Location : Hoofddorp
Duration : 1 year
About the Company
Our client is an innovative biotech company at the forefront of cell therapy, with a state-of-the-art manufacturing facility based in Hoofddorp. The company is dedicated to transforming the lives of patients through advanced therapies, cutting-edge science, and a highly collaborative environment. This is your chance to join a passionate team working on groundbreaking treatments in a fast-growing and dynamic setting.
About the Position
We are seeking a Process Engineer I to join the MSAT (Manufacturing Sciences and Technology) team, specifically supporting Manufacturing Operations and Compliance Support (MOCS). In this role, you’ll help drive continuous improvement and ensure compliance in the production of T-cell therapy products. You’ll work hands-on with deviation investigations, CAPAs, and documentation, collaborating across departments to support the successful manufacturing of life-changing therapies.
Key Responsibilities
-Investigate and resolve deviations using Root Cause Analysis tools
-Develop and implement CAPAs to ensure long-term resolution of issues
-Write and revise SOPs, batch records, and other key operational documents
-Collaborate with technical and operational teams to support process improvements
-Provide hands-on support during audits and other compliance-related activities
-Perform additional duties as assigned by management
Requirements
-BSc in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field
-2–3 years of experience in a GMP pharmaceutical or biotech manufacturing environment
-Background in cell culture, cell therapy, or aseptic processing is highly preferred
-Strong knowledge of manufacturing processes and cGMP compliance
-Experience in investigations, deviation reports, CAPAs, and change controls
-Excellent technical writing and interpersonal communication skills
-Ability to work effectively in cross-functional teams and a fast-paced setting
-Detail-oriented, self-motivated, and adaptable to shifting priorities
If you're passionate about driving improvements in a cutting-edge GMP environment, apply below and be part of something impactful.
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Manufacturing Science & Technology (MSAT) Engineer
Location: Hoofddorp, Noord-Holland
Sector: Pharmaceuticals
About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.