MSAT Microbial Process Validation Specialist

ALTEN; Wallis; Vor Ort; CHF 120.000 - 200.000; Vollzeit

Zusammenfassung

ALTEN is seeking a highly skilled MSAT Microbial Process Validation Specialist to join our client's biopharma team. You will provide scientific and regulatory expertise in process validation with a focus on microbial processes and CPV and PQR programs.

You will design and execute validation studies, collaborate with R&D and QA, lead risk assessments, and mentor junior staff while ensuring GMP compliance and regulatory inspections success.

Qualifikationen

• Master's degree in biology or related field with focus on biopharmaceuticals.
• 5–10 years in biopharmaceutical manufacturing and MSAT environments.
• Expertise in CPV, PQR, GMP, and regulatory expectations.
• Experience with deviation management, risk assessments, audits.
• Strong technical writing for validation protocols and reports.

Aufgaben

• Design and implement process validation strategies for microbial/biopharma processes.
• Lead validation assessments and maintain CPV and PQR programs.
• Collaborate with R&D during process characterization and with QA for batch release.
• Review validation documents, change/deviation records for compliance.
• Train and mentor junior team members in validation best practices.

Kenntnisse

MSAT expertise

Regulatory compliance

Process validation

Cross-functional collaboration

Technical writing

Project management

English & German

Ausbildung

Master’s degree in Biology/Life Sciences

PhD preferred

Jobbeschreibung

We are seeking a highly skilled MSAT Microbial Process Validation Specialist to join our client's team in the biopharmaceutical industry. In this role, you will provide scientific and regulatory expertise in process validation, with a focus on microbial processes and biopharmaceutical manufacturing. Your responsibilities will include designing and executing validation studies, ensuring compliance with global regulatory requirements, and maintaining Continued Process Verification (CPV) and Product Quality Review (PQR) programs.

As a key contributor to cross-functional teams, you will lead validation assessments, support lifecycle management of validated processes, and drive continuous improvement in validation strategies. This role is ideal for a detail-oriented, proactive professional with a passion for quality, compliance, and operational excellence.

Key Responsibilities

• Design and implement process validation strategies, including study designs, protocols, and reports, ensuring alignment with regulatory standards (e.g., FDA, EMA).
• Collaborate with R&D teams during process characterization to ensure compliance with regulatory expectations and industry best practices.
• Review and approve process characterization documents, validation assessments, and change/deviation records to maintain compliance.
• Develop and maintain Continued Process Verification (CPV) plans and Product Quality Review (PQR) programs to ensure ongoing process oversight and improvement.
• Participate in cross-functional risk assessments and support customer audits and regulatory inspections to demonstrate compliance and operational excellence.
• Work closely with Quality Assurance (QA) teams to support batch release and validation training programs. Train and mentor junior team members in validation best practices.
• Contribute to the lifecycle management of validated processes, ensuring continuous improvement and adherence to GMP requirements.

Qualifications & Experience

• Master’s degree in Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, or a related Life Sciences field. PhD preferred.
• 5–10 years of experience in biopharmaceutical manufacturing, with a focus on:
  • Process validation
  • MSAT (Manufacturing Science & Technology) environments
  • Continued Process Verification (CPV)
  • Product Quality Reviews (PQR)
  • GMP requirements
  • Regulatory compliance for biologics and microbial processes
• Experience in deviation management, risk assessments, and regulatory inspections/audits.
• Proven ability to train and mentor junior team members in validation best practices.
• Deep knowledge of cGMP regulations and regulatory agency expectations (e.g., FDA, EMA).
• Proficiency in technical writing, including validation protocols, reports, and risk assessments.
• Strong project management and cross-functional collaboration skills.
• Fluent in English and German

The ideal candidate combines:

• Strong scientific expertise in microbial or biopharmaceutical manufacturing.
• Deep knowledge of process validation and regulatory requirements.
• Ability to lead cross-functional initiatives and drive compliance.
• A commitment to continuous improvement in validation strategies.
• Excellent communication, mentoring, and stakeholder management skills.