Our client, a medical device company in Limerick are currently looking to recruit a Senior Validation Engineer for their site on a contract basis.
- The Validation Engineer is a member of the QA Validation team, playing a key role in the planning and execution of validation activities related to project.
- Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project, is critical to the start-up, license approval and the on-going sustaining operations of facilities.
- All validation activities are conducted in compliance with US and EU legislation; as well as company Standards and Guidelines to allow a facility to be qualified in accordance with the project requirements of quality, safety, schedule and budget. Primary Tasks and
- Conduct validation activities in compliance with US and EU regulations, GBSC procedures and EHS requirements.
- Participate in the design of systems and equipment to ensure that they comply with GMP requirements.
- Develop validation documentation as required (e.g. specifications, plans, protocols, procedures).
- Review and approve documents prepared by the validation team, other departments and contractor organisations (e.g. commissioning test plans, impact assessments, change controls).
- Execute qualification protocols as required.
- Compile relevant documentation from contractors, suppliers, and other departments for inclusion in reports.
- Prepare reports of executed protocols for review by QA.
- Initiate and implement change control activities in accordance with site procedures.
- Track and resolve exceptions during qualification activities.
- Prioritize qualification activities in line with the project schedule.
- Co-ordinate qualification activities with engineering, construction and commissioning activities.
- Co-ordinate qualification activities with contractors and vendors as required.
- Co-ordinate qualification document review and approval.
- Collate and organize qualification files for turnover to QADC.
- A degree qualification in science or engineering.
The person will have a proven track record in the qualification of any of the following systems:
- Qualification of Cell Culture Technologies.
- Qualification of Purification – Chromatography and Ultrafiltration Technologies.
- Qualification of Production Support Equipment.
- Qualification of Clean Utilities.
- Qualification of HVAC (ISO classes 5 to 8).
- Qualification of Control Systems – Emerson DeltaV, Honeywell Building Management Systems and Siemens PLCs.
- Qualification experience in a project environment within the pharmaceutical or biopharmaceutical industries.
- Knowledge and Interpretation of FDA/EMEA requirements applicable to the pharmaceutical or biopharmaceutical industries. Ability to apply CGMP regulations and guidelines to all aspects of qualification activities.
Key Competencies Required
- Excellent interpersonal skills
- Ability to operate as part of a team is critical and also the ability to work alone as required
- Customer focus
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem solving skills
- Results and performance driven
- Adaptable and flexible
For further information on this Validation Engineer role in Limerick please contact Anna Carty on 086 8168298 / email@example.com
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