Validation Engineer
We have a current opportunity for a Validation Engineer on a contract basis. The position will be based in Cork.
The role is supporting an exciting Product Transfer project as the client looks to replicate Manufacturing processes on a new site.
Job Description:
- Responsible for validation-related activities, including, but not limited to the following:
- Providing Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.
- Developing and revising Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.
- Discussing and giving 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).
- 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.
- Implement and develop company validation process for newly acquired sites as part of the merge and acquisitions teams
- Working closely with product transfer, NPI, NPD, and AO teams.
- Lead Validation continuous improvement projects.
- Subject Matter Expert responsible for at least 2 validation specialties and being the primary support for those specialties (e.g., Computer System Validation (CSV) / Qualification of Buildings, Facilities and Utilities (BFU) / Measuring System Analysis (MSA), etc.)
Contract:
- 18 to 24 months
- Full-time hours
- On site in Cork
- Start dates early June
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