Basys Processing Reviews Jobs in Usa

At STERIS, we are dedicated to creating a healthier and safer world through innovative healthcare and life science solutions. As industry experts in sterile processing, our teams process over 150 million instruments annually for our customers. We are looking for a dynamic and experienced Senior Manager, Sterile Processing to join our team and lead our facility's production and quality efforts. As a Senior Manager Sterile Processing, you'll oversee production and quality performance across outsourced facilities and customer accounts. You'll be the driving force behind ensuring customer satisfaction by proactively managing daily operations, meeting contractual obligations, and upholding the highest standards in sterile processing. You'll provide on-site support, training, and strategic communication to both internal teams and client facility staff. You'll ensure strict compliance with regulatory standards from the Department of Health, TJC, DNV, OSHA, CDC, AAMI, and AORN. Leveraging your expertise in process improvement, you'll lead impactful initiatives using STERIS Process Improvement (PI) modules, driving efficiency, safety, and service excellence across all operations.

This is an onsite role based in Chicago, IL.

What you'll do as a Senior Manager Sterile Processing:

Lead and inspire a high-performing leadership team to deliver exceptional day-to-day service that meets customer needs, contractual obligations, and business goals.

Build and maintain strong relationships with customers at all levels, including executive leadership, ensuring satisfaction through regular KPI reviews, pulse checks, and bi-annual business reviews.

Proactively resolve customer issues by identifying root causes, implementing corrective action plans, and tracking measurable outcomes.

Collaborate with STERIS Business Development and internal teams to identify growth opportunities, support contract changes, and expand service offerings.

Ensure full compliance with all regulatory standards (DOH, TJC, DNV, OSHA, CDC, AAMI, AORN) and facility policies across all operations.

Oversee staffing strategies, aligning resources with fluctuating demand and ensuring leadership is equipped to do the same.

Foster a culture of employee engagement, retention, and safety through ongoing communication, training, and development.

Manage recruitment, onboarding, coaching, and performance management to build a skilled and motivated team.

Drive continuous improvement by leading process improvement initiatives using STERIS PI modules and coaching others in PI methodology.

Ensure accurate and timely completion of all administrative functions, including documentation, billing, inventories, and time records.

Effectively manage P&L responsibilities, ensuring financial targets are met while delivering high-quality service.

Implement new policies, procedures, and services in alignment with contracts and STERIS standards to enhance customer experience.

Collaborate across STERIS operations, service, and finance teams to support business objectives, manage invoicing, and ensure accurate financial reporting.

The Experience, Skills, and Abilities Needed:

High School Diploma

10 years of experience in Sterile Processing and 5 years of Sterile Processing leadership

CRCST or CBSPD Certification. If not certified at point of hire, certification must be obtained within 12 months of hire.

Must be able to be compliant with hospital/customer credentialing requirements.

Preferred Experience:

Bachelor's degree

Leadership experience supporting a minimum of 20 Operating Rooms

Pay range for this opportunity is $113,900.00 - $147,400.00. This position is eligible for bonus participation.

Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.

STERIS offers a comprehensive and competitive benefits portfolio.

STERIS is an Equal Opportunity Employer. We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.

The WeCARE Physician is the role of Review Physician supports the Medical Director in the implementation of standard operation policies and procedures to ensure that UBA WeCARE complies with all New York City's HRA contractual requirements.

Key Responsibilities are:-To conduct medical reviews of Clinical Assessments/Clinical Reassessments for finalization, complete Wellness Plans dispositions for UBA WeCARE clients, and act as a clinical support for UBA WeCARE staff in the fulfillment of funder, (NYC HRA), contracted goals.

-Conduct medical reviews of Clinical Assessments completed by Qualified Health Professionals -Displays knowledge of medical conditions and SSA disability criteria.-Review prior WeCARE documentation, documentation provided by the client, prior and current Clinical Assessment/Clinical Reassessments, previous Medical Evaluation and Substance Use Assessment (when indicated).-Review, address, and correct any inconsistencies in the history obtained by the QHP-Order and review additional specialty assessments as indicated -Review and update Reasonable Accommodations and work limitations.-Determine appropriate medical diagnoses.

Assess the stability of client's medical issues.-Obtain medical documentation from EPIC, PSYCKES, and Bronx RHIO.-Enter information/complete appropriate forms in HRA (funder) database (SEAMS).

-Complete off-line/paper when medical record system SEAMS, is not functioning completely or is partially working.

-Ensure all off-line paper documents and medical records obtained from outside sources are scanned into SEAMS within 24 hours.

-Review the SSA sequential evaluation process conducted by the QHP to ensure accuracy.-Review provided wellness documentation from treatment providers -Check for medical documentation in EPIC, PSYCKES, and Bronx RHIO-Update and review reasonable accommodations and limitations-Ensure the FCO is correct and that the FCO justification contains relevant information -Review Wellness extensions with Medical Director and provide summary justifications for same-Able to assist and motivate clients to comply with WeCARE process.

Able to assist clients to access services to reduce barriers to compliance with WeCARE appointments.

-Knowledge of medical and behavioral health diagnoses.-Knowledge of various software systems including SEAMS, EPIC, PSYCKES, Bronx RHIO, etc.

-Possess strong computer skills with knowledge of Microsoft Office applications.

-Knowledge of SSA disability application process is preferred.Experience with NYC HRA preferred.Two years of professional experience in medical or clinical practice.Complete Wellness Enhancement Forms as indicated for Wellness track clients Medical and computer software (SEAMS, EPIC) and medical depository information databases (example PSYCKES, Bronx RHIO)In addition to a competitive salary of $180,000-220,000, we offer LTD, STD, paid malpractice, health, dental, vision and a 403(b).

Interested candidates should have a current unrestricted NYS Doctor of Medicine license to practice and American Board of Medical Specialties or American Osteopathic Association Board Certification and send an updated CV to Senior Recruiter, Desiree Aulet at Montefiore is an equal employment opportunity employer.

Montefiore will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.

Job Title: Director Process Development and Manufacturing, CMC

Department: CMC

Reports to: Chief Technical Officer

About the Company:  

Opus Genetics is committed to building an innovative, efficient and sustainable science based and commercial ophthalmic biopharmaceutical company leading the development of transformative gene therapies for the treatment of inherited retinal diseases (IRDs) and therapies to treat patients with other retinal and refractive disorders.

Job Summary: 

The Director of Process Development and Manufacturing will be the technical lead for development and manufacturing of assigned assets within the Opus gene therapy programs focusing on technical transfer and process development and execution supporting product development and manufacturing to achieve company goals and strategies. This includes working collaboratively with external partners (i.e. CDMOs, contract labs, suppliers) to develop technical studies, analyze complex data, make data driven decisions, and author, review, and approve technical and regulatory documents. The ideal candidate will have a deep technical understanding of AAV gene therapy upstream and downstream development and process optimization.  This role will directly interact with the CDMO/contract partners and be responsible for building and maintaining excellent working relationships. Knowledge of manufacturing platforms, consistent with AAV technology, at scales ranging from process development through GMP and PPQ activities. The candidate will be hands-on and expected to provide content to all these areas. 

Duties/Responsibilities: 

·      Work with Opus CDMO/contract manufacturing and laboratory partners to develop a phase appropriate robust manufacturing program to support the process development and engineering of pre commercial and commercial cGMP material to support pre-clinical studies, clinical trials, and commercial supply. 

·      Support, author, and review/approve manufacturing plans and documentation including technical transfer, batch records and documentation, product specifications, stability programs, bridging and comparability studies, and other reports utilizing phase appropriate QbD best practices.

·      Support, author, and review/approve manufacturing documentation including testing records, certificates of testing/analysis, campaign summary reports, investigations, etc. 

·      Support, author, and review/approve regulatory documentation including pINDs, INDs, agency responses, CMC meeting requests and briefing packages, and BLAs.   

·      Ensure proper reference standard material is in place, tested, and released for each product. Lead technology transfer between sites. 

·      Ensure regulatory requirements are in place to support manufacturing campaigns with respect to Master Cell Banks, Plasmids, Drug Substances, Drug Products, and Diluents, to prevent developmental delays and or interruptions to clinical programs or regulatory filings.

·      Perform the role of person in plant as needed at the Opus CDMO/contract manufacturing partner’s sites. Act as the CMC expert during audits and interactions with regulatory agencies. 

·      Manage work to project plans for multiple gene therapy programs in the preclinical, pre-IND, IND/clinical, and commercial stages. 

·      Identify and lead the resolution of operational and functional level challenges, work with program and/or function managers to escalate issues to senior management.

·       Hands on resolution to issues/content generation. Design effective and high-quality presentations and progress reports, as requested.

Supervisory Responsibilities: 

·      None 

Education and Experience: 

·      Master’s degree (minimum) from an accredited institution in a science or health-related field with minimum of 7-10 years of experience in the pharmaceutical or biotechnology industry. Ophthalmology experience is preferred.

·      Additionally, a minimum of 5 years of direct manufacturing experience for biopharmaceuticals. Preference will be given for direct AAV gene therapy experience. Previous CDMO/contract lab experience also preferred.

·      Experience designing and executing technical transfer and scale up campaigns and associated documentation.

·      Experience in writing and reviewing regulatory submissions including pINDs, INDs, Meeting Requests/Briefing Packages, Annual Report/DSUR’s, and BLAs. 

·      Experience with FDA and/or other regulatory agency requirements and interactions.

·      Strong skill set in interacting with multidisciplinary teams for preclinical and clinical development. Clear understanding of the drug development process with experience in multiple phases.

·      Experience with Orphan/Rare Disease programs, and/or Fast Track/Breakthrough Therapy is a plus.

·      Demonstrated leadership skills and ability to influence across all levels of a cross-functional team without direct managerial authority. Experience in risk assessment, negotiation, and problem solving/mitigation.

·      Outstanding interpersonal skills, ability to communicate effectively in both oral and written form, with effective time management skills needed to manage multiple ongoing projects simultaneously.

·      Demonstrated advanced computer software proficiency (Word, Excel, Smartsheet’s, PowerPoint, etc.).  

Physical Requirements:  

·      Ability to travel 20% of time

·      Ability to work in laboratory settings/situations

·      Prolonged periods sitting at a desk and working on a computer. 

·      Must be able to lift up to 15 pounds at times. 

Location:

This position is currently based in the Durham North Carolina area; Hybrid/ remote options considered.

 Salary Range:

$190,000-210,000

The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor. 

Opus Genetics is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. 

This is more than just a modeling job—it is your gateway to becoming a specialist in Advanced Semiconductor Chemical & Gas Delivery Systems. While you contribute your 1-2 years of site experience, we will provide the platform for you to master the complex logic behind high-purity piping, automated delivery, and international safety codes. You will transition from "building models" to "designing critical infrastructure" for the world's leading tech fabs.

General Responsibilities:

• Architectural & System Modeling: Develop and prepare high-precision 3D architectural and MEP designs using Revit and AutoCAD.
• Integrated Coordination: Collaborate with engineers and PMs to ensure design accuracy, ensuring all process requirements are met.
• Design Evolution: Proactively review and update models to reflect real-time design changes and field adjustments.
• Conflict Resolution: Perform Clash Detection and lead the reporting/solving of spatial discrepancies to ensure a seamless build.
• Team Leadership: Participate in technical meetings and provide progress updates to stakeholders.

Specialized Knowledge & Growth

• P&ID Translation: Read and interpret P&IDs/PFDs (Piping and Instrumentation Diagrams) to align 3D models with functional process logic.
• Subcontractor Management: Act as the technical bridge, communicating 3D model requirements to subcontractors for onsite coordination.
• Advanced System Learning: Gain deep-dive knowledge in Chemical Delivery Systems (CDS) and Gas Delivery Systems (BDS) specifically for advanced semiconductor nodes.

Qualification:

• Minimum Associate Degree in a related engineering or architectural field.

Must Have:

• Software Mastery: Proficiency in BIM software (Revit) and AutoCAD.
• Industry Experience: 1–2 years of experience in design-related work, preferably within the semiconductor or high-tech

Nice to Have:

• Process Piping: Experience with specialized materials like CPVC/PFA, SUS/PFA, and SUS/SUS piping design.
• Electrical & Control: Knowledge of Power/Control system design, including Tray, Conduit, and RSG layouts.
• Standards & Codes: Familiarity with NEC or ASME codes is a significant plus.
• Project Context: Previous involvement in Gas/Chemical-related projects.

What You Will Learn & Achieve

• Semiconductor Expertise: Master the design logic of supply systems that power the world's most advanced chip manufacturing.
• Professional Elevation: Move beyond 3D modeling into Digital Engineering, learning how to manage complex data within a BIM environment.
• Cross-Domain Skills: Gain exposure to mechanical, chemical, and electrical integration, making you a highly versatile asset in the global semiconductor talent market.

What Makes a Honda, is Who makes a Honda

Honda has a clear vision for the future, and it’s a joyful one. We are looking for individuals with the skills, courage, persistence, and dreams that will help us reach our future-focused goals. At our core is innovation. Honda is constantly innovating and developing solutions to drive our business with record success. We strive to be a company that serves as a source of “power” that supports people around the world who are trying to do things based on their own initiative and that helps people expand their own potential. To this end, Honda strives to realize “the joy and freedom of mobility” by developing new technologies and an innovative approach to achieve a “zero environmental footprint.”

We are looking for qualified individuals with diverse backgrounds, experiences, continuous improvement values, and a strong work ethic to join our team.

If your goals and values align with Honda’s, we want you to join our team to Bring the Future!

Job Purpose

The Additive Manufacturing (AM) Process Lead will drive the development, qualification, and continuous improvement of metal LPBF (Laser Powder Bed Fusion) processes for aero‑engine components.

This position requires strong hands‑on expertise with LPBF equipment, including machine operation, calibration, tuning, and maintenance, as well as experience in parameter development and process optimization.

The Process Lead will support supplier readiness, evaluate/develop Machine/Process Qualification activities, and establish production‑ready AM and post‑processing workflows.

The role requires close coordination with Design, Materials and Quality to meet the milestones for component development, qualification, certification, and future production.

Keywords: LPBF, process development DOE, machine calibration, supplier development, qualification/certification/production, cross‑functional contribution, problem solving

Key Accountabilities

[AM Process Development & Execution]

• Lead LPBF build setup, execution, and troubleshooting; maintain detailed and traceable build records.
• Perform machine calibration and tuning, including laser alignment, scan field or beam offset adjustments, Z‑axis checks, and recoater verification.
• Develop and refine LPBF parameter sets using DOE and data‑driven approaches.
• Conduct engineering tests and verification builds using the PDCA cycle.
• Support in‑situ monitoring/simulation data interpretation and correlation with part quality.
• Analyse build failures systematically and implement corrective/preventive actions.
• Operate auxiliary equipment such as EDM, heat treatment furnace, CNC machines, and metrology equipment as needed.
• Review 2D and/or 3D models and provide manufacturability feedback to design engineers in the U.S. (US) and Japan (JP).
• Oversee powder management, powder characterization, and lot traceability.
• Maintain equipment health through preventive maintenance and performance monitoring.
• Create and maintain Process Control Documents (PCDs) such as quality control plans, work instructions etc.
• Collaborate with regulatory and industrial groups when required (e.g., FAA/EASA, ASTM, SAE, America Makes).

[IHM & Outsourcing Supplier Qualification]

• Adhere to AMS 7003 and AMS 7032 specifications for execution and documentation.
• Lead technical evaluations for LPBF and post‑processing capabilities.
• Support the creation and execution of qualification tests, including parameter window establishment and production readiness assessments.
• Coordinate with Design, Materials, and Quality teams to align processes with aviation industry standards.
• Support supplier onboarding and capability development for future production phases.
• Establish process flows and data structures within ERP/MES systems to support qualified and production‑ready processes.

[Others]

• Maintain a clean, safe, and organized AM working environment.
• Work effectively in an international, cross‑functional engineering environment.
• Participate in training, conferences, and technical exchanges as needed.

Qualifications, Experience, and Skills

Minimum Educational Qualifications:

Bachelor’s degree in Mechanical Engineering, Materials Engineering, Aerospace Engineering, Manufacturing Engineering, or equivalent experience.

Minimum Experience:

Must‑Have Skills

• Hands‑on experience (5+ years) with metal LPBF EOS M400-4 or M290 systems, including build setup, operation, powder handling, and troubleshooting.
• Capability to perform LPBF machine tuning (e.g., optical‑related adjustments such as laser alignment, scan‑field/beam‑offset checks, Z‑axis/recoater verification).
• LPBF parameter development, including DOE‑based optimization (e.g., diagnosing root causes related to laser performance, recoating behavior, powder spreading, thermal distortion, scan strategy).

Preferred but not required (Want):

• Powder quality evaluation and NDT/CT/inspection workflows.
• In‑situ monitoring/process simulation or thermal/optical process data.
• Participating in equipment installation, SAT/FAT, or facility preparation.
• Supporting supplier technical assessments or capability reviews.

Other Job-Specific Skills:

Must‑Have Skills

• Ability to maintain a safe, clean, and controlled AM work environment.
• Ability to interpret and create engineering drawings, including GD&T understanding, tolerances, and manufacturability considerations.
• Strong practical engineering skills and the ability to independently perform hands‑on work on LPBF equipment and related tools.
• Solid analytical skills to support test planning, data interpretation, and preparation of technical reports.
• Ability to organize and execute assigned project tasks, track schedules, and contribute to issue resolution in cross‑functional teams.
• Ability to write clear, structured engineering documents and communicate technical content effectively.
• Ability to manage multiple tasks, maintain detailed records, and ensure process traceability.
• Effective communication and collaboration across international and cross‑functional teams.

Preferred but not required (Want):

• Knowledge of aerospace quality frameworks or certification concepts:
• AS9100
• FAA Certification / AC35.15-3
• Familiarity with AM build preparation software.
• Familiarity with internal calibration and verification procedures for AM machine.
• Experience with Material Qualification or Part Qualification.

Working Conditions

• Ability to lift >25lbs.
• Respiratory PPE is required for metal powder handling.
• Some domestic and international travel is expected for training and conferences.
• Frequent evening remote meetings with Japan and Europe is expected.
• OT may be allowed ~5 hrs/week.

What differentiates Honda and make us an employer of choice?

Total Rewards:

• Competitive Base Wages (pay will be based on several variables that include, but not limited to geographic location, work experience, etc.)
• Paid Overtime
• Regional Bonus (when applicable)
• Industry-leading Benefit Plans (Medical, Dental, Vision, Rx)
• Paid time off, including vacation, holidays, shutdown
• Company Paid Short-Term and Long-Term Disability
• 401K Plan with company match + additional contribution

Career Growth:

• Advancement Opportunities
• Career Mobility
• Education Reimbursement for Continued Learning
• Training and Development Programs

Additional Offerings:

• Lifestyle Account
• Childcare Reimbursement Account
• Tuition Assistance & Student Loan Repayment
• Elder Care Support
• Wellbeing Program
• Community Service and Engagement Programs
• Product Programs

Honda is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, creed, religion, national origin, sex, sexual orientation, gender identity and expression, age, disability, veteran status, or any other protected factor.

TekPro is partnered with a precision machining manufacturer in the Chicago area that is looking to add a Process Engineer to their team. Our client offers modern CNC equipment, a clean and organized facility, and the opportunity to work on complex precision machined components.

This role is ideal for someone with experience in a precision machining environment who enjoys developing manufacturing processes, working with engineering and production teams, and supporting the launch of new parts into production.

Key responsibilities include:

• Developing detailed manufacturing process plans for new parts using SolidWorks for modeling and drafting and Visual Manufacturing (ERP) for documentation
• Reviewing customer purchase orders, drawings, and specifications to ensure all requirements are incorporated into the manufacturing process plan
• Ensuring manufacturing process plans comply with all drawing, purchase order, and specification requirements
• Reviewing existing tooling and gage inventory for use in the manufacturing process
• Designing and ordering new tooling when necessary
• Working closely with manufacturing teams to troubleshoot and resolve production issues as they arise
• Supporting continuous improvement of manufacturing processes and production efficiency

If you have experience in manufacturing engineering or process engineering within a CNC machining environment and are interested, apply now to learn more!

We are seeking a highly skilled and detail-oriented P&ID Designer or Process Engineer to join our engineering team. The ideal candidate will have hands-on experience in creating and revising Piping and Instrumentation Diagrams (P&IDs) using AutoCAD, Revit, and Plant 3D, with a strong understanding of ISO and industry standards. This role is critical to ensuring accurate documentation of process systems for industrial, manufacturing, or energy projects.

Key Responsibilities:

• Design and revise P&IDs for process systems in compliance with ISO and project-specific standards.
• Collaborate with mechanical, electrical, and process engineers to ensure accurate system representation.
• Use AutoCAD Plant 3D and Revit to model piping layouts, instrumentation, and equipment.
• Maintain and update engineering documentation, including BOMs, datasheets, and control narratives.
• Conduct quality checks and ensure drawings meet regulatory and safety requirements.
• Support project teams during design reviews, construction, and commissioning phases.
• Integrate P&IDs with 3D models and databases for intelligent documentation and asset tracking.

Qualifications:

• Bachelor’s degree in mechanical, Chemical, or Industrial Engineering (or equivalent experience).
• 3+ years of experience in P&ID design or process engineering.
• Proficiency in AutoCAD, Revit, and Plant 3D.
• Strong knowledge of ISO standards and ANSI/ISA instrumentation symbols.
• Familiarity with process control systems and industrial equipment.
• Excellent attention to detail and organizational skills.
• Strong communication and collaboration abilities.

Preferred Skills:

• Experience with SmartPlant P&ID or AVEVA Diagrams.
• Knowledge of BIM workflows and integration.
• Understanding of process safety and HAZOP documentation.
• Ability to automate tasks using scripts or macros in CAD 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.

JOB TITLE: Clinical Review RN (Medicaid Cost Outlier)

Nurse Background: 2+ years of acute care/medical surgical experience required. Interqual/MCG experience a plus.

GENERAL RESPONSIBILITIES: This individual will complete the full spectrum of activities related to Utilization or Quality reviews as assigned. They will utilize their knowledge and expertise of the review program to conduct clinical level review, supporting Medical Review Analysts, and Physician Consultants to ensure an appropriate and accurate process.

DUTIES:

1. Conduct utilization reviews up to and including the appeal level. This includes chart screen, complete electronic worksheets, enter required information and make level one denial decisions when necessary.

2. Conduct quality and clinical study data collection reviews. This includes chart review, complete detailed electronic data worksheets.

3. Act as a resource for the administrative staff in training, problem solving, and clarifying procedures. Will provide technical assistance and conduct/participate in staff huddles.

4. Participate in collaborative training specific to clinical study objectives.

5. Other activities as may be deemed necessary.

QUALIFICATIONS:

1. Licensed as a Registered Professional Nurse in New York State.

2. Knowledge and experience with electronic medical records including utilization, quality, and clinical charting.

3. Ability to oversee, problem solve and work collaboratively with peers, medical, analytical, and administrative support staff.

4. Excellent written and verbal skills.

5. Ability to work independently with little supervision.

6. Ability and desire to be flexible, innovative, and creative.

EDUCATION & EXPERIENCE:

1. Baccalaureate degree in Nursing or graduate of an approved Registered Professional Nurses training program and licensed to practice in the State of New York.

2. A minimum of 2 years experience in an acute care facility preferably in medical surgical and utilization review experience highly preferable.

LOCATION: Jericho, NY (onsite)

***there is a free shuttle from the Jericho LIRR station + parking onsite

SHIFTS: M-F, 40 hours or 4x10s (no weekends)

PAY: $50-55/hr

DURATION: long term open ended contract includes benefits, sick time, 401k, weekly pay

TheSenior Process Engineer is responsible for designing, developing, optimizing and troubleshooting manufacturing processes in a manner that meets safety, quality and operational performance expectations. This position provides leadership and creativity in the formulation development, process development and optimization, scale up and manufacturing. The key function of this role is to identify and solve problems in the manufacturing process transfer and scale up, and deliver effective, safe and efficient manufacturing processes for parenteral drug products. The Senior Process Engineer is hands-on, able to handle multiple tasks with sound planning and communication and providing training and support to peers.

This role will:

• Analyze organic or inorganic pharmaceutical excipients to determine chemical or physical compatibilities with active drug molecules for the development of stable pharmaceutical product
• Evaluate changes in the composition/stability of pharmaceutical products due to changes in variables such as heat, light, or chemical catalysts for quantitative or qualitative analysis
• Propose and prepare formulations with different excipients or solvents to conduct experiments and analytical testing at laboratory scale
• Propose and develop lyophilization product and process or other complex formulation process such as liposome, TFF and viscous product
• Take an active part in scale-up and technology transfer of newly developed products from R&D to manufacturing
• Identify and order materials required to perform development and manufacturing
• Identify tooling and equipment required to perform development and manufacturing
• Create documents for laboratory/manufacturing operations and quality such as master batch records, study protocols, engineering batch record, process characterization reports, standard operating procedures (SOP), etc. Review these documents for their compliance with cGMP and FDA standards
• Due diligence on manufacturing process design and risk analysis to ensure operation safety, efficiency and quality
• Propose testing procedures for analyzing CQA and coordinate with quality control testing to ensure the quality of finished drug product
• Compile and analyze test information to determine process or equipment operating efficiency or to diagnose malfunctions
• Analyze in-process and release testing results to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA) of the pharmaceutical product
• Maintain ownership of assigned laboratory instruments to ensure proper working order and troubleshoot malfunctions when needed
• Study effects of various manufacturing techniques or packaging configuration on the composition or stability of pharmaceutical product
• Develop, improve or customize equipment, formulas, processes or analytical methods to maintain quality of pharmaceutical product
• Write technical papers or reports or prepare standards and specifications for processes, facilities, products, or tests
• Provide leadership in daily operations, and have employees incorporate these compliance practices into their daily routines
• Lead/support validation activities including equipment validation and process validation
• Lead problem solving and investigate quality events related to formulation process or batch records
• Propose and lead process improvement initiatives to improve operating performance and laboratory safety procedures to ensure compliance with the cGMP and FDA standards
• Lead or participate in root cause analysis and quality event investigation such as OOS and deviations
• Supervise, mentor and develop team members or relevant personnel across departments

This role requires:

• A minimum of three (3) years of experience in pharmaceutical research and manufacturing
• Bachelor’s degree or above in Chemical Engineering, Chemistry, Biology or Pharmaceutical Science
• Experience in sterile manufacturing is preferred
• Experience in lyophilization and terminal sterilization techniques are a plus
• Knowledge of parenteral drug product manufacturing
• Proficient with calculation, data analysis, statistics and applied mathematics