MSAT Process & Cleaning Validation Expert

ALTEN; Wallis; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

ALTEN seeks a skilled MSAT Validation Expert to join a biopharmaceutical team in Valais, Switzerland. You will drive process and cleaning validation within a large-scale manufacturing setting, ensuring compliance, quality, and operational excellence.

The role requires designing validation strategies, drafting and reviewing protocols and reports, serving as technical authority, and coordinating with QA, Manufacturing, and Regulatory Affairs to meet GMP expectations.

Qualifikationen

• Master’s degree or PhD in Biotechnology, Life Sciences, or related field.
• 5+ years of experience in process validation with cleaning validation in a cGMP biopharma environment.
• Experience as MSAT or in QA roles with upstream/downstream mammalian cell culture.
• Knowledge of cGMP regulations and regulatory agency expectations (FDA, Swissmedic, EMA).
• Strong technical writing and risk assessment skills.
• Excellent project management and stakeholder coordination.
• Fluent in English and German with strong communication skills.

Aufgaben

• Design, implement, and optimize validation strategies for process and cleaning activities in a cGMP biopharmaceutical setting.
• Draft, review, and finalize validation protocols and reports per global regulatory standards (FDA, Swissmedic, EMA).
• Serve as technical authority for non-conformity records, change requests, and validation assessments.
• Lead and support PQ studies and ensure adherence to protocols.
• Collaborate with QA, Manufacturing, Regulatory Affairs to align validation with GMP standards.
• Represent the organization in customer-facing meetings and regulatory inspections.
• Identify opportunities for process optimization using data-driven insights.

Kenntnisse

MSAT

Process validation

Cleaning validation

Regulatory compliance

Technical writing

Project management

Data analysis

English

German

cGMP knowledge

Ausbildung

Master’s degree

PhD

Biotechnology/Life Sciences

Jobbeschreibung

ALTEN seeks a skilled MSAT Validation Expert to join a biopharmaceutical team in Valais, Switzerland. You will drive process and cleaning validation within a large-scale manufacturing setting, ensuring compliance, quality, and operational excellence.

The role requires designing validation strategies, drafting and reviewing protocols and reports, serving as technical authority, and coordinating with QA, Manufacturing, and Regulatory Affairs to meet GMP expectations.