Senior Validation role supporting site wide critical projects and initiatives. Role is primarily focused on but not limited to computer system validation and automation. Management of a team of approximately 6–8 validation engineers working across all business units. The role will support revalidation activity, data integrity, serialization as well as the manufacturing system technical upgrade.
- Manage direct reports and provide guidance
- Work with the Senior validation team to generate the strategic direction for the department.
- Ensure the correct allocation of validation resources. Support direct reports on site critical projects
- Departmental administration and performance management activities
- Bachelor’s (Level 8) Degree in Computer Science, Computer Engineering or related discipline.
- Thorough understanding and application of GMP and regulatory requirements.
- Advantage to have managed or supervised a team of experienced engineers in a similar industry
- Experience of wide range of validations including, Equipment, Cleaning, Sterilisation, Process Validation and computer system validation.
- At least 5 years’ experience ideally within the clinical, the medical, the laboratory or the pharmaceutical industry
- Understanding of Process Validation, Computer system Validation, SCADA systems, CPV, Sterilization, Packaging systems and related technologies.
- Good knowledge of Validations practices, corporate standards and relevant EU/FDA regulations. Self-sufficiency with a proven track record that demonstrates the ability to work under pressure.
- A strong understanding of current data integrity expectations would be a distinct advantage.
- Comfortable to take on large / complex projects containing multiple modules and multiple Vendors with interlinked systems.
For a confidential discussion and more information on the role, please contact Stephen Kelly on 091-706714.