Job Description
CSV Engineer
My client a leading Pharmaceutical company now requires a CSV Engineer to join their expanding team.
The CSV Engineer reports to the Engineering Services Manager and will participate in all Computerised System Validation (CSV) activities on site, along with periodic re-qualification requirements and provide CSV support to 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.
This is a permanent role based in Dublin.
Responsibilities of CSV Engineer
- Support the CSV requirements for site production and laboratory systems.
- Support the management of ongoing CSV re-qualification requirements.
- Work cross functionally to develop and deliver the annual CSV 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 CSV activities. For issues that do arise ensure they are closed out in a timely manner.
- Supervise vendors/ contractors on site as required.
- 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.
- Participate in site EHS activities and ensure compliance with legislation and best practice.
- Actively foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business.
- Work with all personnel, contractors and visitors to ensure that all safety policies, procedures and regulations are fully adhered to across the site on an ongoing basis.
- Ensure compliance with legislative requirements as applicable to commissioning activities and contractor management.
Requirements of CSV Engineer
- At least three years validation experience (CSV) within a pharmaceutical setting.
- Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.
- Experience with regulatory audits, in particular representing computer system type issues.
- Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
- Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines would be an advantage.
- Knowledge of working in any of; Active Pharmaceutical Ingredient manufacturing, Drug Product or Secondary Packaging would be an advantage.
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