My client a leading Pharmaceutical company now requires a CQV Engineer to join their expanding team.
The CQV Engineer will be involved in all Commissioning, Qualification and Validation (CQV) activities on site, along with equipment re-qualification requirements. Provide CQV support to locally managed capital projects that are executed on site.
The role requires a thorough understanding and experience of the validation requirements associated with a pharmaceutical manufacturing facility.
Responsibilities of CQV Engineer
- Support the commissioning, qualification and validation of all process equipment, facilities and utilities on site.
- Support the management of ongoing equipment re-qualification requirements.
- Work cross functionally to develop and deliver annual equipment re-qualification requirements.
- Provide CAPEX team with adequate validation support at all times.
- Review vendor documents to support commissioning and qualification requirements.
- Completes the development, review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
- Ensures validation non-conformances or deviations are minimised during execution of CQV activities. For issues that do arise ensure they are closed out in a timely manner.
- Supervise vendors/ contractors on site during commissioning activities.
- Ensuring compliance with current industry regulations and guidelines relating to validation.
- Support department performance against defined KPIs.
- As required. support the Technology Transfer initiatives for incoming new products.
- Participate in the control of Safety and Environmental programmes.
- Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
- Encourage actively the culture of teamwork and integration within the Engineering Services Department, and with all other Departments.
- Participate fully in cross-functional training initiatives.
- At least three years validation experience (CQV or CSV) within a pharmaceutical setting.
- Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.
- Experience with regulatory audits, in particular representing equipment qualification type issues.
- Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
- Experience in writing Validation Master Plans.
- Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines
- Knowledge of working in any of the following would be an advantage; Active Pharmaceutical Ingredient manufacturing, Drug Product or Secondary Packaging.
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The RFT Group, BioPharmaceutical Division specialize exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.
For more information please contact John at The RFT Group / www.rftgroup.ie / 01 2302400 or click apply below