Job Description:
Validation Engineer
Key Accountabilities
§ Hands on role in the development and execution of DQ, IQ, OQ and PQ activities. <
§ Designs, implements and executes validation studies< for manufacturing and control equipment. Additional responsibilities toward 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 solid dose manufacture and 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
- Review/approve execution of the validation/revalidation plans<
Skills & Knowledge
§ 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.
§ Knowledge of steam and dry heat validation publications such as< AAMI/ANSI, PDA and ISO guidelines.
§ 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.
§ Ability to use MS Project and SPC packages an advantage
Understands KPIs for the site<
Qualifications
§ Degree in Science (Chemistry, Micro. or Pharmacy preferred) or Engineering (Chemical/Mech/Elec)
§ Post-graduate studies as appropriate to augment primary degree
Experience
· 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.
Please forward c.v in the strictest of confidence to Martin OLeary moleary@brunel.ie or call on 051-309652