Validation Engineer - Part Time
Location: Tullamore Co. Offaly
An exciting opportunity for a part-time Validation Engineer has arisen in Tullamore, Co. Offaly. The role consists of 20 hours per week on a contract basis and will consist of working in office and remotely. The successful candidate will be part of a team responsible for driving highly disciplined project execution to meet all safety, quality, service, delivery and cost requirements.
You will have key validation responsibilities on assigned business, new product introductions, sustaining materials, OPEX (Continuous improvement and cost reduction), Compliance and Quality related projects.
- Support projects and initiatives across the plant where required, ensuring key deliverables are achieved in a timely manner and liaising with internal and external customers.
- Ongoing drive to improve overall site quality performance by use of root cause analysis tools and techniques, with a specific focus on reducing customer complaints.
- Support reporting methodologies for CPK, PPK metrics for the top product codes at the plant. This may include the implementation of SPC.
- A degree in Engineering/Technical discipline with minimum 3 years relevant engineering experience.
- Risk management training to ISO14971:2012 is desirable.
- Project management training is advantageous.
Skills and Competencies:
- Experience of working within a regulated industry with knowledge of MDD, ISO 13485 (QM Systems), GMP Pharmaceutical guidelines, FDA, cGMP, and Risk Management (ISO 14971).
- Experience working in a quality engineering role with active involvement within a manufacturing floor, preferably in a medical device setting.
- Experience in working on projects from conception to completion, resulting in significant cost savings and process improvements.
- Analytical, data and systems driven approach to problem solving.
Ability to work cross-functional teams, including production, quality and manufacturing engineering.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.