CQV Engineer
il y a 3 semaines
PharmEng Technology is a global pharmaceutical compliance consulting firm with a strong presence in the industry. We are seeking a highly skilled CQV Engineer to join our team in France.
Job OverviewThe successful candidate will be responsible for providing direct services to site Technical Services management, aiding to increase the throughput of commissioning and qualification activities through the department and across the site.
Key Responsibilities- Perform activities related to commissioning, qualification, requalification, and validation independently.
- Commission, qualify, and requalify new or existing manufacturing and laboratory equipment, facilities, services, and systems following regulatory guidelines such as GMPs or FDA.
- Qualify computerized and automation systems.
- Write qualification documents such as VP, IQ, OQ, PQ, and PPQ protocols and reports, risk assessments, and development protocols.
- Provide support for the development of user requirements and functional specifications.
- Actively participate in all phases of validation projects in accordance with client needs.
- Bachelor's degree in a technical field (engineering, biology, chemistry, pharmacy).
- At least 3 years of experience in QA Oversight for C&Q activities, in Biopharma or Pharma industry.
- Generation and overview qualification documents like URS, System Risk Assessment, DQ, IQ, OQ, PQ, SOPs.
- Hands-on commissioning, qualification, and validation experience in facilities, utilities, major qualification equipment, process and cleaning validation, equipment qualification, and computer software validation.
- Full-time position.
- Competitive salary.
- Opportunities working for a global company.
- Thirty (30) days holiday.
- Continuous professional improvement.
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