Validation Engineer, Operations

Our client is a global biopharmaceutical company located near Neuchatel, Switzerland.

Focused on research, development, and delivery of innovative medicines across several therapeutic areas, including oncology, hematology, immunology, and cardiovascular disease.

The Role

To perform validation and qualification activities in compliance with cGMP as well as internal policies and procedures. Will be authorized to direct external vendors performing work in this field.

Responsibilities:

1. May be assigned Qualification/Validation Lead role for a defined validation/qualification area.
2. Develop and justify the validation approach based on risk and scientific rationale.
3. Ensure equipment and systems are qualified, validated, and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
4. Author and review validated documents, including requirement specifications, qualification/validation plans, protocols, reports, traceability matrix, and summary reports.
5. Execute qualifications/validations or manage personnel (including vendors) performing testing for equipment and systems across the site, such as QC, warehouse, facilities, lab equipment, utilities, and computer system validation, excluding global IT systems.
6. Define and execute periodic activities to maintain qualified/validated states of equipment, analytical instruments, utilities, facilities, and computerized systems.
7. Contribute to the development and maintenance of local site procedures.
8. Ensure the validation strategy aligns with the global validation strategy in collaboration with the global team.
9. Lead risk assessments and risk management teams.
10. Review and assess change controls and maintenance interventions, evaluating their impact on qualified systems and validated processes, and document required actions.
11. Coordinate qualification and validation activities, including external vendors and internal departments.
12. Supervise internal and external resources dedicated to projects.
13. Lead the onboarding process for new validation activities.
14. Participate in internal and external audits as SME, answering questions, reviewing qualifications and validations with auditors, and providing documentation.
15. Establish and maintain effective relationships with internal teams, customers, and suppliers.
16. Contribute to continuous improvement by proactively identifying problems and proposing solutions.
17. Work autonomously, completing tasks independently while seeking guidance on complex or nonroutine decisions.
18. Participate in projects and initiatives as directed by leadership.

You

Our client seeks candidates with the following qualifications and competencies:

1. BS/MS in Engineering/Technical discipline or equivalent experience.
2. 3-5 years of experience in pharmaceutical validation.
3. Strong knowledge of international regulatory regulations, cGxP requirements, and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines, and GAMP.
4. Good knowledge of ALCOA & Data Integrity principles.
5. Knowledge of pharmaceutical facilities (including HVAC and utilities), manufacturing and laboratory equipment/systems, and computerized system validation (CSV).
6. Proactive communication and collaboration skills.
7. Ability to identify problems proactively and recommend solutions.
8. Team player with effective interaction skills.