MSAT Validation Expert (Process & Cleaning Validation)

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

We are seeking a highly skilled and motivated MSAT Validation Expert to join our client's team in the biopharmaceutical industry. In this role, you will play a critical part in ensuring compliance, quality, and operational excellence in process and cleaning validation within a large-scale manufacturing environment.

Key Responsibilities

• Design, implement, and optimize validation strategies for process and cleaning activities in a cGMP-regulated biopharmaceutical manufacturing setting.
• Draft, review, and finalize validation protocols and reports in compliance with global regulatory standards (e.g., FDA, Swissmedic, EMA).
• Serve as a technical authority for non-conformity records, change requests, and validation assessments, ensuring robust decision-making and risk mitigation.
• Lead and support PQ studies, ensuring adherence to protocols and regulatory expectations.
• Work closely with cross-functional teams, including Quality Assurance, Manufacturing, and Regulatory Affairs, to align validation activities with business objectives and GMP standards.
• Represent the organization in customer-facing meetings and regulatory inspections, demonstrating compliance and operational excellence.
• Identify opportunities for process optimization, leveraging data-driven insights and industry best practices.

Key Requirements

• Master’s degree or PhD in Biotechnology, Life Sciences, or a related field.
• 5+ years of experience in process validation, with a strong preference for expertise in cleaning validation within a cGMP-regulated biopharmaceutical environment.
• Proven track record in MSAT (Manufacturing Science & Technology) or Quality roles, with experience in upstream/downstream processes (preferably in mammalian cell culture).
• Experience in process development, scale-up, or manufacturing is highly desirable.
• In-depth knowledge of cGMP regulations and regulatory agency expectations (e.g., FDA, Swissmedic, EMA).
• Proficiency in technical writing, including validation protocols, reports, and risk assessments.
• Strong project management skills, with the ability to manage complex, multi-stakeholder projects and meet tight deadlines.
• Familiarity with statistical tools and data analysis for validation studies.
• Fluent in English and German
• Exceptional communication, stakeholder management, and problem-solving abilities.