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.
- 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.
- 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.
Environmental Health and Safety:
- 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 GC 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.
- Preparation and delivery of training material as required.
- Ensure timely completion of all SOP training and assessment tasks.
- Ensure that all training and assessment is accurately and promptly recorded for themselves and other relevant personnel in accordance with TILGC procedures.
- Maintain and improve their professional knowledge base. Keep up to date with all current trends and relevant legislation.
- Participate fully in any cross functional training initiatives.
- Drive and promote the corporate values of Takeda-ism within the workplace.
- Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.
- 3rd level Engineering or Science Degree, or equivalent
- 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 ability to work in a highly regulated industry and strive for continuous improvement.
- Excellent interpersonal and communication skills.
- Strong Quality orientation
- Well organised and adaptable to change.
- Excellent technical writing capability
- Ability to work well with others across other departments.
- Working knowledge of quality systems
- Ability to work on own initiative.
- Willingness to contribute beyond role specific duties and participate in site improvement initiatives.
Grange Castle, Ireland