Metal Process Validation Engineer
Validation Engineer
Position Summary:
Support validation projects and initiatives as per business needs. Coaching and guiding multifunctional engineering teams to effectively establish and meet the validation and process development corporate requirements. Responsible for local validation teams in terms of technical expertise and definition of best practices. High visibility and high-risk decision-making role.
Responsible for validation-related activities, including, but not limited to the following:
- Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
- Participating within the Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
- Participating in both Corporate and Local Validation Teams to discuss/give feedback, and approve revisions to Validation Procedures.
- Representing validation at both internal and external audits.
- Guides the definition of validation strategies for highly complex validation projects (multiple sites).
- Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.
- Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.
- Use quality engineering tools, statistical methods, design development methods, process development/control methods, and process verification/validation planning to build quality into new and existing products.
- Working closely with product transfer, NPI, NPD, and AO teams.
- Lead validation continuous improvement projects.
- Implement lean and Six Sigma initiatives to assigned projects and lead teams to apply these methodologies.
What you will need:
- Proficiency in Medical Device Validation and QA is needed.
- Bachelor of Science, Engineering, or related subject with 4+ years of experience in validation GMPs.
- Experience in Validating Metal Processes.
- Self-starter with demonstrated efficient work methods, analytical & problem-solving skills, and ability to handle multiple tasks in a fast-paced environment.
- Working knowledge/experience of Risk Based Techniques, i.e., FMECAs, FTAs, RMF, etc.
- Highly developed problem-solving and strong analytical skills.
- Lean Six Sigma training is a distinct advantage.
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