Manufacturing Process Engineer

SIRE LIFE SCIENCES; Hoofddorp; On-site; EUR 50,000 - 70,000; Full time

Job summary

SIRE LIFE SCIENCES is seeking a Process Engineer based in Hoofddorp, Netherlands. This role focuses on supporting commercial cell therapy manufacturing through technical investigations, compliance activities, and continuous improvement initiatives. Candidates should hold a Bachelor's degree in Biochemical Engineering or related fields and possess hands-on experience in cell therapy and aseptic processing within a GMP-compliant environment. The position demands excellent collaboration skills and the ability to troubleshoot manufacturing issues effectively.

Qualifications

• 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.
• Proven ability to lead root-cause investigations and troubleshoot manufacturing issues.

Responsibilities

• Conduct root-cause investigations and resolve manufacturing deviations.
• Develop, revise, and maintain SOPs and GMP-related operational documentation.
• Collaborate with cross-functional teams to support product release activities.

Skills

cGMP compliance

root-cause analysis

collaboration

process optimization

Education

Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology or related field

Job description

The Company

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.