eFlexes Staffing and Recruitment Solutions have a very exciting new opportunity for an experienced Validation Engineer based with a Multinational Company based in Limerick City!
Job Role:
- Support the implementation of the validation strategy, based on Corporate procedures and regulatory requirements.
- Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at the local site.
- Reviewing and approving of validation documentation to ensure compliance with regulations and validation best practices.
POSITION REQUIREMENTS:
Will work within the QA Shared Services Validation Team, 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 on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.
- Representing validation at both internal and external audits.
- 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.
- Ensuring that appropriate Site Validation Listing updated and maintained as per Current Regulatory and Company Requirements.
- Reviewing and approving of Validation/Qualification Documentation.
- Working with Validation Consultants/Contractors as required ensuring that Validations are completed as per corporate and divisional procedures
QUALIFICATION / KNOWLEDGE / SKILLS:
- Bachelor of Science, Engineering or related subject with 0 to 2 years of experience in validation, or
- Masters of Science, Engineering or related subject with 0 to 2 years of experience in validation
- Excellent communication skills and attention to detail.
- Have a good understanding of engineering and machine tool fundamentals.
- High level of PC skills.
- Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.
- Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.
- Must be willing to work as part of a multi-site team, be able to travel as part of the job
- Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.
- Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
- Highly developed problem solving and strong analytical skills.
- Lean Six Sigma training a distinct advantage.
If you are interested or would like to find out more info on the role, please email
sarah.noonan@eflexes.com !
eFlexes is an equal opportunities employer
