Purpose
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 Company 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.
* 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.