Qualification and Validation Engineer
We are seeking a dedicated Qualification and Validation Engineer to support and execute qualification and validation activities across a dynamic pharmaceutical manufacturing environment. This role ensures that all systems, equipment, and processes meet regulatory and internal compliance standards throughout their lifecycle.
The successful candidate will also coordinate with external service providers and internal stakeholders to ensure timely and compliant execution of validation tasks.
Key Responsibilities
- Lead and execute qualification and validation activities for equipment, systems, utilities, facilities, and processes across the site
- Prepare and review documentation such as risk assessments, validation plans, protocols, reports, traceability matrices, and summary reports.
- Ensure compliance with internal procedures and current regulatory requirements (e.g., EU GMP, 21 CFR Part 11, Annex 11, GAMP).
- Support validation efforts for manufacturing, cleaning, packaging, and warehouse processes.
- Participate in risk assessments and contribute to the development of site-specific validation strategies.
- Evaluate change controls and assess their impact on validated systems and processes.
- Coordinate validation activities with cross-functional teams and external vendors.
- Contribute to the continuous improvement and maintenance of local validation procedures.
Qualifications & Experience
- Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
- Minimum 2 years of experience in equipment and process validation within the pharmaceutical industry; experience in solid dosage manufacturing is a plus.
- Strong understanding of cGMP, GxP, and international regulatory standards.
- Familiarity with computerized system validation and data integrity principles.
Skills & Competencies
- Excellent communication skills in English; French is an asset.
- Strong organizational and documentation skills.
- Ability to work collaboratively across departments and with external partners.
- Proactive, detail-oriented, and solution-focused mindset.
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