Process Engineer - Investigations - Cell Therapy, Hoofddorp

In this role, you focus on investigations after deviations to continuously improve the quality at this modern biotech firm. Apply today if you are interested in root‑cause analysis, continuous improvement, and implementing changes.

Job description You are part of a leading biotech firm and in the MSAT team as a process engineer. Whenever something goes wrong, you and your team are consulted to dive into the issue and provide a solution. This typically is an investigation or root‑cause analysis after a deviation, followed by CAPA‑implementation and management. With the continuous improvement mindset, you also pro‑actively review SOPs and GMP‑records and rewrite these if needed to decrease the chances of mistakes or deviations. Given the nature of the work, you collaborate with production, QC, and QA extensively. We are looking for someone with a few years of relevant experience in a GMP‑environment, leading investigations and (re)writing GMP‑documents. The work in this department is fast‑paced and non‑routine in a highly‑regulated environment.

Responsibilities

Investigations after deviations

Continuous improvement

Root‑cause analysis to resolve deviations

Implementing and managing CAPAs

Writing reports

Collaboration with other departments

Profile

Bachelor’s degree in a relevant field

Strong understanding of pharmaceutical processes and GMP‑guidelines

Experience leading investigations and implementing CAPAs

Strong communication skills to collaborate with several departments

Experience with GVAULT, Oracle EBS, and LIMS are a big plus

Practical information and Benefits

Fulltime position - 40 hours per week.

Up to two days remote, at least three on site

Salary:€58230,- annually

Travel costs reimbursed

28 holiday days per year

Location: Hoofddorp

Vacaturenummer: 27264

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