MSAT Microbial Process Validation Specialist

Lonza; Oberwallis; On-site; Vertraulich; Full time

Benefits offered by this job

Competitive hourly rate

Job summary

Lonza in Visp, Switzerland is seeking a senior MSAT validation expert to design and implement stage-by-stage microbial process validation strategies, study designs, and reports in full compliance with Lonza VMPs and global regulations. You will partner with R&D during characterization and transfer studies to ensure audit-readiness.

The role leads validation assessments for deviations and change controls, builds CPV plans for long‑term process capability, and reviews Product Quality Reports.

Qualifications

• 5+ years hands-on experience in biopharmaceutical manufacturing, process development, MSAT, or process validation.
• Deep expertise in process validation lifecycle concepts (Stage 1–3), CPV, and Product Quality Reviews (PQRs).
• Strong knowledge of microbial fermentation, primary recovery, downstream purification, and biologics cGMP.

Responsibilities

• Define and implement stage-by-stage microbial process validation strategies, study designs, protocols, and summary reports in full compliance with Lonza VMPs and regulatory expectations.
• Partner with R&D during process characterization and review studies to ensure seamless transfer and audit-readiness.
• Lead and evaluate validation assessments for process deviations and change controls, establishing robust corrective actions.
• Build and maintain data-driven Continued Process Verification (CPV) plans to ensure long-term process capability and control.
• Evaluate and approve annual Product Quality Reviews (PQRs), ensuring strict adherence to global compliance standards.
• Represent MSAT validation as SME during customer quality audits and Health Authority inspections.
• Mentor junior specialists and collaborate with QA Ops, QA Qualification, and cross-functional project teams to support timely validation batch release.

Skills

Biopharma manufacturing

Process validation

MSAT

CPV

PQRs

Team collaboration

Education

Biotechnology/Biology/Biochemical Eng (BSc/MSc/PhD)

Job description

Every day, Lonza’s teams across the world work together to turn scientific breakthroughs into life-changing medicines that reach up to 100 million patients a year. Lonza is a place where people can make a unique impact, grow their careers and belong.

Our MSAT team in Visp delivers high-impact validation strategies for life-saving microbial therapies, ensuring our manufacturing processes consistently achieve world-class quality and regulatory compliance.

This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Competitive hourly rate.

What you will do:

• Define and implement stage-by-stage microbial process validation strategies, study designs, protocols, and summary reports in full compliance with Lonza VMPs and regulatory expectations.
• Partner with R&D during process characterization and review studies to ensure seamless transfer and audit-readiness.
• Lead and evaluate validation assessments for process deviations and change controls, establishing robust corrective actions.
• Build and maintain data-driven Continued Process Verification (CPV) plans to ensure long‑term process capability and control.
• Evaluate and approve annual Product Quality Reviews (PQRs), ensuring strict adherence to global compliance standards.
• Represent MSAT validation as the technical Subject Matter Expert during customer quality audits and Health Authority inspections.
• Mentor junior specialists and collaborate closely with QA Ops, QA Qualification, and cross‑functional project teams to support timely validation batch release.

What we are looking for:

• 5+ years of hands‑on experience in biopharmaceutical manufacturing, process development, MSAT, or process validation.
• In‑depth expertise in process validation lifecycle concepts (Stage 1–3), Continued Process Verification (CPV), and Product Quality Reviews (PQRs).
• Solid technical knowledge of microbial fermentation, primary recovery, downstream purification, and biologics cGMP regulations.
• Proven track record evaluating complex deviations, root‑cause investigations, and risk assessments (e.g., FMEA) in a regulated environment.
• Bachelor’s, Master’s, or PhD in Biotechnology, Biology, Microbiology, Biochemical Engineering, or a related Life Sciences field (equivalent industry experience valued).
• Strong collaborative mindset with experience engaging multi‑disciplinary stakeholders and external clients in a matrix structure.
• Fluency in English (written and verbal); German is a strong advantage.

What you will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast‑moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

Lonza is a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. At Lonza, you will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.

Lonza are the makers of the medicines of tomorrow.