Manufacturing Process Engineer
First seen by Alion on May 12, 2026. SIRE Life Sciences scores B on the Alion truth index.
Our client is a global leader in advanced cell therapy, specializing in developing and delivering cutting-edge treatments for patients with serious illnesses. The organization operates state-of-the-art manufacturing facilities and follows the highest GMP standards to ensure quality and safety.
About the Role:
The Process Engineer role focuses on supporting commercial cell therapy manufacturing through technical investigations, compliance activities, and continuous improvement initiatives. The position involves collaborating with cross-functional teams to manage deviations, perform root-cause analysis, implement CAPAs, and maintain GMP-compliant documentation. Candidates should have a strong background in biochemical or chemical engineering, along with hands-on experience in cell therapy, aseptic processing, and cGMP-regulated environments.
Responsibilities:
- Conduct root-cause investigations and resolve manufacturing deviations using structured problem-solving and RCA tools.
- Develop, revise, and maintain SOPs, batch records, CAPAs, deviation reports, and other GMP-related operational documentation.
- Collaborate with cross-functional technical and operational teams to support product release activities and manufacturing compliance.
- Drive continuous improvement initiatives and support process optimization projects within commercial cell therapy manufacturing operations.
- Ensure compliance with cGMP standards while supporting aseptic processing, troubleshooting manufacturing issues, and implementing corrective actions.
Requirements:
- Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field; an Engineering degree is highly preferred.
- Hands-on experience in cell culture, cell therapy manufacturing, and/or aseptic processing within a regulated biopharmaceutical environment.
- Strong knowledge and practical experience with cGMP compliance, including deviation investigations, CAPA management, change controls, and technical documentation.
- Proven ability to lead root-cause investigations, troubleshoot manufacturing issues, and apply scientific and engineering principles to process improvements.
- Excellent communication and collaboration skills with the ability to work effectively in cross-functional teams within a fast-paced and evolving manufacturing environment.
Other Information:
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