MSAT Microbial Process Validation Lead (8-Month Contract)

CTC Resourcing Solutions; Oberwallis; Vor Ort; CHF 101.475 - 166.050; Teilzeit

Zusammenfassung

CTC Resourcing Solutions is seeking an MSAT Microbial Process Validation Specialist for an 8-month contract in the Valais region of Switzerland. The role focuses on defining validation strategies and leading validation studies for biopharmaceutical manufacturing processes.

The ideal candidate brings 5–10 years of experience in biopharmaceutical manufacturing, expertise in CPV, PQRs, and regulatory expectations for biologics and microbial processes; English is essential, German a plus.

Qualifikationen

• Bachelor’s or Master’s in Biology, Biotechnology, or related Life Sciences; PhD preferred.
• 5–10 years of biopharmaceutical manufacturing experience.
• Experience in process development and MSAT process validation.
• Strong knowledge of CPV, PV lifecycle, and PQRs.
• English required; German language skills advantageous.

Aufgaben

• Design and implement process validation strategies, preparing validation documents in accordance with VMPs and regulatory guidelines.
• Provide support to R&D during process characterization and ensure flawless execution of validation activities.
• Review and approve process characterization documents for regulatory alignment.
• Coordinate validation assessments on changes and deviations, including approval of deviation and change documents.
• Develop and maintain a detailed continued process verification plan for ongoing oversight.

Kenntnisse

Process validation

CPV (Continued Process Verification)

Regulatory requirements knowledge

Biopharmaceutical manufacturing

R&D collaboration

Ausbildung

Bachelor’s or Master’s degree in Biology/Biotechnology/Life Sciences

PhD preferred

Tools

Regulatory guidelines familiarity

Jobbeschreibung

CTC Resourcing Solutions is seeking an MSAT Microbial Process Validation Specialist for an 8-month contract in the Valais region of Switzerland. The role focuses on defining validation strategies and leading validation studies for biopharmaceutical manufacturing processes.

The ideal candidate brings 5–10 years of experience in biopharmaceutical manufacturing, expertise in CPV, PQRs, and regulatory expectations for biologics and microbial processes; English is essential, German a plus.