

In this role, you will collaborate closely with the US Head of Commercial Operations to design, implement, and manage data analytics and performance reporting systems. Your main responsibility will be to provide actionable insights that support decision-making and drive improvements in commercial outcomes. As the Manager of Commercial Analytics, you will serve as a key analytics partner for commercial leaders across sales, marketing, and operations in the US. You will offer valuable insights and recommendations to fuel growth, optimize field performance, and analyze market and patient trends. Additional key responsibilities include developing reporting processes and assisting with the coordination of Monthly Business Reviews, focusing on KPIs, forecasting variances, and updates to the Latest Estimate.

Report to: Head of Commercial Operation

Key Responsibilites:

• Develop and maintain performance dashboards and reports, integrating internal KPIs and external datasets to track business metrics, monitor progress toward sales goals, and evaluate operational performance.
• Conduct in-depth analysis of market trends and product performance to identify growth opportunities and risks.
• Evaluate overall business performance, including volume, market share, new patient starts, and KPIs, comparing actuals against forecasts and targets.
• Partner with Sales and Commercial Leadership to optimize territory alignments, call planning, and customer targeting, using analytical insights to improve sales coverage and operational efficiency.
• Assess performance and activity trends at sub-national levels to uncover opportunities, inefficiencies, and areas for improvement within the sales force.
• Prepare monthly business reviews, utilizing a combination of third-party market data (e.g., prescriber, chargebacks, 867, 852 data) and internal performance metrics to guide executive decision-making.
• Build and maintain performance dashboards and reports by integrating internal KPIs and third-party datasets to monitor business metrics, track progress against sales goals, and evaluate operational performance.
• Assist in designing incentive compensation structures and performance metrics, including goal setting and attainment analysis.
• Analyze market trends, physician and account-level data, and promotional effectiveness to support segmentation, targeting, and brand strategy.
• Provide support to field teams by addressing data and reporting requests, resolving inquiries, and delivering actionable insights for daily execution.
• Collaborate with cross-functional teams to develop demand forecast models.
• Conduct data analysis, reporting, and generate actionable insights to support commercial brand strategy and execution.
• Other duties as assigned.

Qualifications:

• Bachelor’s degree
• 3-5 years of experience in relevant analytics roles within the pharmaceutical or life sciences industry.
• Strong understanding of the pharmaceutical industry and familiarity with third-party data sources (e.g., Symphony Health, IQVIA, etc.).
• Strong proficiency in Excel
• Exceptional analytical capabilities, including the ability to manipulate large data sets and apply advanced analytical methodologies.
• Experience with BI tools (Tableau, Power BI, Qlik etc.) preferred.

To all recruitment agencies: Luye does not accept unsolicited third party resumes, and all resumes must be submitted to HR Function.

The starting compensation range(s) for this role are listed for a full-time employee (FTE) basis. Additional incentive may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Luye Pharma is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

Medical Device Sales Associate needed!

About the Opportunity:

We are seeking a driven Associate Interventional Specialist to support a high-performing Territory Manager in the Westchester/Fairfield County territory. This is a growth opening due to internal promotion and offers strong development into a full Territory Manager role. This is an exciting time to join a profitable, expanding organization committed to improving the lives of chronic pain patients within the neuromodulation and broader musculoskeletal space.

Key Responsibilities:

• Support Territory Manager with daily field activity and account coverage
• Assist in implant procedures and provide in-OR clinical support
• Provide programming and reprogramming support for patients
• Educate physicians, clinical staff, and patients on therapy and product benefits
• Conduct sales calls to maintain and grow existing accounts
• Manage assigned target accounts as designated by the District Sales Manager
• Develop new business through trial generation and account penetration
• Plan and execute local educational programs and sales events
• Maintain inventory and territory organization
• Complete all compliance and regulatory training requirements

What We’re Looking For:

• 1–3 years of business-to-business sales experience (medical device, pharma, biotech, clinical, or related industry preferred)
• Bachelor’s degree required
• Strong communication and influencing skills
• High character, strong work ethic, and willingness to work flexible hours (including occasional weekends for procedures)
• Valid driver’s license and ability to travel daily within the territory
• Not a job hopper — demonstrated tenure and career progression preferred
• Operating room experience is not required. Candidates from structured sales training environments (e.g., enterprise sales organizations) or early-career medical device professionals are encouraged to apply.
• MUST live within the territory (Danbury/Westchester/Fairfield, CT)

1-year initial contract

Nice to have: Manufacturing, Warehousing, and Pharma experience.

The ideal candidate will have some prior industry experience, with a strong preference for those who have worked in clean room environments such as pharmaceuticals, hospitals, or other controlled settings. Familiarity with gowning procedures and hygiene/cleaning requirements is essential. The role involves material handling responsibilities, including moving materials between areas, cleaning raw materials, retrieving and storing inventory, and operating electric pallet jacks and potentially tuggers. While forklift certification is a plus, it is not required.

Job Details:

• Following Good Manufacturing Practices (GMPs) and applicable regulations from the Code of Federal Regulations (CFRs).

• Reporting any discrepancies to the Team Leader or Production Supervisor to ensure quality standards and safety.

• Ensuring quality & compliance through a Right First-Time mentality.

• Receiving and preparing components for use in manufacturing.

• Feeding components into equipment and performing sanitation activities.

• Documenting appropriate paperwork, understanding Overall Equipment Effectiveness (OEE)/performance metrics, and participating in daily performance meetings.

• Use of pallet jacks and manual wrapping of pallets.

• Use of computer systems to support material inventory and electronic batch record.

• Partnering with cross-functional teams to drive improvement opportunities.

• Ensuring components and products are available for continuous operation

Job Summary:

The Sr. Director of Quality Compliance directs Governance, Audit, Inspection, Escalation and Risk Management and is a valued member of the PAI Quality Leadership team. The incumbent will direct, consult, develop, implement, maintain, and ensure that the overall cGMP compliance profile is maintained effectively. This role will ensure the development and implementation of compliance processes and systems in a manner consistent with global quality systems requirements, corporate standards, current regulatory and client requirements. The role will engage effectively with health authorities and identify mechanisms to assure that our practices and policies meet current regulatory expectations.

The incumbent will direct the quality notification to management program through escalation of quality events and the governing processes. The role will manage the DEA compliance, external and internal audit programs, and CMO audit requirements. The incumbent will lead continuous improvement programs and support compliance and risk activities.

We are seeking an ideal candidate who can establish a Quality Compliance strategy and direction throughout the organization.

The incumbent will work to ensure continuous improvements regarding the most recent national and international cGMP compliance standards and to accomplish compliance in the most efficient way. The position will, develop and lead inspection readiness programs and provide guidance on all compliance related matters. They will advise on industry issues and regulatory changes that may affect PAI. This role involves developing and implementing strategies to ensure compliance with regulatory standards, conducting audits and inspections, and managing quality-related issues to maintain the company's integrity and reputation.

Key Responsibilities:

• Develop and implement quality compliance programs and policies.

• Conduct internal and external audits to ensure compliance with regulatory standards and company policies.

• Quality Compliance and Internal Audit - Directs the activities for conducting internal audits across the Business Unit and manages all external audits by Notified Bodies, FDA, DEA and other Competent Health Authorities.

• Oversee inspection processes and ensure readiness for regulatory inspections.

• Manage escalation processes to address and resolve quality issues promptly. Notifies executive leadership through corporate quality escalation program.

• Direct and Communicate Notification to Management regarding escalated quality events

• Collaborate with cross-functional teams to implement quality compliance corrective and preventive actions (CAPAs).

• Monitor and review quality assurance and quality control data to identify trends and areas for improvement.

• Prepare and maintain documentation related to compliance, audit, inspection, and escalation activities.

• Provide training and support to employees on quality compliance and audit practices.

• Stay updated on industry regulations and standards to ensure ongoing compliance.

• Report to senior management on quality compliance, audit, inspection, and escalation activities and progress.

• Post Market Surveillance - Directs the activities to comply with regulatory requirements for post-market surveillance of PAI products on the required schedule for adequacy of product instructions for use, risk management, performance and other key factors.

• Compliance and Internal Audit - Directs the activities for conducting internal audits across the Business Unit and manages all external audits by Notified Bodies, FDA, DEA and other Competent Authorities.

• Tracks and trends Quality Indicators.

• Interfaces with all PAI manufacturing facilities as well as other Business Unit functions.

• Executes on Quality Goals as approved by the Quality Leadership Team.

• Ensures maintenance all required records for the QMS.

• Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.

• Provides leadership for the overall Quality Compliance Escalation & Notification to Management process and associated CAPAs.

• Analyzes internal quality systems and associated data to assure adherence to QSRs, DEA, and other international standards (ICH), PAI quality standards, and Business Unit and Facility quality standards.

• Develops, reviews and maintains Quality Policies.

• Reviews Quality audit reports and prepares appropriate corrective action responses.

• Establishes and leads an inspection readiness program. Provides on-site support for inspection management for key inspections.

Qualifications:

• Bachelor’s degree in: Pharmacy, Chemistry, Biology, Chemical Engineering, or relevant discipline.

• Minimum of 15 years of experience in quality assurance, quality control, or risk management within the pharmaceutical industry at a senior leader level.

• Knowledge of systems and processes which support Quality management. Specifically, operational experience in the core QMS processes such as document management, change control, deviation handling, quality control, good distribution practices, supplier quality management, and escalation to management processes.

• Demonstrated excellent interpersonal, written and verbal communication skills, and demonstrated ability to prepare written reports, correspondence and presentations to senior leadership.

• Experience recognizing the broad, systemic implications of problems and issues and demonstrated experience with negotiating win-win solutions for a broad range of global QMS initiatives.

• Comprehensive understanding of auditing principles and ability to perform as a lead auditor. Experience with regulatory authorities from an auditing perspective with regulatory experience in a pharmaceutical GMP environment required.

• Knowledge of Quality best practices and experience with technology tools to support the

• Extensive knowledge of global quality regulations, industry or international standards and ability to interpret and implement.

• Ability to understand Regulatory, Business Unit and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency at the Business Unit & Plant levels.

• Ability to interface with regulatory bodies to defend quality compliance.

• Proven leadership ability and experience building and maintaining positive relationships globally, both internally and externally.

• Broad expert knowledge of pharmaceutical, API, Aseptic, and OTC manufacturing processes and regulations.

Skills & Competencies:

• Knowledge, experience, and skills with quality assurance functions; and the use of information technology platforms. Track record of strong involvement with industry professional associations is preferred. Capability to network within the pharma industry and partner strategically with health authorities/regulators.

• Industry experience in applying predictive analytics and big data/artificial intelligence to create predictive indicators of quality manufacturing

• Capability to collaborate effectively with across global quality network

• Listening, negotiating and effective communication skills under pressure are highly preferred. Business minded and customer focused.

• Responsible for monitoring sponsored studies for compliance with PAI quality standards, regulatory agencies requirements, and if applicable, global standards/requirements

• Ensures that company products meet defined quality standards through management oversight

• Directs, initiates, plans, and develops processes and projects to define and implement quality assurance practices within manufacturing operations in line with organizational policies, standards, and guidelines. Ensures overall quality control of processes, raw materials, and products in line with regulatory and industry standards.

• Manage Quality and Compliance teams so that Quality Management Systems PAI sites in compliance with all relevant legislation and controls; and relevant guidelines are fully addressed in a way which is relevant to our sector of industry and dosage forms, proportionate, appropriate and sustainable.

• Directs and manages audit processes and reporting requirements designed to support the functional area strategies that align with the principles and values of PAI.

• Quality Assurance

• Quality Risk Management

• Quality Compliance Management

• Quality Control

• Process Improvement

• Data Analysis

• DEA and DSCSA Standards

PHYSICAL REQUIREMENTS / WORKING CONDITIONS:

• The physical requirements and working conditions listed for this job are representative of those required on the job. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential duties and responsibilities. Typical office environment requiring the use of typical office equipment (e.g., computers, phones, etc.). Computer keyboarding, computer monitor and mouse use including reaching forward, grasping, finger and wrist manipulations, and neck bending and turning: near vision is necessary for computer monitor use. Continuously required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, frequently required to stand, sit, walk, talk and hear, occasionally required to reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl. Ability to lift to 30lbs.

• PAI is an Equal Opportunity Employer. PAI uses E-Verify.

• EEO Employer / Veteran / Disabled

JOB DESCRIPTION

The Research and Development Operator I would operate, clean, disassemble, and reassemble equipment such as blending, granulation, compression, and coating machinery in accordance with applicable cGMP and SOPs. In this role, the incumbent would rotate between Pilot Plant and Manufacturing departments as determined by the needs of the business.

Essential Duties & Responsibilities

• Proficiently operate, disassemble, assemble, and clean equipment.
• Operate, disassemble, assemble, and clean equipment in other departments proficiently.
• Routinely perform housekeeping assignments, maintain cleanliness and routine maintenance of the work area and equipment.
• Uses computer to read, review, and train on SOPs.
• Review current SOPs and provide feedback on potential process improvements.
• Participate in work scheduling. Handle computer transactions/metrics for the department.
• Record operating data within batch records in accordance with cGDP.
• Review and record completed production documentation (batch records, logbooks, etc.) for quality and cGMP compliance.
• Able to troubleshoot production processes and notify applicable parties for assistance.
• Recognize and report manufacturing incidents. Support investigations and support CAPA’s on occasions.
• Builds productive, trusting, and respectful relationships at all levels in the organization and must consistently act as a team player.
• Collaborate effectively and communicate with other functional groups, including quality, validation, and supply chain to ensure production goals are achieved.
• Follows Piramal Pharma Solutions Safety, Health, and Environmental policies and procedures.
• Maintain confidentiality for all clients and activities in the development process.
• Performs other duties as assigned or as business needs require.

Requirements

• High school diploma or GED required.
• Individuals with equivalent education, training, and experience will be considered.
• Experience in a pharmaceutical, chemical, biochemical, or food manufacturing environment required.
• 2+ years working within an industrial or manufacturing environment preferred.

Physical Requirements

• Lift up to 40 lbs. and occasionally move drums weighing up to 300 lbs.
• Able to work safely with heavy equipment.
• Regularly stand, walk, sit, use hands to finger, feel objects, tools, controls, reach with hand and arms, talk, hear, and good vision.
• Ability to climb ladders, bend, stoop, and kneel.
• Individual may be required to wear Personal Protection Equipment including N95 respirators and Powered Air Purifying Respirators.
• Not allergic to chemicals or bio-substances found in laboratory or production facilities.

SAP Product Cost Manager, 170k plus bonus, Princeton, International Pharma Company

US CITIZEN OR GREEN CARD ONLY

US CITIZEN OR GREEN CARD ONLY

HYBRID MODEL, 3 DAYS ON SITE

NO REMOTE WORK

MUST HAVE BEEN THROUGH 3 TO 4 FULL LIFECYCLE SAP IMPLEMENTATIONS

• Own the implementation, design, configuration, and continuous enhancement of SAP S/4HANA Product Costing (CO-PC) including standard cost planning, Material Ledger, cost component split, variance analysis, Margin Analysis (CO-PA), and Cost Center Accounting.
• Implement and manage cost center planning, activity type planning, overhead costing sheets, template allocations, and cost assessments/distributions. Support budgeting cycles and financial forecasts integrated with SAP S/4HANA.
• Manage and govern seamless integration between Controlling and related modules such as Financial Accounting (FI), Production Planning (PP), Materials Management (MM), and Sales & Distribution (SD) to ensure seamless data integration, process alignment and accurate cost flows.
• Oversee and support day-to-day, month-end and year-end processes, which include cost allocations, assessments, project settlements, revaluation, and variance analysis, to ensure accurate and timely financial reporting. Additionally, manage the costing processes, such as cost rollups, inventory valuation, cost estimates, and revaluation of consumption. Ensure the accuracy of the Material Ledger and actual cost flows across multiple plants, company codes, and currencies. 20%
• Act as the SME and escalation point for CO-PC, CO-PA and other CO related incidents. Identify gaps and opportunities for process standardization and automation within SAP CO-PC. Lead process improvements to enhance efficiency, accuracy, and scalability. Perform root cause analysis, recommend corrective actions, and develop functional specifications for RICEFW objects, perform unit/integration/UAT testing and coordinate with developers for RICEF object resolution (Reports, Interfaces, Conversions, Enhancements, Forms).
• Conduct FIT/GAP analysis, develop functional specifications for RICEFW objects, perform unit/integration/UAT testing, and support cutover and go-live activities. Provide ongoing support for system stabilization and continuous improvement initiatives.
• Collaborate with finance, operations, and IT stakeholders to translate business needs into technical solutions. Actively contribute to SAP S/4HANA transformation projects, S/4HANA roadmaps, upgrades, and process improvement initiatives with focus on CO and Product Costing streams.
• Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large.

Knowledge, Skills and Abilities (KSA)

• Exceptional problem-solving, communication, and business engagement skills.
• Excellent communication and presentation skills
• Ability to work on projects with cross functional teams, external resources, and PMO.
• Manage business users independently, be self-motivated, proactive and a team member.
• Ability to embrace new technologies and adopt to an evolving environment.
• Ability to adopt flexible schedule to meet multiple time-zones for meetings with peers and stakeholders.

Qualifications/ Background Experiences

• Bachelor’s degree in Finance, Accounting, or equivalent experience.
• Minimum 10 years of SAP experience with deep focus on Product Costing (CO-PC) and Profitability Analysis (CO-PA).
• Demonstrated experience working in complex, global SAP S/4HANA environments.
• In-depth knowledge of SAP CO modules (CO-PC, CO-PA, PS, CCA) and integration with FI/MM/PP.
• Deep understanding of cost flows, costing variants, overhead calculations, and inventory valuation.

POSITION SUMMARY:

The Instrumentation and Calibration Engineer has the responsibility for ensuring the site’s production instruments are operating at optimal levels and properly maintained to data collection in an FDA regulated environment. The position will be primarily responsible for ensuring all instruments are maintained in a calibrated state. Additionally, the Engineer will support general troubleshooting of production equipment/utilities, and asset management.

To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required:

• Shall adhere to all applicable regulatory requirements, including FDA, EPA, OSHA, and related safety, health and environmental procedures, policies and practices.
• Consistent support and practice of all Piramal Pharma Solutions mission, vision, and values.
• Identify and protect the original technical information as part of the company property.

KEY RESPONSIBILITIES.

• Support the Preventive Maintenance (PM) program through the creation of new PM tasks, evaluation of existing PMs for technical relevance to current asset problems.
• Help create Standard Operating Procedures (SOPs) for equipment operation, engineering analyses, PM and calibration tasks, that adhere to FDA and cGMP requirements.
• Support the management of the calibrations on production instruments, such as temperature sensors (RTDs/resistance thermometers), pressure sensors (electronic manometers, gauges), and other transmitters.
• Support root cause investigations to a detailed level required for an FDA regulated/cGMP environment, and translate these root causes to effective CAPAs that mitigate equipment risk.
• Assesses and monitors equipment for reliability of operation implementing necessary improvements
• Maintains system classification of incoming equipment with the system owner. Duties may include assembly of supplier operating and maintenance manuals, installation and operational qualification.
• Translate data from Root Cause Centered Maintenance (RCCM) data to support Autonomous Maintenance program. Train Operations personnel in Autonomous Maintenance.
• Maintain calibration records, and qualification of calibration contractor.
• Manages risk to achieve organization's strategic objectives in areas of environmental health and safety, asset capability, quality, and production.
• Conducts risk analyses routinely when production equipment is functioning outside of expected parameters
• Develops Total Cost of Ownership, Mean Time to Failure, Life Cycle Cost, Mean Time to Repair, specific to critical equipment in the production areas.
• Runs process improvement projects from design thru implementation. Apply Root Cause Centered Maintenance (RCCM) to develop improved preventive maintenance tasks.
• Executes changes through to completion, from initiation of change controls to revising SWIs, coordinating work with Maintenance/Engineering, etc., to close out of CCs
• Collaborates with other departments to ensure that reliability is integrated into all aspects of the organization
• Participates in and execute qualification and validation of equipment and processes

EDUCATION/EXPERIENCE.

• Bachelor’s degree in an engineering discipline and 3 years of experience in a related or similar field, or
• Associate’s degree in an engineering or scientific discipline and at least 5 years of experience.

JOB COMPETENCIES.

• Analytical thinking: the ability to think critically and logically, as well as the ability to work with large sets of data and make sense of them.
• Technical aptitude: a strong understanding of the systems, equipment, and processes at hand. This includes knowledge of the engineering principles and specific systems used at an organization.
• Mechanical aptitude: an understanding of how mechanical components fit together and support the function of equipment. Demonstrated curiosity for how production equipment functions.
• Problem-solving: the ability to think creatively and come up with innovative solutions to complex problems. Specific experience applying Root Cause Analysis and Root Cause Investigation concepts to determine root causes and create effective corrective actions.
• Communication: the ability to explain technical concepts in a clear and understandable manner, as well as the ability to collaborate effectively with others. The ability to generate highly technical equipment maintenance into work instructions for Maintenance Technicians.
• Time management: the ability to manage multiple projects and tasks simultaneously and effectively including planning, scheduling, and organizing. Preferred experience in the Agile Project Management System.
• A continuous improvement mindset: identifying and implementing ways to continuously improve reliability.
• An understanding of lean manufacturing principles, and applying Six Sigma concepts to chemical manufacturing.
• Safety-conscious: the ability to identify potential hazards and take the necessary steps to mitigate them.
• Knowledge of CMMS system and functions
• Knowledge of the regulations and their application to instruments that gather GMP data in a production environment.