Engineer, C&Q and CSV (Ref. 2498) - 6 months contract

Your main tasks

• Perform Qualification/Validation Lead role for a defined validation/qualification area.
• Develop and justify the C&Q and CSV approach based on risk and scientific rationale.
• Ensure equipment and systems are qualified, validated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
• Author and when required review validation documents, including requirement specifications, design qualification, qualification/validation plans, protocols, reports, traceability matrix and qualification/validation summary reports.
• Execute qualifications/validations for equipment and/or system or manage people with the role of tester (including vendors) for all equipment and systems across the site, including QC, warehouse, facilities, lab equipment, utilities, and computer system validation.
• Define and execute periodic activities maintaining qualified/Validated states of equipment, analytical instruments, utilities & facilities, and computerized system (Re-qualification).
• Contribute to the development and maintenance of the local site procedures.
• Ensure the Validation strategy on site fit with global validation strategy in collaboration with global team.
• Lead risk assessments and risk management teams.
• Review/assess change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions.
• Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
• Participate in internal and external audits as SME, by answering questions, reviewing qualifications and validations with auditors, and providing documentation.

Your profile

• BS/MS in Engineering/Technical discipline or equivalent experience
• Several Years’ experience with Pharmaceutical Validation
• Strong Knowledge with current international regulatory regulations, cGxP requirements and best practices, including 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP.
• Good ALCOA & Data Integrity knowledge
• Knowledge of pharmaceutical facilities (including HVAC and utilities), manufacturing and laboratory equipment/systems and computerized system validation (CSV)
• Communicates pro-actively and collaboratively.
• Proactively identifies problems and recommends solutions Team player: ability to interact effectively with team and customers.
• Good level of English, French is ideal but not mandatory

Sebastian Pal is looking forward to receiving your application documents via our job portal (CV, diploma, reference letters; no motivational letter necessary).

Full discretion is guaranteed and we will gladly answer any additional questions.