Junior Validation Engineer

ABOUT ITW MEDICAL

ITW (NYSE: ITW) is a Fortune 200 global multi\-industrial manufacturing leader with revenue of $16\.1 billion in 2024\. The company’s seven industry\-leading segments leverage the unique ITW Business Model to drive solid growth with best\-in\-class margins and returns in markets where highly innovative, customer\-focused solutions are required. ITW’s approximately 45,000 dedicated colleagues around the world thrive in the company’s decentralized and entrepreneurial culture. www.itw.com.

ITW Medical, a division of ITW, is comprised of two highly respected brands\- Coeur and Filtertek, supplying critical filtration and flow control solutions to global OEM’s, serving Surgical, Infusion, Bioprocessing and Diagnostic Imaging end markets.

Brief Job Description:

Responsible for the compilation and execution of validation processes and documentation.

Key Responsibilities:

· Compilation of validation life cycle documentation in accordance with applicable ITWMedical procedures, applicable regulations and GAMP 5\.

· Compilation of equipment, process \& product validation documentation including; VMP, URS, FDS, DQ, pFMEA, FAT, SAT, IQ, PD, OQ and PQ.

· Execution of validation protocols and reporting validation progress to the Manufacturing Engineering Manager.

· Consult with process owner/user groups/suppliers/customers in the preparation of validation documents, risk analysis and compilation of reports.

· Actively engage in investigation \& problem solving relating to validated processes.

· Update of quality system documents affected by validations.

· Comply with GMP (Good Manufacturing Practice) requirements in daily activities.

· Comply with Health \& Safety requirements in daily activities.

· Any other duties that are necessary within the scope of the position of Validation Engineer as determined by the Manufacturing Engineering Manager.

Experience:

· Previous experience of validation and medical device/pharmaceutical manufacturing an advantage.

· Previous experience in statistical analysis an advantage.

· Have working knowledge of manufacturing and industry “best practice”, GMP and ISO Quality standards and Practices.

· Have a high level of business awareness, be action oriented complemented by the resilience to achieve challenging objectives.

· Strong interpersonal skills, an innate ability to influence and build relationships at all levels and a driving vision to create an inclusive culture of performance, continuous improvement and development.

· Must be a pro\-active self\-starter and an excellent communicator with exceptional problem\-solving skills.

Qualifications:

· Honours level degree in Engineering/Science/Quality

Pay: €35,000\.00\-€40,000\.00 per year

Benefits:

• Company pension


• On\-site parking


• Private medical insurance


• Sick pay

• Newcastle West, County Limerick: reliably commute or plan to relocate before starting work (required)

• Bachelor's (required)

• English (required)

• Ireland (required)

• Newcastle West, County Limerick (preferred)

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