MSAT Microbial Process Validation Specialist

Actalent; Oberwallis; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Actalent is seeking a MSAT Microbial Process Validation Specialist in Visp, Switzerland to provide scientific and regulatory expertise in process validation for biopharmaceutical manufacturing. The role involves defining validation strategies, designing and executing validation studies, and authoring protocols and reports in line with VMPs, SOPs, and global regulatory requirements.

Responsibilities include designing validation studies, supporting R&D during characterization, reviewing

Qualifikationen

• Bachelor's or Master's degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology or related Life Sciences; PhD preferred.
• 5-10 years in Biopharmaceutical manufacturing, Process development and validation in MSAT environments.
• Strong understanding of Validation Lifecycle, CPV and PQRs.
• Regulatory expectations for biologics and microbial processes.
• Business fluency in English (written and spoken). German language skills are advantageous.

Aufgaben

• Design and implement validation strategies, preparing validation documents (studies, protocols, reports) per VMPs and regulatory guidelines.
• Support R&D during process characterization ensuring flawless validation execution.
• Review and approve process characterization documents for regulatory alignment.
• Coordinate validation assessments on changes and deviations, approving deviation/change documents.
• Develop and maintain a continued process verification plan for ongoing process oversight.
• Assess and approve Product Quality Reviews ensuring adherence to quality standards.
• Assess validation data for conformance to protocol acceptance criteria and support investigations of deviations.
• Participate in customer audits and HA inspections regarding process validation.

Kenntnisse

Process Validation

CPV

PQRs

Regulatory knowledge

English fluency

Ausbildung

Bachelor's or Master's in Biology/Biotech/Life Sciences

PhD preferred

Jobbeschreibung

For our client based in Visp (Switzerland), we are looking for a MSAT Microbial Process Validation Specialist to provide 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 the Validation Master Plans (VMPs), SOPs, and global regulatory requirements.

Responsibilities:

• Design and implement process validation strategies, preparing validation documents (study designs, protocols, and reports) in strict compliance with 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.
• 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.

Must-haves:

• Bachelor's or Master's degree in, Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, Related Life Sciences discipline. PhD preferred.
• 5-10 years of experience in, Biopharmaceutical manufacturing, Process development and validation and MSAT environments
• Strong understanding of: Process Validation Lifecycle, Continued Process Verification (CPV), Product Quality Reviews (PQRs)
• Regulatory expectations for biologics and microbial processes
• Business fluency in English (written and spoken).
• German language skills are advantageous.

Contract Type:

until 31/03/2027

Start Date:

ASAP

**While we appreciate every application, please note that due to the high volume of responses, we may only be able to contact shortlisted candidates.