Process Engineer

SIRE LIFE SCIENCES; Hoofddorp; On-site; EUR 60,000 - 80,000; Full time

Job summary

A leading organization in cellular medicine seeks a Process Improvement Specialist in Hoofddorp. The successful candidate will collaborate with teams to create standard operating procedures, lead investigations into deviations, and support continuous improvements in manufacturing processes. This role requires a Bachelor’s degree in a relevant field and experience in cell culture or aseptic processing, with strong knowledge of cGMP compliance. Candidates should possess excellent communication skills and the ability to work independently.

Qualifications

• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field.
• Relevant experience in cell culture, cell therapy, or aseptic processing.
• Strong knowledge of cGMP compliance, with experience in investigating deviations.

Responsibilities

• Collaborate with teams to create and update operational documents.
• Lead investigations into deviations and develop corrective actions.
• Support continuous improvement initiatives to optimize manufacturing processes.

Skills

Cell culture

Root cause analysis

cGMP compliance

Communication skills

Troubleshooting skills

Education

Bachelor’s degree in Biochemical Engineering

Job description

Company

Our client is a leading organization in the field of cellular medicine, committed to advancing innovative therapies and pushing the boundaries of healthcare through cutting‑edge manufacturing practices and continuous improvement.

Job Description

We are seeking a dedicated Process Improvement Specialist to join the Manufacturing Operations and - Compliance Support team within the Manufacturing Science and Technology (MSAT) department. The successful candidate will support product release, investigate root causes of deviations, and contribute to ongoing process enhancements at a facility manufacturing T‑cell therapy products.

Responsibilities

• Collaborate with technical and operational teams to create, review, and update standard operating procedures (SOPs), batch records, and other operational documents.
• Lead investigations into deviations, applying root cause analysis tools to identify underlying issues.
• Develop and implement corrective and preventive actions (CAPAs) to resolve root causes and ensure long‑term effectiveness.
• Support continuous improvement initiatives to optimize manufacturing processes.
• Assist with impact assessments related to product release and participate in validation activities.
• Perform additional tasks as assigned by management, supporting overall manufacturing excellence.

Requirements

• Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field; engineering degrees are advantageous.
• Relevant experience in cell culture, cell therapy, or aseptic processing.
• Strong knowledge of cGMP compliance, with experience in investigating deviations, writing reports, and managing change controls.
• Excellent communication skills and ability to collaborate effectively across cross‑functional teams.
• Practical understanding of scientific and engineering principles.
• Ability to adapt quickly in a fast‑paced, growing environment and work independently.
• Self‑motivated, detail‑oriented, with strong troubleshooting skills.

Other Information

If you are interested and want to apply, please submit your application via the apply button below and contact me.