Senior Project Validation Engineer is required to provide Quality Support for validation processes by market-leading health products manufacturer in Waterford.
The successful professional will provide Quality support and expertise on validation processes and documentation for manufacturing life-cycle of products.
You will join a dynamic team of professionals with various levels of expertise and work together to achieve excellence product quality.
Responsibilities:
- Provide Quality support for all validation processes & documentation as part of the transfer and or expansion of projects.
- Provide Quality support and guidance for site validations and re validations.
- Provide Quality support for all FMEA,s throughout the project lifecycle.
- Liaise with project engineering group to plan, review and witness execution of validations.
- Preparation and update of Validation strategy docs for transfer project.
- Quality approval for transfer project change requests.
- Preparation and update of applicable FMEA’s
- Review of significant changes relating to transferred equipment versus previous installations.
- Review and approval of Validation protocols for transferred/ new equipment and processes. IQ/OQ /PQ/PV.
- Provide day-to-day direction on quality assurance issues within the transfer project team.
- Review and approval of validation reports and procedures for changes/ updates to film lines.
- Control of equipment and product during validation and release of product post validation.
- Raise and follow through on CAPA’s and NC’s resulting from Equipment transfer validations.
- Work in partnership with Engineering Transfer team to ensure quality and achieve improvement initiatives within the transfer project.
- Follow Standard Operating Procedures at all times.
Requirements:
- Bachelor’s Degree in Engineering or Science or similar discipline.
- Strong analytical skills with good knowledge of applied statistics and process control Systems.
- Knowledge of Six Sigma and Lean tools.
- Experienced with the regulatory requirements of the FDA and/or ISO.
- Proactive, good communicator, self-motivated, have record of achievement and are a good team member.
- A true leader with ability to motivate & influence a core team to meet the above objective.
Our client offers an inclusive and collaborative work environment with opportunities for career growth.
Please send your CV in confidence to emer@emtechrecruitment.ie.
