Validation Specialist

Panda International; Oberwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Panda International is seeking an MSAT Microbial Process Validation Specialist for our client in Visp, Switzerland. The role defines and executes validation strategies across the product lifecycle in a GMP microbial manufacturing environment.

The ideal candidate has a life sciences degree, 5–10 years in biopharma process validation, leads CPV and PQR activities, and collaborates across QA, Manufacturing and R&D; English required, German a plus.

Qualifikationen

• Bachelor's or Master's in Life Sciences required with relevant specialisation.
• 5–10 years of biopharma manufacturing experience.
• Strong background in Process Validation within an MSAT environment.

Aufgaben

• Develop and execute process validation strategies, protocols, and reports in line with GMP and global regulatory requirements.
• Support process characterization activities alongside R&D and Manufacturing teams.
• Lead Continued Process Verification (CPV) and maintain Product Quality Reviews (PQRs).
• Review and approve validation documentation, change controls, and deviations.
• Collaborate on cross-functional risk assessments to determine validation requirements.

Kenntnisse

MSAT validation

Process Validation

GMP

CPV

PQRs

Regulatory

Biologics

Microbial manufacturing

Ausbildung

Bachelor's or Master's in Life Sciences

PhD advantageous

Jobbeschreibung

MSAT Microbial Process Validation Specialist

Visp, Switzerland | Contract

Are you an experienced Process Validation Specialist with a background in biopharmaceutical manufacturing and microbial processes? We're supporting a leading global life sciences organisation in the search for an MSAT Microbial Process Validation Specialist to join their manufacturing site in Visp, Switzerland.

In this role, you'll be responsible for defining and executing process validation strategies across the product lifecycle, ensuring GMP compliance, regulatory readiness, and continuous process verification for microbial manufacturing processes.

What you'll be doing

• Develop and execute process validation strategies, protocols, and reports in line with GMP and global regulatory requirements.
• Support process characterization activities alongside R&D and Manufacturing teams.
• Lead Continued Process Verification (CPV) activities and maintain Product Quality Reviews (PQRs).
• Review and approve validation documentation, change controls, and deviations.
• Participate in cross-functional risk assessments to determine validation requirements.
• Analyse validation data, investigate deviations, and define corrective actions.
• Support customer audits and Health Authority inspections as the MSAT validation expert.
• Work closely with QA Operations to support batch release activities during validation.
• Mentor junior validation professionals and contribute to continuous improvement initiatives.
• Collaborate with QA Validation, Cleaning Validation, Qualification, Manufacturing, and MSAT teams.

What we're looking for

• Bachelor's or Master's degree in Biology, Biotechnology, Microbiology, Biochemical Engineering or a related Life Sciences discipline (PhD is advantageous).
• 5-10 years of experience within biopharmaceutical manufacturing.
• Strong background in Process Validation within an MSAT environment.
• Experience with:
• Process Validation Lifecycle
• Continued Process Verification (CPV)
• Product Quality Reviews (PQRs)
• GMP regulations
• Biologics and microbial manufacturing processes
• Experience managing deviations, change controls, and risk assessments.
• Confident communicating across cross-functional teams and regulatory stakeholders.
• Fluent in English (German is a plus).

Why apply?

• Join one of the world's leading biopharmaceutical manufacturing organisations.
• Work on innovative microbial manufacturing projects.
• Collaborate with international, multidisciplinary teams.
• Be part of a highly regulated environment where your technical expertise has a direct impact on product quality and patient safety.