MSAT Microbial Process Validation Lead

ALTEN; Wallis; Vor Ort; CHF 120.000 - 200.000; Vollzeit

Zusammenfassung

ALTEN is seeking a highly skilled MSAT Microbial Process Validation Specialist to join our client's biopharma team. You will provide scientific and regulatory expertise in process validation with a focus on microbial processes and CPV and PQR programs.

You will design and execute validation studies, collaborate with R&D and QA, lead risk assessments, and mentor junior staff while ensuring GMP compliance and regulatory inspections success.

Qualifikationen

• Master's degree in biology or related field with focus on biopharmaceuticals.
• 5–10 years in biopharmaceutical manufacturing and MSAT environments.
• Expertise in CPV, PQR, GMP, and regulatory expectations.
• Experience with deviation management, risk assessments, audits.
• Strong technical writing for validation protocols and reports.

Aufgaben

• Design and implement process validation strategies for microbial/biopharma processes.
• Lead validation assessments and maintain CPV and PQR programs.
• Collaborate with R&D during process characterization and with QA for batch release.
• Review validation documents, change/deviation records for compliance.
• Train and mentor junior team members in validation best practices.

Kenntnisse

MSAT expertise

Regulatory compliance

Process validation

Cross-functional collaboration

Technical writing

Project management

English & German

Ausbildung

Master’s degree in Biology/Life Sciences

PhD preferred

Jobbeschreibung

ALTEN is seeking a highly skilled MSAT Microbial Process Validation Specialist to join our client's biopharma team. You will provide scientific and regulatory expertise in process validation with a focus on microbial processes and CPV and PQR programs.

You will design and execute validation studies, collaborate with R&D and QA, lead risk assessments, and mentor junior staff while ensuring GMP compliance and regulatory inspections success.