Position Summary:
Client is seeking an experienced and driven
Process Engineer to support key functions for radiopharmaceutical manufacturing which includes product support, process support, process engineering, equipment/utility engineering, maintenance programs, and technical troubleshooting in support of automated manufacturing lines. The individual brings hands-on experience in cGMP manufacturing support, with a strong understanding of sterile drug production, radiopharmaceutical workflows, and medical device quality systems.
Key Responsibilities:
- Provide day-to-day technical support to manufacturing operations, ensuring reliable production.
- Lead investigations for moderate- to high-complexity deviations, perform root cause analyses, and implement CAPAs in collaboration with QA and operations teams.
- Author and revise controlled documents, including manufacturing documentation, technical reports, protocols (e.g., process validation, equipment qualification), and risk assessments.
- Support process monitoring, trending, and data analysis activities to drive continuous improvement and maintain a state of control.
- Participate in cross-functional teams for process changes, equipment upgrades, and lifecycle projects, ensuring alignment with regulatory and quality requirements.
- Act as a technical contributor in change control execution, including impact assessments, protocol generation, and implementation planning.
- Support and/or lead multiple technical transfers, scale-ups, and process validation activities.
- Collaborate with stakeholders in Manufacturing, QA, QC, Engineering, and Supply Chain to ensure timely and compliant execution of manufacturing campaigns.
- Ensure compliance with applicable regulations, including 21 CFR Parts 210, 211, 820, EU GMP Annex 1, and radiation safety requirements.
- Support readiness activities for internal and regulatory audits, including documentation review and SME participation.
Qualifications:
- Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Nuclear Engineering, Chemistry, or a related technical field (advanced degree preferred).
- 6+ years of experience in medical device manufacturing, with a strong focus on sterile injectable or radiopharmaceutical production. is a plus.
- Solid understanding of cGMPs, aseptic processing, cleanroom operations, and medical device/combination product regulations (21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485).
- Demonstrated ability to investigate deviations, problem solve, and execute changes within a quality system framework. Advanced technical writing skills required.
- Hands-on experience with equipment commonly used in sterile fill/finish operations.
- Demonstrated ability to lead process validation, equipment qualification, and risk management effor
- Self-starter with strong interpersonal and communication skills; able to work independently and in cross-functional teams.
- Proficiency in Excel, data analysis tools, and electronic document/change control systems (e.g., TrackWise, CATSWeb). Skilled at presenting technical content to technical and non-technical audiences.
Preferred Experience:
- Expereince with lean manufacturing principles and driving process improvements in any scale.
- Experience in lifecycle management of commercially approved pharmaceutical products and devices.
- Experience in managing large cross-functional projects in a matrix environment.
Pay range $40-$50/hr
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