Process Engineer

Back Process Engineer QA Analyst (Hardware) Billerica , Massachusetts Temp to Perm Per Hour Aug 19, 2026 $ 50.00 - $60.00

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.

• 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.

• 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., Track Wise, CATSWeb). Skilled at presenting technical content to technical and non-technical audiences.

• 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