MSAT Microbial Process Validation Specialist (7034)

Contract

Posted 1 day ago

Recruiter: Usha Rao

MSAT Microbial Process Validation Specialist – 7034 URA

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a MSAT Microbial process validation specialist for 8 monthscontract role based in the Valais area, Switzerland.

The ideal candidate combines strong scientific expertise in microbial or biopharmaceutical manufacturing with deep knowledge of process validation and regulatory requirements. They are an influential collaborator who can lead cross-functional initiatives, drive compliance, support inspections and audits, and contribute to the continuous improvement of validation strategies throughout the product lifecycle

The MSAT Microbial Process Validation Specialist provides 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 companies Validation Master Plans (VMPs), SOPs, and global regulatory requirements.

The specialist also develops and maintains Continued Process Verification (CPV) programs and Product Quality Reviews (PQRs) to ensure ongoing process oversight, compliance, and lifecycle management of validated processes.

Main Responsibilities:

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

·Participate in or moderate cross-functional Risk Assessments to define the scope of validation/ study activities.

·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.

·Ensure the collaboration with QA Ops for batch release of process in validation.

·Supporting validation training programs and train/ mentor junior employees to better accomplish and perform in their duties as MSAT validation professionals.

·Ensure the organization of meetings for an efficient collaboration with MSAT, QA Validation, Cleaning Validation and QA Qualification (as required)

Qualifications and Experience:

·Relevant working/residency permit or Swiss/EU-Citizenship required

·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, Process validation in 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) and German language skills are advantageous.

·Excellent verbal, written, and presentation skills.

·Comfortable communicating with senior leadership and external stakeholders.

·Strong networking and relationship-building capabilities.

·Able to engage customers and cross-functional teams effectively.