MSAT Microbial Process Validation Specialist

Hard Facts

• Start Date: 01 December 2026
• End Date: 31 July 2027
• Contract Duration: 8 months
• Workload: 100% (41 hours per week)
• Location: Visp, Switzerland
• Work Environment: Biopharmaceutical Manufacturing / MSAT
• Working Hours: Standard daytime working hours
• Travel Requirements: No regular travel required

Tasks and Responsibilities

• Develop and implement process validation strategies in accordance with internal Validation Master Plans (VMPs), SOPs and applicable global regulatory requirements.

• Prepare, review and author validation documentation, including study designs, validation protocols and final reports.

• Support R&D teams during process characterization activities, ensuring the appropriate execution of validation-related tasks.

• Review and assess process characterization documentation to ensure compliance with regulatory standards and internal quality requirements.

• Coordinate validation assessments related to process changes and deviations, including the review and approval of associated change control and deviation documentation.

• Develop, implement and maintain Continued Process Verification (CPV) plans to ensure ongoing process monitoring and control.

• Review and approve Product Quality Reviews (PQRs), ensuring compliance with applicable quality standards.

• Participate in and facilitate cross-functional risk assessments to define the scope and requirements of validation studies and activities.

• Evaluate validation data against predefined protocol acceptance criteria and support deviation investigations, impact assessments and the definition of appropriate corrective actions.

• Act as a process validation subject matter expert during customer audits and health authority inspections.

• Collaborate closely with Quality Assurance Operations (QA Ops) to support batch release activities for processes under validation.

• Support validation training initiatives and coach or mentor junior employees in MSAT validation activities.

• Organize and facilitate cross-functional meetings to ensure effective collaboration with MSAT, QA Validation, Cleaning Validation and QA Qualification teams.

Qualifications

• Bachelor's, Master's or PhD degree in Biotechnology, Biology, Microbiology, Biochemical Engineering or a related Life Sciences discipline.

• At least 5 years of professional experience in biopharmaceutical manufacturing.

• Proven experience in Process Development, Process Validation and/or Manufacturing Science & Technology (MSAT).

• Strong knowledge of Continued Process Verification (CPV), Product Quality Reviews (PQR), GMP requirements and applicable regulatory guidelines.

• Experience with microbial processes and biopharmaceutical manufacturing.

• Practical experience in developing, reviewing and authoring validation protocols, reports and related quality documentation.

• Experience in deviation management, change control, risk assessments and validation-related investigations.

• Fluent English skills, both written and spoken. German is considered an advantage.

Personal Competencies

• Adaptable and comfortable working in dynamic environments with changing priorities and complex challenges.

• Strong analytical and decision-making capabilities, combined with sound business acumen.

• Excellent communication and stakeholder management skills, with the ability to influence cross-functional teams.

• Collaborative mindset and the ability to establish effective working relationships across different functions.

• Strong customer orientation and a results-driven approach.

• High level of integrity, accountability and ownership.

• Excellent written, verbal and presentation skills.

• Ability to manage multiple priorities independently and deliver results within agreed timelines.