E-Validation Technician (Long Term Temporary Mission minimum 12 month Contingent)
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Job Summary:
The Validation Technician performs validation and qualification activities, ensuring compliance with cGMP and internal policies and procedures. They are authorized to oversee external vendors performing related work.
Responsibilities:
* Ensure equipment, systems, and processes are qualified, validated, and maintained in compliance throughout their lifecycle.
* Author and review qualification and validation documentation, including risk assessments, protocols, reports, and traceability matrices.
* Execute qualifications for equipment and systems across the site, including QC, production, warehouse, facilities, utilities, and computer systems (excluding global IT systems).
* Conduct validations for processes such as cleaning, bulk processing, packaging, and warehouse sampling.
* Participate in the development and maintenance of local site procedures.
* Contribute to risk assessments and risk management teams.
* Review change controls and NEF documents to assess impacts on qualified systems and validated processes.
* Develop validation approaches based on risk and scientific rationale.
* Coordinate qualification and validation activities, including external vendors and internal departments.
Qualifications:
* BSc in Engineering or a related technical discipline.
* Experience in pharmaceutical qualification and validation; experience in solid dosage manufacturing is advantageous.
Knowledge, Skills, and Abilities:
* Familiarity with international regulatory standards, cGxP, including 21 CFR parts 11, 210, 211, Annex 11, EU-GMP, and GAMP.
* Proficient in English; knowledge of French is advantageous.
* Excellent communication skills and ability to work effectively with cross-functional teams and external vendors.
Additional Details:
* Seniority Level: Entry level
* Employment Type: Temporary
* Job Function: Management and Manufacturing
* Industry: Pharmaceutical Manufacturing
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