Validus Pharmaceuticals Jobs in Usa

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.

Summary of Position

“Quality and safety above everything”. That is the unassailable theme that guides everything that we do, every day. We have an unwavering commitment to quality and the production of safe and effective products. Our science and risk-based compliant quality culture is flexible, innovative, and healthcare oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact our success.

Pherros Biosciences has built a completely new, inspiring, environmentally conscious, and highly automated facility in Deerfield Beach, Florida. This brand-new facility will utilize state of the art technology to engage in parenteral (injectable) pharmaceutical production and packaging operations. This is an exciting and once-in-a-lifetime opportunity to help initiate and operate a new site.

There are numerous positions available for entry, mid-level and supervisory roles in manufacturing operations. The Manufacturing Science Associate will engage in various aspects of pharmaceutical production, including formulation, aseptic filling, visual inspection and secondary packaging, as well as equipment and process implementation activities required to bring the facility into service. Manufacturing Science personnel will be responsible for ensuring continuous supply of our medicines by expertly running the processes, troubleshooting, collaborating cross-functionally, and adhering to our safety first / quality always mindset. Senior and lead Manufacturing Science personnel will coordinate daily activities to meet capacity plans while developing their own as well as the team’s capabilities.

A Manufacturing Science Supervisor is expected to have experience in performing the responsibilities of a Manufacturing Science Associate but also provide daily supervision of areas within manufacturing, maintain responsibility over production timelines and achieve department goals. This includes process planning activities, setting schedules, coordinating interactions and services from other internal and external groups, and assigning daily work tasks. Additional responsibilities will be hiring, development, coaching/leading, and training of manufacturing operators in the assigned area.

Your Diligence Means Our Success

You will be a member of Pherros’ dedicated and highly effective manufacturing operations team. You will evaluate, review and engage in the manufacturing and production of life-changing pharmaceuticals. It is your problem-solving skills that will make us ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

As a Manufacturing Science Associate, you will be part of a team that will execute batch release processes in the course of internally manufactured products. You will ensure drug product manufacturing is carried out in a compliant manner in accordance with current Quality Standards and current Good Manufacturing Practices (cGMPs). Additional specific responsibilities include:

• Engagement in operations on the manufacturing floor ensuring high level of safety, quality, and productivity to maintain production and a reliable supply of products to patients.
• Responsibility for maintaining a safe work environment, exemplifying safe working practices, and being accountable for supporting manufacturing and safety goals.
• Setting a good example through demonstrated knowledge of procedures, compliance with quality systems, and teaching of proper techniques.
• Being a technical leader: Key resource for troubleshooting and functions as the primary point of contact for issue escalation on the shop floor.
• Engaging in manufacturing investigations and implementing corrective and preventative action (“CAPA”) plans.
• Operating the equipment and performing activities as required to meet production schedule.
• Completing and assisting in checking execution documentation (Electronic Batch Record, SAP, Cleaning Logs)
• Driving key departmental objectives including improving safety performance, reducing deviations, improving productivity, and training compliance.
• Supporting Site Leadership to build a diverse and capable site organization by delivering area operational procedures, quality processes and controls.
• Acting as a liaison between operations and support functions.

The responsibilities of a Manufacturing Science Supervisor would include those of a Manufacturing Science Associate, and:

• Ensure production activities comply with cGMP guidelines. Follow all documentation and standard operating procedures. Set priorities, process execution, work assignments, and reprioritize as required.
• Responsibility for providing support to their respective process team.
• Responsibility for cGMP compliance, ensuring that all production equipment is properly validated, and procedures are maintained within validated state.
• Author and revise standard operating procedures and batch records. Review technical reports. Conduct deviation investigations and write process deviation reports.
• Ensure that all production equipment is properly maintained, production areas are inspection ready, and production processes meet quality standards.
• Train personnel in manufacturing process/operations following standard operating procedures and cGMP guidelines.
• Measure and appraise operator performance against job duties, objectives, and goals. Provide accurate and timely feedback. Recommend merit increases, promotions, hires, and terminations.
• Serve as a manufacturing advocate in cross functional meeting and champion company policies to area staff.
• Contribute and adhere to safety, environment, and quality of the Company.
• Communicate safely and maintenance problems., status of operations, and employee-related issues in a timely manner to management.

Qualifications

Must-Have

• We have several levels open for Manufacturing Science Associates and Supervisors which are based on the experience and education you bring.
• Minimum education: Bachelor’s Degree in a scientific discipline such as Biology, Biochemistry, Chemistry or other related discipline, or a High School Diploma/GED equivalent with more than five (5) years of relevant work experience.
• Ability to effectively communicate (electronically, written and verbal)
• Flexibility - the ability to troubleshoot and triage challenges
• Computer proficiency (desktop and tablet software, MS office, quality management system (“QMS”)).
• Must pass a vision exam and be free of color blindness
• Must be equivalent to 20/20 correctable close vision acuity
• Must Pass a “fitness for duty” physical exam
• When in full operation, must have the ability to accommodate longer shifts on a rotating basis when necessary
• Ability to work overtime as required
• Ability to wear safety equipment (glasses, gowns, shoes, gloves, head and face covers, etc.)
• Ability to work and gown in a cleanroom (Grade A-D, Class 100,000 – Class 100; ISO 5 - ISO 8) environment.
• Qualified candidates must be legally authorized to be employed in the United States.
• Pass routine drug-testing suitable for manufacturing personnel.
• Must meet the physical requirements of the job; must have the ability to:
• Lift a minimum of 30 lbs.
• Bend, reach, stretch, climb ladders, and work in tight spaces.
• Stand for long periods.

Nice-to-Have

• (Senior and Lead roles) Leadership and the ability to train / educate team members
• STEM degree or certifications
• Aseptic filling, single use assemblies, isolator technology.
• Automated, semi-automated, and/or manual inspection.
• Knowledge of current Good Manufacturing Practices (CGMPs)
• Experience in operations or manufacturing environments.
• Pharmaceutical, medical device or food processing industries
• Manufacturing Execution Systems and electronic batch release.
• Continuous improvement (Lean, Six Sigma methodologies)
• Highly automated equipment (inspection, packaging, filling, assembly, etc.)
• SAP, Master Control or other QMS, Electronic Batch Records

Other Job Details

 Work Location: On Premises, Full Time

Sunshine Act

Pherros Biosciences reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pherros to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pherros intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pherros that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

EEO & Employment Eligibility

Pherros Biosciences is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pherros Biosciences also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

Manufacturing Science

Pherros Biosciences careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We are looking for new talent to join our global community in order to unearth new innovative therapies that make the world a healthier place.

#wearepherros

MES (PAS-X) Lead Engineer (Biotech/Pharmaceutical)

Location – Wilson, NC

Aztec Technologies is an engineering and consulting firm providing expertise in the

pharmaceutical and biotechnology industries. Aztec Technologies and Aztec Process Automation

are part of Trinity Consultants Company.

Trinity Consultants, Inc., a leading international EHS, life sciences and environment consulting

services with 1500+ engineers worldwide.

Aztec Technologies provides solutions for Manufacturing Applications:

• Process and Facility Automation

• Project Management

• MES

• Data Analytics

With offices across 3 continents, consulting firm with over 20 years of experience within the

biopharmaceutical and pharmaceuticals industries.

The successful candidate will work with a group of engineers involved in the design, automation,

commissioning and start-up of various processes, systems, and facilities. A combination of

strong technical aptitude, automation engineering skills and technical writing are the desired skill

set. This is an outstanding opportunity to join our growing team and to work in the Life Sciences

space that will enhance professional opportunities!

Candidates need to be local or willing to relocate to the areas of operation where we have open

opportunities for immediate hire in the Wilson, NC area:

Key Responsibilities:

• Own MES configuration management for PAS-X, including:
• Manufacturing Batch Records (MBRs)
• Material management
• Equipment and timer management
• Label management
• Lead MES design, configuration, testing, and troubleshooting
• Act as technical interface between MES, DCS (DeltaV), ERP, LIMS, and other shop-floor systems
• Support MBR migration from a legacy site
• Ensure alignment with site and global MES standards
• Support risk assessments and GMP compliance activities
• Provide hands-on troubleshooting and technical support during execution
• Develop and maintain MES technical documentation
• Collaborate closely with IT, Manufacturing, Quality, and Engineering teams

Required Qualifications

• 8+ years experience in pharmaceutical or biopharmaceutical manufacturing environments
• Strong hands-on experience with MES platforms, preferably Werum PAS-X
• Proven experience with MBR design and execution
• Solid understanding of GMP manufacturing processes
• Experience integrating MES with DCS (DeltaV) and enterprise systems
• Strong analytical, troubleshooting, and problem-solving skills
• Bachelor’s degree in Engineering, IT, Science, or related discipline

Preferred / Nice-to-Have Skills

• Programming experience: .NET, SQL / PL-SQL, Java
• Experience with OPC servers/clients
• Knowledge of 21 CFR Part 11 and EU GMP Annex 11
• Process knowledge across:
• Upstream
• Downstream
• Bioprocess support functions
• Ability to communicate effectively with both technical and non-technical stakeholders

Ideal Candidate Profile:

• Senior-level PAS-X MES SME
• Strong on-site presence and ownership mindset
• Comfortable operating as Owner’s Rep, not a junior configurator
• Deep pharma/biotech automation background
• Able to bridge Manufacturing, IT, Automation, and Quality

Pharmaceutical Sales Representative – Veterinary - Flex Time (12 days/mo)

Promoveo Health, a leading Pharmaceutical Sales recruiting, and contract sales company has an outstanding position representing one of our strategic clients. Our client is a rapidly growing organization with a very strong presence in the Veterinary Medicine field.

This is a position where you will be a W2 employee of Promoveo Health.

The Veterinary Sales Representative will be responsible for revenue growth within your specified geographic region. You will be accountable for a sales revenue plan in the clinical (office based) markets. This role requires strong account management and selling skills, as you will be the selling interface between the accounts and the company.

The ideal candidate will have:

· 5+ years of Veterinary Pharmaceutical Sales either on the Pharmaceutical or Distributor side

· Clinical experience calling on Veterinary Practices in this market

· Experience calling on and existing relationships with Vets in the area

· Excellent interpersonal, communication, teaching and negotiation skills

· BS Degree in related discipline

Job Expectations:

·Part time position with high management visibility and performance expectations.

· Travel – You will be home every night- no overnight travel is required!

EOE STATEMENT

• We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.

Overview

The VP, Account Director leads senior client relationships and drives strategic growth across key healthcare and pharmaceutical accounts within a healthcare advertising environment. This role leads integrated teams to deliver high-impact marketing initiatives while ensuring alignment with client business objectives and regulatory requirements.

The VP, Account Director provides strategic oversight, mentors account teams, and collaborates closely with cross-functional partners to ensure the successful execution of integrated campaigns across multiple channels. This leader plays a critical role in driving client satisfaction, operational excellence, and business growth.

This position is based in New York City and follows a hybrid work model, requiring three days in the office (Tuesday–Thursday).

Key Responsibilities

Client & Account Leadership

• Serve as the senior strategic partner for key healthcare and pharmaceutical clients, building trusted relationships and providing proactive counsel.
• Lead account teams to deliver work that aligns with client objectives, timelines, and quality expectations.
• Champion brand strategy and ensure consistent execution across campaigns and deliverables.

Strategic Direction & Growth

• Translate client business goals into integrated marketing strategies across multiple channels, including digital, social, print, and medical communications.
• Identify opportunities for organic growth and support new business development efforts and pitches.
• Lead strategic planning discussions and contribute to quarterly business reviews.

Team Leadership & Collaboration

• Lead and mentor account team members, fostering a collaborative, high-performing culture.
• Partner with creative, strategy, medical, digital, and project management teams to ensure seamless campaign execution.
• Provide clear strategic direction and guidance to internal teams.

Financial & Operational Management

• Oversee account financial performance including forecasting, SOW development, and budget management.
• Ensure accounts operate efficiently while maintaining profitability and strong client satisfaction.
• Monitor project scope, timelines, and resources to ensure successful delivery across work streams.

Compliance & Industry Expertise

• Ensure all work adheres to healthcare industry regulations, including FDA and MLR requirements.
• Maintain a strong understanding of the pharmaceutical advertising landscape and evolving industry trends.

Qualifications

• 10–15+ years of healthcare or pharmaceutical advertising experience, with a proven track record leading integrated accounts.
• Demonstrated ability to build strong client relationships and deliver strategic marketing programs in regulated healthcare environments.
• Proven leadership experience managing cross-functional teams and mentoring account staff.
• Strong financial acumen with experience managing account budgets, forecasting, and profitability.
• Excellent communication and presentation skills with the ability to influence senior clients and internal stakeholders.
• Experience in ophthalmology and/or rare disease strongly preferred.
• Bachelor’s degree required.

Equal Opportunity Employer

Moon Rabbit embraces and celebrates diversity, inclusivity, and equal opportunity. We are committed to building a team that reflects a wide range of backgrounds, perspectives, and experiences. As a global agency serving global clients, we believe that a more inclusive workplace enables us to produce stronger, more impactful work together.

Moon Rabbit is proud to be an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, gender identity or expression, sexual orientation, national origin, age, disability, veteran status, or any other protected characteristic under applicable law.

Summary:

The Head of Production (Sterile Injectables) is responsible for providing strategic and operational leadership for all aspects of sterile manufacturing operations. This role ensures compliance with cGMP regulations, drives operational excellence, and leads high-performing teams to achieve manufacturing objectives in a regulated environment.

Responsibilities:

• Direct and oversee all sterile manufacturing operations, including component preparation, formulation, compounding, aseptic filling, visual inspection, and packaging.
• Develop and implement production strategies to achieve manufacturing goals, supply commitments, and performance targets.
• Ensure all manufacturing activities adhere to cGMP regulations, internal quality systems, and regulatory requirements for sterile drug products.
• Maintain a continuous state of audit readiness and support regulatory inspections, internal audits, and customer audits.
• Lead and manage investigations, deviations, CAPAs, and change control processes impacting production operations.
• Establish, monitor, and report on key performance indicators (KPIs) related to safety, quality, delivery, and productivity to drive accountability and improvement.
• Champion operational excellence initiatives to enhance manufacturing efficiency, reduce waste, and improve process reliability.
• Build, develop, and lead high-performing production teams, fostering a culture of compliance, safety, and continuous improvement.

Qualifications:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related scientific field required; Master’s degree preferred.
• 8–15 years of progressive experience in pharmaceutical manufacturing operations within a regulated cGMP environment.
• 5–12 years of leadership experience in sterile or aseptic pharmaceutical manufacturing settings.
• Proven experience overseeing operations such as formulation, compounding, aseptic filling, visual inspection, and/or packaging of pharmaceuticals.
• Strong knowledge of FDA cGMP regulations and regulatory expectations for sterile drug product manufacturing.
• Experience supporting regulatory inspections and maintaining audit-ready operations.
• Demonstrated ability to lead investigations, manage deviations, CAPAs, and change control activities.
• Proven leadership skills with experience developing and managing production teams in regulated environments.

Kelly® Science & Clinical is seeking a Process Engineering Manager for a direct hire opportunity with one of our clients, a leading small molecule CDMO at their Colorado Springs, CO facility. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Workplace: Onsite in Colorado Springs, CO

Position Title: Process Engineering Manager, Oral Dosage Forms

Position Type: Direct hire

Salary: $125,000-140,000

Are you ready to drive innovation and success in pharmaceutical manufacturing? We are seeking a dynamic Principal Investigator to serve as a technical authority in process development, scale-up, and technology transfer. If you thrive in collaborative, fast-paced environments and are passionate about advancing life-changing therapies, this is your opportunity to make a significant impact.

Responsibilities

Strategic Process Development & Scale-Up

• Spearhead the development and scale-up of robust, scalable manufacturing processes across a wide spectrum of drug products
• Design and lead process characterization and optimization studies, defining critical process parameters and proven acceptable ranges
• Champion Quality by Design (QbD) strategies and advanced statistical methodologies, ensuring seamless progression from laboratory concepts to pilot-scale execution

Technology Transfer Leadership

• Serve as the technical lead for all technology transfer activities, bridging R&D, global manufacturing sites, and client partners
• Develop and implement comprehensive transfer protocols and process equivalence strategies to ensure flawless execution
• Lead high-performing, cross-functional teams through knowledge transfer, process mapping, and documentation best practices

Pilot Plant & cGMP Operations Management

• Oversee cGMP-compliant pilot plant operations, supporting clinical and commercial production, validation, and process improvement
• Drive continuous improvement projects—maximizing efficiency, quality, and yield
• Provide expert troubleshooting and manage deviations, ensuring on-time project delivery

Capital Projects & Facility Optimization

• Lead equipment qualification and validation for cutting-edge process installations
• Direct facility expansion and modification projects to support innovation and new technology implementation
• Optimize facility workflows to enhance operational excellence and scalability

Quality Assurance & Regulatory Compliance

• Ensure strict adherence to cGMP (21 CFR 210/211) and data integrity (21 CFR 11) regulations
• Develop and execute robust process validation strategies in accordance with global regulatory standards
• Lead investigations, implement corrective/preventive actions, and maintain perpetual audit readiness

Project Management & Client Engagement

• Manage multiple, high-profile client technology transfer programs—delivering on time and within budget
• Serve as the primary technical liaison for clients, providing strategic insight and technical guidance
• Develop detailed project plans, risk assessments, and contingency strategies to de-risk tech transfer activities
• Mentor cross-functional teams, fostering a culture of excellence and innovation

Qualifications

Education:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related field; advanced degree (MS/PhD) preferred

Experience:

• 8+ years’ experience (Bachelor’s), 5+ years (MS), or 3+ years (PhD) in pharmaceutical process development, technology transfer, and scale-up within a CDMO or CRO environment
• Demonstrated success managing complex, cross-functional projects in a regulated setting

Technical Mastery

• Deep expertise in pharmaceutical process engineering, manufacturing technologies, process validation, and equipment qualification
• Comprehensive understanding of cGMP, quality systems, and regulatory compliance
• Proven skills in process automation, risk management, and project execution

Leadership & Collaboration

• Recognized leadership in guiding technical teams and cross-functional project groups
• Outstanding client relationship management and communication abilities
• Strategic thinker with a results-driven mentality, adept at navigating complex challenges and inspiring teams

Why Join Us?

• Work alongside industry leaders and innovators
• Participate in high-impact projects accelerating life-saving therapies to market
• Competitive salary, comprehensive benefits, and opportunities for continued professional growth

What happens next:

Once you apply, you’ll proceed to the next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

SUMMARY

Experienced HR leader needed to oversee full-scope human resources functions within a brand pharmaceutical environment. This role supports organizational growth by managing recruitment, employee relations, compliance, performance processes, and policy development. The position offers strong professional visibility, the chance to influence HR strategy, and growth potential for someone advancing toward higher-level HR leadership.

Must have brand pharmaceutical industry experience.

RESPONSIBILITIES

• Ensure HR policies and procedures stay current, compliant, and aligned with employment regulations.

• Guide staffing strategies, recruitment activity, and talent acquisition processes to support organizational goals.

• Develop, implement, and refresh HR programs and guidelines, ensuring managers and employees are properly trained.

• Oversee end-to-end hiring operations, including role approvals, applicant review, agency coordination, offer processes, onboarding, and progress tracking.

• Partner on safety, environmental, and security program initiatives as needed.

• Support HR budgeting, workforce planning, talent development, and progression planning efforts.

• Manage employee relations matters such as investigations, corrective actions, performance issues, recognition programs, leave situations, and separation activities.

• Maintain updated organizational charts and accurate job profiles across all business units.

• Assist with benefits program administration, evaluation of vendors, and annual plan reviews.

• Participate in internal and external audits to ensure compliance.

• Review compensation and benefit structures to ensure competitiveness and help attract and retain top talent.

QUALIFICATIONS

• Bachelor’s degree in HR or related field, or equivalent progressive HR experience.

• Minimum five years of HR experience with demonstrated leadership responsibilities.

• Required: prior experience in a brand pharmaceutical organization.

• Strong understanding of HR laws, regulations, and industry best practices.

• Clear communication abilities, both written and verbal.

• Strong interpersonal and leadership skills with the ability to collaborate across all levels.

• Sound judgment and analytical skills with the ability to problem-solve effectively.

• Excellent time-management and organizational skills with the ability to manage multiple priorities.

• Proficiency with Microsoft Office and HR information systems.

• Ability to maintain confidentiality and work independently.

BENEFITS

• Hybrid work model with select remote days.

• Opportunity to influence HR strategy in a growing pharmaceutical environment.

• High-level exposure and partnership with senior leadership.

• Clear long-term growth potential within human resources.

Location: On-site in Upstate NY (Relocation from Canada welcome!)

Please note: We are only considering W2 candidates at this time. Applications from third-party vendors or C2C arrangements will not be considered.

ADVENT Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. Headquartered near San Francisco, California, and with operations in the Eastern and Western US, Canada and Singapore, our company is involved in almost every facet of global pharmaceutical and biotechnology facility design and process engineering and quality system projects.

ADVENT's services include process engineering, automation engineering, project engineering, facility/system design, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufacturing companies.

The successful candidate will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

This is an outstanding opportunity to join our growing team!

Full-Time | Onsite

About the Role:

We are seeking a detail-oriented and technically proficient Process Engineer who will work with a group of engineers involved in the design, automation, commissioning and start-up of various processes, systems and facilities. A combination of strong technical aptitude, automation engineering skills and technical writing are the desired skill set.

Responsibilities

• Work with Upstream equipment
• Fermentation
• Process optimization
• Process scale-up or scale-down studies
• Commissioning and Qualification
• Protocol generation and execution
• Data analysis
• Report writing
• Author SOPs
• Great communication skills (presenting, and writing)
• Protein expression/purification
• GxP (GDP, GLP, or GMP a major asset)

Minimum Requirements

• Bachelor’s or master’s degree in Biochemistry, Biology, Mechanical Engineering, Chemical Engineering, Biochemical Engineering, or related discipline.
• Required: 3+ years of experience in the biotech-pharmaceutical academic or industrial environment.
• Bioprocess experience preferred
• Fill finish experience preferred
• Basic knowledge of upstream/downstream drug substance manufacturing.
• Basic knowledge of regulatory compliance inclusive of cGMP, OSHA, EPA, FDA regulations. Familiarity with ICH guidelines and EMA regulations is a plus.
• Basic technical writing with proficiency in Excel, PowerPoint, Visio, Word, Sharepoint, etc. in addition to experience working within shared work environments.
• Demonstrated experience with manufacturing processes and equipment such as CIP systems, bioreactors, filtration skids, chromatography and lyophilization equipment.
• Basic knowledge of the Commissioning and Qualification.
• Travel within USA as needed for the projects.

Perks & Benefits:

• Competitive salary
• Full health, dental, vision, and retirement benefits
• Tuition reimbursement, PTO, and more

Job Title - Training Coordinator - Pharma Operations

Location - Easton PA

The Training Coordinator is responsible for the strategic coordination, compliance oversight, and administrative management of the employee development program within pharmaceutical operations or GMP‑regulated training. The Training Coordinator role require candidates with GMP‑regulated experience in a pharmaceutical setting. This role ensures training activities are aligned with operational demands, properly resourced, and fully compliant with company policies, OSHA standards, client requirements, and regulatory expectations. The training coordinator will maintain an audit-ready workforce ensuring employees are compliant and up to date on training records.

MUST HAVES -

• Direct experience maintaining training records in an LMS - need for accurate, audit‑ready training documentation.
• Demonstrated history of developing and delivering internal training in pharma & life sciences, as well as supporting SOP and job aid updates in regulated environments.
• Extensive experience in highly regulated FDA/GMP environments, supporting complaint management, audits, and compliance activities.
• Strong reporting skills, including trending, KPI analysis, and preparing audit‑ready materials.
• experience in warehouse‑specific training logistics, such as WMS familiarity, multi‑shift training calendars, and training around warehouse equipment certification (e.g., PIT/Forklift).
• experience with OJT verification workflows or tracking certifications/expiration dates tied to warehouse operations.
• troubleshooting classroom technology (e.g., handheld scanners or tablets used in training).

Education & Experience

• High school diploma or equivalent
• 2+ years of administrative and training coordinator experience, specifically within a background related to pharmaceutical operations or GMP‑regulated training. candidates with GMP‑regulated experience in a pharmaceutical setting.

Responsibilities:

• Develop and maintain comprehensive training schedules across all warehouse departments.
• Support facilitation of training on company policies, SOPs, safety standards, and operational systems (e.g., LMS, WMS/C3).
• Partner with warehouse leadership to ensure structured training programs are consistently executed for new hires and existing associates.

Logistics & Scheduling

• Training calendar coordination: Manage the master training calendar across 1st, 2nd, and 3rd shifts, ensuring training sessions do not disrupt peak shipping and receiving windows.
• Onboarding Logistics: Coordinate onboarding training for new associates, including safety gear (PPE) distribution, badge access, and classroom setup.
• Equipment Certification: Schedule and track practical evaluations and certifications for Powered Industrial Trucks (PIT) and other applicable equipment, ensuring only authorized personnel operate machinery.

Administrative & LMS Management

• Record Integrity: Maintain the training program within the Quality Management System and any required physical training documentation, ensuring every associate has a complete, accurate, and audit-ready training profile.
• Compliance Tracking: Proactively monitor certification and qualification expiration dates (e.g., PIT/Forklift, HazMat, Safety protocols) to prevent compliance gaps or operational disruption.
• SOP Document Control: Coordinate distribution and version control of Standard Operating Procedures (SOPs) to ensure associates are trained on current, approved processes.

Reporting & Auditing

• Audit Support: Prepare and present training documentation during internal audits, client audits, OSHA inspections, and regulatory reviews.
• Productivity Reporting: Generate reports on training completion rates and "Time to Productivity" for new hires to help Operations plan for peak seasons.
• OJT Verification: Collect, verify, and maintain On-the-Job Training (OJT) documentation to confirm hands-on competency validation by authorized supervisors.

Technical Skills:

• Advanced proficiency in Microsoft Office (Excel is critical for tracking metrics). Experience with Quality Management Systems and/or Warehouse Management Systems is a plus.
• Organization: Exceptional organizational skills with a "zero-error" approach to data entry, understanding that a missing record can lead to a regulatory finding.
• Communication: Ability to communicate clearly within a diverse workforce, from entry-level associates to senior facility management.
• Experience with "Train-the-Trainer" models in a manual labor setting.
• Ability to troubleshoot basic classroom technology (tablets, hand-held scanners used for training).
• Effective analytical, problem solving and decision-making skills (can gather and analyze data and information and draw conclusions). Able to think logically and analytically.
• Able to prioritize, organize tasks and time, and follow up. Performs responsibilities efficiently and timely. Able to balance multiple requests and meet deadlines.
• Able to work well in a team environment and as part of a team.
• Demonstrates ability to effectively lead a team to successful completion of a project.
• Knowledge of FDA and CFR requirements surrounding training