Principal MSAT Process/Cleaning Validation Expert m/w/d
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3930 Visp, Schweiz |
Temporary Employment
The MSAT Microbial Process Validation Specialist provides scientific and regulatory expertise in process validation for biopharmaceutical manufacturing processes. The role is responsible for defining validation strategies, designing and executing validation studies, and authoring process validation protocols and reports in accordance with Lonza Validation Master Plans (VMPs), SOPs, and global regulatory requirements.
The specialist also develops and maintains Continued Process Verification (CPV) programs and Product Quality Reviews (PQRs) to ensure ongoing process oversight, compliance, and lifecycle management of validated processes.
Zu besetzendes Projekt: Principal MSAT Process/Cleaning Validation Expert m/w/d
Art der Beschäftigung: Payroll
Branche: Biotech
Fähigkeiten: Process Validation
Projektstart: 3 Aug 2026
Projektdauer: 8 months
Einsatzort: 3930 Visp, Schweiz
Key Responsibilities
- Design and implement process validation strategies, preparing validation documents (study designs, protocols, and reports) in strict compliance with Lonza procedures and regulatory guidelines.
- Provide support to R&D teams during the process characterization phase, ensuring the flawless execution of validation activities.
- Review and approve process characterization documents to ensure their alignment with regulatory standards.
- Coordinate validation assessments on changes and deviations, including the approval of deviation and change documents.
- Develop and maintain a detailed continued process verification plan to successfully implement ongoing process oversight.
- Assess and approve Product Quality Reviews, strictly ensuring their adherence to quality standards.
- Participate in or moderate cross-functional Risk Assessments to define the scope of validation/ study activities.
- Assess validation data for conformance to protocol acceptance criteria and support the investigation and evaluation of deviations from the plans as well as the definition of associated corrective measures.
- Process validation specialist in Customer Audits and HA Inspections.
- Ensure the collaboration with QA Ops for batch release of process in validation.
- Supporting validation training programs and train/ mentor junior Lonza employees to better accomplish and perform in their duties as MSAT validation professionals.
- Ensure the organization of meetings for an efficient collaboration with MSAT, QA Validation, Cleaning Validation and QA Qualification (as required)
Qualifications and Experience
- Bachelor's or Master's degree in, Biology, Cell Biology, Biotechnology, Biochemical Engineering, Microbiology, Related Life Sciences discipline. PhD preferred.
- 5-10 years of experience in, Biopharmaceutical manufacturing
- Process development
- Process validation
- MSAT environments
- Strong understanding of:
- Process Validation Lifecycle
- Continued Process Verification (CPV)
- Product Quality Reviews (PQRs)
- GMP requirements
- Regulatory expectations for biologics and microbial processes
- Languages
- Business fluency in English (written and spoken).
- German language skills are advantageous.
- Competencies and Behaviors
- Agility
- Adapts effectively to changing priorities and business needs.
- Treats errors as learning opportunities.
- Navigates ambiguity with confidence and flexibility.
- Business Acumen
- Demonstrates timely and sound decision-making.
- Understands business priorities and operational impacts.
- Escalates issues appropriately and delegates effectively when required.
- Collaboration
- Shares knowledge and information openly across teams.
- Builds strong working relationships across functions.
- Contributes actively to team success and organizational objectives.
- Customer Focus
- Maintains awareness of customer requirements and expectations.
- Communicates customer-related topics effectively across teams.
- Builds strong customer relationships through transparency and technical expertise.
- Driving Results
- Leads multiple complex initiatives simultaneously.
- Delivers commitments with a strong focus on quality, compliance, and timelines.
- Creates accountability and secures commitment on priorities.
- Leadership
- Demonstrates high integrity and accountability.
- Aligns actions and decisions with business objectives.
- Creates an open, inclusive, and learning-oriented environment.
- Influences stakeholders effectively within a matrix organization.
- Communication and Influence
- Excellent verbal, written, and presentation skills.
- Comfortable communicating with senior leadership and external stakeholders.
- Strong networking and relationship-building capabilities.
- Able to engage customers and cross-functional teams effectively.
Preferred Candidate Profile
The ideal candidate combines strong scientific expertise in microbial or biopharmaceutical manufacturing with deep knowledge of process validation and regulatory requirements. They are an influential collaborator who can lead cross-functional initiatives, drive compliance, support inspections and audits, and contribute to the continuous improvement of validation strategies throughout the product lifecycle in Visp, Switzerland.
Referenznummer: 17697
Branche: Biotech
Beginn des Projekts: 3 Aug 2026
Dauer: 8 months
Anstellungsart: Temporary Employment
Kontakt
Luca Furler