QA Validation Manager | Process & Cleaning Validation · CPV · CSV | Biotech GMP · Low Bioburden | (12-month assignment)

Recrutis; Wallis; Vor Ort; CHF 110.000 - 170.000; Vollzeit

Zusammenfassung

Recrutis is supporting a leading biopharmaceutical manufacturing site in Switzerland in search of a QA Validation Manager based in the canton of Valais. The role offers full QA ownership of validation for critical GMP processes and acts as the QA point of contact for validation projects and product transfers.

With 5 to 7 years of pharmaceutical GMP experience, you will oversee manual and automated cleaning validation, review SOPs and reports, and participate in audits and inspections.

Qualifikationen

• Bachelor's degree in science, biotechnology or a related field.
• 5 to 7 years of pharmaceutical industry experience in a GMP-regulated environment.
• Strong knowledge of process validation, cleaning validation, and equipment and system qualification.

Aufgaben

• Ensure critical GMP processes are validated and maintained in compliance with product requirements, process parameters and global regulatory guidelines.
• Oversee validation activities for biotechnological manufacturing processes in a low bioburden environment.
• Support validation of manual and automated cleaning and sanitisation processes, and oversee qualification requirements for related equipment and systems.
• Manage CPV and process validation activities.
• Act as key QA contact for product transfer activities and the associated validation strategy.
• Perform change control and deviation impact assessments, and support non-conformity investigations.
• Review and approve SOPs, protocols, reports, change controls, deviations and other GMP records for QA closure, including Process Validation, Cleaning Validation and CSV documentation.
• Participate in risk assessments, audits and inspections, and support the Data Integrity Program and continuous improvement initiatives.

Kenntnisse

Process validation

Cleaning validation

Quality Assurance

Change controls

Deviation management

Non-conformity investigations

Validation documentation review

Ausbildung

Bachelor's degree in science/ biotechnology or related field

Jobbeschreibung

Recrutis is supporting one of its clients, a leading biopharmaceutical manufacturing site in Switzerland, in the search for a QA Validation Manager, based in the canton of Valais.

Why this role

• Full QA ownership of validation for critical GMP processes: you provide the documented, scientifically sound evidence that processes perform as required across the product lifecycle.
• A visible cross-functional position: you are the QA point of contact for validation projects, product transfers and validation strategy, working directly with MSAT, Manufacturing and clients.
• Technical depth on biotechnological manufacturing in a low bioburden environment, including manual and automated cleaning and sanitisation processes.
• SME role on Process Validation and Cleaning Validation SOPs, with review and approval authority on validation documentation.
• Direct exposure to audits and inspections against both EU GMP and U.S. FDA expectations.

Key information

• Location: canton of Valais, on site.
• Duration: 12 months, from October 2026 to October 2027. Start ASAP / October 2026.
• Seniority: 5 to 7 years of pharmaceutical industry experience in a GMP-regulated environment.
• Education: Bachelor's degree in science, biotechnology or a related field.
• Languages: fluent English required; German is an asset.

Scope

• Ensure critical GMP processes are validated and maintained in compliance with product requirements, process parameters and global regulatory guidelines.
• Oversee validation activities for biotechnological manufacturing processes in a low bioburden environment.
• Support validation of manual and automated cleaning and sanitisation processes, and oversee qualification requirements for related equipment and systems.
• Manage continuous process verification (CPV) and process validation activities.
• Act as key QA contact for product transfer activities and the associated validation strategy.
• Perform change control and deviation impact assessments, and support non-conformity investigations.
• Review and approve SOPs, protocols, reports, change controls, deviations and other GMP records for QA closure, including Process Validation, Cleaning Validation and CSV documentation.
• Participate in risk assessments, audits and inspections, and support the Data Integrity Program and continuous improvement initiatives.

Profile — Required criteria (knockout)

• Bachelor's degree in science, biotechnology or a related field.
• 5 to 7 years of pharmaceutical industry experience in a GMP-regulated environment.
• Strong knowledge of process validation, cleaning validation, and equipment and system qualification.
• Demonstrated experience of change controls, deviation management and non-conformity investigations.
• Proven QA review and approval of validation documentation, not solely authoring or execution.
• Availability to work on site in the canton of Valais for the full duration of the assignment.

Strong assets — Differentiators

• Understanding of cell and gene manufacturing processes and low bioburden environments.
• Experience acting as SME for Process Validation and Cleaning Validation SOPs.
• Exposure to computerised system validation (CSV) and to Data Integrity programmes.
• Experience supporting EU and U.S. FDA audits and inspections.
• German.