CSV Engineer

Purpose of Role

The CSV Engineer has a key role in ensuring the ongoing validation compliance of computerised equipment and systems in sterile products manufacturing.

Responsibilities

• Integrally involved in the validation of all new computerised equipment, and control systems
• Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for computerised equipment and systems.
• Participates in the change control process advising on CSV issues, as appropriate
• Hands on role in the development and execution of DQ, IQ, OQ and PQ activities.
• Ensures projects are managed in compliance with all required *** and legal requirements (Health & Safety, cGMP, construction, environmental etc).
• Designs, implements and executes validation studies for manufacturing and control equipment. Additional responsibilities for critical systems and facilities as well as validation studies to satisfy regulatory compliance.
• Provide technical assistance on current US FDA and EU validation requirements for lyophilization, aseptic processing and sterilisation.
• Ensure that the validation status of equipment and systems are in compliance with cGMP at all times.
• Maintain validation documentation through the
  • Approval and implementation of changes to relevant systems and assist in generating validation/ revalidation plans
  • Generate/review/approve execution of the validation/revalidation plans
• Review and approval of site change controls
• Ensure compliance to cGMP at all times

Qualifications

• Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
• Post-graduate studies as appropriate to augment primary Degree
• 3-5 years experience working in a Healthcare manufacturing environment – ideally part of which would be in the pharmaceutical sector.
• 2-3 years experience in validation environment
• Project management experience.
• Capable of troubleshooting validation issues associated with projects, process development etc.
• Competent technical knowledge of pharmaceutical plants.
• Knowledge of requirements for of GAMP, ISPE Baseline guides.
• Full understanding of relevant quality and compliance regulations
• Able to execute projects to plan.
• Good knowledge of quality management systems.
• Effective facilitator.
• Good communication skills at organisation, team and individual levels.
• Understands KPI's for the site.

Personal Characteristics

• Natural influencer and works well as part of a multifunctional team.
• Highly motivated and self-resilient.
• Adaptable and flexible as well as a pragmatically minded problem solver.
• Sees projects/tasks through to completion.