Kinetic are working with a leading Pharmaceutical Manufacturing company who are hiring a MSAT Microbial Process Validation Specialist for their team in Visp, Switzerland. This is a contract role for 6 months.
Please note that you must meet all the criteria set out below for your application to be considered. Suitable candidates will be contacted within 5 working days. If you are not contacted by us within that time, please consider your application unsuccessful on this occasion.
The main responsibilities will include but not limited to:
- Develop and execute process validation strategies, protocols and reports in line with GMP and regulatory requirements.
- Support process characterisation and validation activities in collaboration with R&D and cross-functional teams.
- Manage validation documentation, including changes, deviations and CAPAs.
- Develop and maintain Continued Process Verification (CPV) programmes and Product Quality Reviews (PQRs).
- Analyse validation data, perform risk assessments and support process improvements.
- Act as the process validation subject matter expert during customer audits and regulatory inspections.
- Collaborate with Quality Assurance to support validation and batch release activities.
To be successful, you will need to meet the following:
- Bachelor’s or Master’s degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology or another relevant Life Sciences discipline. A PhD is preferred.
- Minimum 5 years’ experience within biopharmaceutical manufacturing, with expertise in process validation, process development or MSAT.
- Strong understanding of the process validation lifecycle, Continued Process Verification (CPV), Product Quality Reviews (PQRs), GMP requirements and regulatory expectations for biologics and microbial manufacturing.
- Experience supporting customer audits and regulatory inspections.
- Business fluency in English is essential. German language skills are advantageous.
- Strong analytical, problem-solving and organisational skills.
- Excellent communication and stakeholder management abilities, with experience working in cross-functional and matrix environments.
- Ability to manage multiple priorities while maintaining a high standard of quality and regulatory compliance.
- Must be available to start a 6-month contract.
Must Read: The Problem With AI-Generated CVs: Design, Language and ATS Mistakes.
Hiring? If you need help filling a similar position in your company, please contact us on +44 (0)208 137 0401 or click here.
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