Description

Providing Flexible Resourcing Solutions

Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.

An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.

MSAT Microbial Process Validation Specialist – 7180

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is recruiting for a MSAT Microbial Process Validation Specialist to be based in Visp, Switzerland for a 8 months contract with extension .

The MSAT Microbial Process Validation Specialist provides scientific and regulatory expertise in process validation for biopharmaceutical manufacturing processes. The role is responsible for defining validation strategies, designing and executing validation studies, and authoring process validation protocols and reports in accordance with Lonza Validation Master Plans (VMPs), SOPs, and global regulatory requirements.

The specialist also develops and maintains Continued Process Verification (CPV) programs and Product Quality Reviews (PQRs) to ensure ongoing process oversight, compliance, and lifecycle management of validated processes.

Main Responsibilities:

• Design and implement process validation strategies, preparing validation documents (study designs, protocols, and reports) in strict compliance with Lonza procedures and regulatory guidelines.
• Provide support to R&D teams during the process characterization phase, ensuring the flawless execution of validation activities.
• Review and approve process characterization documents to ensure their alignment with regulatory standards.
• Coordinate validation assessments on changes and deviations, including the approval of deviation and change documents.
• Develop and maintain a detailed continued process verification plan to successfully implement ongoing process oversight.
• Assess and approve Product Quality Reviews, strictly ensuring their adherence to quality standards.
• Participate in or moderate cross-functional Risk Assessments to define the scope of validation/ study activities.
• Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures.
• Process validation specialist in Customer Audits and HA Inspections.
• Ensure the collaboration with QA Ops for batch release of process in validation.
• Supporting validation training programs and train/ mentor junior Lonza employees to better accomplish and perform in their duties as MSAT validation professionals.
• Ensure the organization of meetings for an efficient collaboration with MSAT, QA Validation, Cleaning Validation and QA Qualification (as required)

Qualifications and Experience:

·      Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required

• Bachelor’s, Master’s, or PhD in Biotechnology, Biology, Microbiology, Biochemical Engineering, or a related 
• Life Sciences field.
• 5+ years of experience in biopharmaceutical manufacturing.
• Experience in Process Development, Process Validation, and MSAT.
• Strong knowledge of CPV, PQRs, GMP, and regulatory requirements for biologics and microbial processes.
• Fluent in English; German is an advantage.

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.