Validation Engineer (Med Device Cleanroom)
Cleanroom Validation Engineer
My client is Waterford based Medical Device company with exceptions growth opporunity within the organization! I’m pleased to be offering a new role for an experience Medical Device Cleanroom Validation Engineer to join on a permanent basis.
Duties of the role:
- Serve as a subject-matter expert on validation activities during regulatory agency inspections
- Support NPI team in the execution of Performance Qualification (PQ) for clean room processes as per the project schedule.
- Involved with conducting investigations into non-conformances and customer complaints, performing internal audits, preparing SOP’s and templates, assisting in Validations and troubleshooting Quality issues.
- Responsible for planning and execution of Periodic Review and Revalidation activities for clean utilities, systems and equipment.
- Support deviation investigations throughout the manufacturing site.
- Manage several projects simultaneously and coordinate multiple, changing deadlines
- Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up related CAPA’s as required.
- Create concise and accurate on-time technical reports. Clearly communicate results internally and to customer through the use of quality tools and statistical techniques.
- SME for appropriate statistical techniques to monitor process performance such as SPC, Cp, Cpk, R&R analysis, sampling techniques and other statistical techniques.
- Creates and evaluates metrics to drive tangible quality improvement through the team.
Requirements of the successful candidate:
- Degree in Engineering; Mechanical/Manufacturing/Process or similar
- 5 years’ experience in Validation Engineering; Exposure to SPC and validations
- Knowledge of Reg requirements ISO 9001-13485 CFR 820 is essential
- Knowledge of cleanroom environmental monitoring
- Knowledge of ISO 31000 & ISO14644
- Experience in the use of techniques such as Design of Experiments, Gauge R&R, Test Method Validation, sample size justification to support design changes, validations, deviations
For further information on this Validation Engineer role, please contact Marchon Monroe on 086 044 9473/ email@example.com
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