The Engineering Services Manager is responsible for management of all CQV and CSV activities on site, along with re-qualification requirements. You will lead a multi-disciplined team of Engineers and Technicians.
- You will have responsibility for commissioning, qualification and validation of all process equipment, facilities and utilities on site.
- Responsibility for computerised system validation requirements on site.
- Responsibility for ongoing equipment re-qualification requirements.
- The Engineering service Manager will be providing validation support to capital projects that are executed on site.
- Ensure that the Capex team is provided with adequate validation support at all times.
- Ensure group completes the review and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports and associated deviations for equipment, facilities & utilities, & computerised systems.
- Ensuring compliance with current industry regulations and guidelines relating to validation.
- Manage department performance against defined KPIs.
- Control and monitor safe working practices of team members and contractors while on site.
- As required. support the Technology Transfer initiatives for incoming new products.
- Implement training programs and maintain up to date training records for all team members personnel.
- Participate fully in cross-functional training initiatives.
- Provide regular reports on the activities of the Engineering Services group to the Head of Engineering.
- Assist with the formation and control of operational budgets.
The next Engineering Services Manager should hold a 3rd level Engineering or Science Degree with at least five years validation management experience (CQV or CSV) within a pharmaceutical setting. You should have a strong knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines
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