Senior Validation Engineer
Job Description SummarySupport and execution of the validation lifecycle for the Dun Laoghaire Site including design transfer and the technical aspect of the validation lifecycle to drive continuous improvement activities.
- Ensure execution of allocated validations according to the plant Validation Master Plan.
- Produce and maintain appropriate and comprehensive validation policy and procedures.
- Ensure that the design, installation and operation of Plant and Equipment have been validated in compliance with current regulatory requirements.
- Develop a strategy to ensure that the validation approach satisfies the requirements of all regulatory bodies; regulations, standards, guidance and GMP, including effective and appropriate use of process development and DOE activities
- Provide input, monitor and report compliance on the content of the Validation Master Plan in conjunction with the appropriate Primary teams, and corresponding Management Reviews.
- Write and implement validation system documentation as required.
- Ensure the review and approval of validation lifecycle documentation and ensure they are written in accordance with the company standards and procedures
- Develop and maintain processes and procedures to ensure product and process transfers are achieved efficiently
- As a member of the Quality group, to liaise with Operations, planning and Engineering groups to ensure successful validation of all manufacturing processes.
- Plant SME for Process Validation
- Draft and Approve protocols and reports as required.
- Execution of IQ, OQ and PQ on new/revised processes as required
- Local use of (BD and Unit level) Validation Toolkits
- Publish site specific progress reports as required.
- Quality of completed validations [Effectiveness, schedule adherence, minimum deviations]
- Support the creation and control PFMEA and control plans throughout product life cycle.
- Assist with Process Development, conduct DOE and MSA.
- Participate in regulatory audits and inspections.
- To link with Post Validation activities including closure of ACR and ECO (Change Control).
- Support site change control procedures.
- Any other reasonable duties which may be required by management
- A Mechanical, Electrical or similar degree in Engineering
- A minimum of 5 years high volume engineering experience in a Medical Devices.
- A minimum of 3 years validation experience
- Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt), Sampling Plans/Sizes
- Process development experience (DOE’s etc)
- Risk Analysis/Risk Management, FMEA’s, etc.
- Strong documentation skills
- Ability to work on own initiative and as part of a team.
- Strong interpersonal and communication skills.
- Process validation training and experience
- Strong technical and problem-solving skills.
Why join us?
A career at BD means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfill your life’s purpose through the work that you do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://emea.jobs.bd.com/
Primary Work LocationIRL Dun Laoghaire - Pottery Road
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