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Engineering Services Manager

Job description

 

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.

 

Job Responsibilities;

  • 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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