Senior Validation & CSV Engineer Lead

Senior Validation & CSV Engineer Lead

Location: Johnson & Johnson, University of Limerick Campus, International Business Centre - Site based

Travel: You will also be traveling international expected once a month

Duration: 12 months

Hours: 40 hours

Department: Engineering Technology Development

The Senior Validation & CSV Engineer is responsible for leading validation teams' efforts for systems and processes to ensure compliance with industry standards and regulatory requirements. This role involves leading validation activities, developing validation strategies, executing test plans, analyzing data, and providing technical expertise to cross-functional teams. The ideal candidate will have extensive experience in validation leadership, methodologies, strong analytical skills, and a proactive approach to problem-solving.

The assigned resource will be based in Limerick, Ireland, as part of a global projects team. The finalized automation solution will be cited in Johnson & Johnson, Surgical Vision, Anasco, Puerto Rico. This role involves assisting the site in transitioning from a semi-manual process to a fully automated process in collaboration with our automation tooling solution providers.

JJV is committed to improving and restoring sight for patients worldwide. Since debuting the world’s first disposable soft contact lens in 1987, it has been helping patients improve their sight through its world-leading ACUVUE® Brand Contact Lenses. In 2017, J&J diversified into cataract surgery, laser refractive surgery (LASIK), and consumer eye health, now serving more than 60 million patients a day across 103 countries with its eye health portfolio. The company fosters a diverse culture, celebrates the uniqueness of employees, and is committed to inclusion. Proud to be an equal opportunity employer.

roles and responsibilities

• Provide full technical oversight, actively leading the overall validation & qualification of equipment and processes in collaboration with colleagues in Añasco.

• Lead, support, guide, and coordinate validation activities with team members to ensure adequate resource assignment, task prioritization, and progress monitoring according to schedule.

• Collaborate with Manufacturing Engineering, Operations, Quality Assurance, and Regulatory teams to define validation requirements.

• Support Regulatory Affairs with submissions to regulatory bodies and associated inquiries.

• Actively guide the team in the transition from semi-manual to automated validation methodologies, including the development of necessary validation and CSV documentation.

• Develop and implement validation protocols (IQ, OQ, PQ) for equipment, processes, and systems.

• Implement and coordinate the change control process, promoting timely approval of all supporting documentation.

• Ensure compliance with industry regulations such as FDA, GMP, or other relevant standards.

• Design and execute test plans, analyze results, and document findings in technical reports.

• Provide technical leadership in troubleshooting validation-related issues and drive continuous improvement initiatives.

• Maintain detailed documentation of validation activities and ensure traceability of validation data.

• Mentor junior engineers and team members in validation methodologies and best practices.

• Collaborate with subject matter experts to trace the defined user requirement specifications (URS) throughout the equipment qualification process (e.g., FDS, DDS, FAT/SAT, and IQ/OQ/PQ).

• Use risk analysis tools and generate and close discrepancies, deviations, and failure investigations.

• Raise and manage change requests, driving the change from its inception through the change control process to closure.

• Train personnel on Good Documentation Practices (GDP) and validation requirements.

how to succeed

Required Qualifications & Experience:

• Bachelor’s or master’s degree in engineering, Science, or a related field.

• Minimum of 5-7 years of experience in validation engineering, preferably in medical devices.

• Strong understanding of validation principles, regulatory requirements (e.g., FDA 21 CFR Part 11, ISO 13485, GMP), and statistical analysis tools.

• Hands-on experience with test methodologies, software validation, and process validation.

• Strong analytical skills and problem-solving abilities.

• Excellent communication and project management skills. International collaboration experience is desired.

• Ability to work independently and lead validation efforts in a fast-paced environment.

Preferred Qualifications:

• Certification in validation, Six Sigma, or quality management systems (e.g., ASQ, CQE).

• Expert in Microsoft applications (e.g., Word, Excel, PowerPoint Etc.).

• Experience with automation validation and software tools such as ETQ reliance‘s change management system, QUMAS quality and compliance management systems.

• Prior experience and familiarity with Johnson & Johnson day-to-day applications and procedures within the medical device field of expertise is a distinct advantage.

• Familiarity with Lean Manufacturing and Continuous Improvement methodologies.

• Experience working in cross-functional teams and leading validation projects.

Work Environment:

• Office based in the University Campus, Limerick and manufacturing environment.

• May require travel to supplier or customer locations for face-to-face meetings and/or validation activities.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months and has a strong chance of extension. 

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Vision

Johnson & Johnson Vision brings together cutting-edge insights, science, technology and people. We partner with eye care professionals and help more people around the world preserve and restore sight. Our portfolio includes the best selling contact lens brand in the world, ACUVUE®, plus consumer eye health solutions, dry eye treatments, refractive (Lasik) and cataract products. Contribute to the next healthcare breakthrough, create a world connected by SIGHT™ with your next project at Johnson & Johnson Vision. 

application process

• We are looking to process the first round of applications within the next 2 working days.

• We do not accept applications via email. 

• The pay rate for this role will depend on how you are paid. 

• PAYE, LTD & Umbrella options are available. 

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.