Description:
This role provides technical leadership and hands on support for sterile manufacturing operations, including Blow Fill Seal, prefilled syringe filling, sterile bag filling, formulation, sterile filtration, aseptic processing, component preparation, visual inspection, and related process interfaces. This role ensures sterile processes are scientifically sound, validated, robust, compliant, and continuously improved, serving as a technical bridge between Manufacturing, QA, QC Microbiology, Engineering, Validation, Regulatory Affairs, Supply Chain, and Product Development/Technology Transfer.
Essential Functions:
- Provide technical support for sterile operations (BFS, prefilled syringes, bag filling, formulation, filtration, aseptic transfers, filling setup, container closure, visual inspection)
- Lead or support validation lifecycle activities (PPQ, CPV, monitoring, trending) and manage tech transfer, scale up, site transfer, new product introduction, and lifecycle management
- Serve as MS&T SME for deviations, non conformances, OOTs, failures, yield losses, contamination events; lead investigations, impact assessments, CAPAs, and batch disposition support
- Establish and improve control strategies (CPPs, CQAs, IPCs, parameters, criteria) and support contamination control, APS, EM trending, cleanroom controls, and sterile assurance investigations
- Partner with Engineering, Manufacturing, Validation, QA, and Automation on equipment qualification, process improvements, facility upgrades, and manufacturing readiness; lead or support change control assessments
- Author/review technical documents (protocols, reports, SOPs, risk assessments, CPV, investigations), support audits and regulatory inspections, and provide technical coaching to junior staff and project teams
Education:
Bachelors Degree (BA/BS) Pharmaceutical Sciences, Pharmacy, Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Microbiology, Biology, Chemistry, Biotechnology, Life Sciences, or a related scientific or technical field. - Required
Experience:
- 5 years or more in Experience in pharmaceutical manufacturing, MS&T, technical services, process engineering, validation, process development, sterile operations, or technical operations.
- 3 years or more in Experience in sterile manufacturing and Blow-Fill-Seal, prefilled syringes, sterile bag filling, sterile filtration, vial filling, cartridge filling, formulation, or aseptic filling
- 5 years or more in Experience with PPQ, CPV, process characterization, technology transfer, or continued process monitoring.
3 years or more in Experience supporting FDA, EMA, customer, or internal audits, statistical process control, Minitab, JMP, or similar data analysis tools.
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Specialized Knowledge:
Strong technical judgment in sterile manufacturing and aseptic processing. Ability to troubleshoot complex manufacturing, process, equipment, and contamination-control issues. Strong technical writing, data analysis, and investigation skills. Ability to lead cross-functional teams and influence without direct authority. Strong communication skills with Manufacturing, QA, QC, Engineering, Validation, Regulatory, and Supply Chain. Ability to manage multiple priorities in a fast-paced GMP manufacturing environment. High attention to documentation quality, compliance, audit readiness, and patient safety. Practical, floor-oriented problem-solving mindset with the ability to translate technical knowledge into executable manufacturing solutions.
Additional Requirement: This position requires successful completion of an OSHA-compliant Respirator Fit Test.
The base salary for this position ranges from $145,000 to $160,000 per year. Amneal ranges reflect the Company’s good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location and other relevant skills. At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that helps you enjoy your career alongside life’s many other commitments and opportunities.
Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [email protected] . Requests will be handled confidentially and in accordance with applicable laws.
