Our client is a global biopharmaceutical company based in Waterford, looking for a Validation Engineer to ensure the ongoing validation compliance of equipment, systems and processes at the facility in both solid dosage forms and sterile products manufacturing.
- Integrally involved in the validation of all new equipment, processes and control systems.
- Generates validation documentation (protocols/reports) and provides assistance with the execution of protocols for equipment, process, cleaning, utility, methods, and computerised systems.
- Participates in the change control process advising on validation issues, as appropriate Compliance Related.
- 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 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.
- Generate/review/approve execution of the validation/revalidation plans.
- Review and approval of site change controls.
- Ensure compliance to cGMP at all times.
Qualifications & Experience:
- 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 of experience working in a Healthcare manufacturing environment, ideally part of which would be in the pharmaceutical sector.
- 2-3 years of 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.
- 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.
- Ability to use MS Project and SPC packages an advantage.
- Understands KPI’s for the site.
To apply for this job email your details to firstname.lastname@example.org.