Our client is one of the world's largest Pharmaceutical and Biotechnology companies and has multiple manufacturing sites across Ireland.
With major capital investment happening in their plants, this is an exciting time to join the team.
Participate inall 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.
Ensure compliance with legislative requirements as applicable to commissioning activities and contractor management.
Ensure timely completion of all SOP training and assessment tasks.
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
Excellent technical writing capability
Ability to work well with others across other departments.
Working knowledge of quality systems
Excellent Salary, dependent on experience
Excellent benefits package
Performance Related Bonus
Paid Maternity/Paternity Leave
Educational Assistance Programme
Zero Absence Award
Talent & Development Programme
Occupational Health & Wellness Programme
Karen McHugh is the consultant managing this position.
If you are a CSV Engineer interested in roles based in Dublin , you can contact Karen by e-mail email@example.com or phone +353-1-7978720 for a confidential chat.
JobContax do not send CVs to clients without candidate permission.
With over 50 years of technical recruitment experience, JobContax is the leading recruiter of CSV Engineer in Dublin and Ireland.
Due to the large volume of applications, JobContax may not be able to respond to every individual.