Senior Validation Engineer

Senior Validation Engineer (Facilities)

Location: Limerick

Working mode: Hybrid 3 days on-site and 2 WFH (occasional requirement to be on-site 5 days per week)

Duration: 12 months

Hours: Full-time, 39 hours per week

Imagine your next project managing facilities validation activity and supporting qualification across critical manufacturing lines and facility upgrades in a hands-on technical validation engineering role to ensure work is being completed to support production output.

This role is responsible for establishing and ensuring adherence to standardized validation best practices, whilst ensuring that company and external regulatory, quality, and compliance requirements are met.

roles and responsibilities

• Support qualification from IQ through PQ for new product Aurora on Line 53 and Line 83.

• Commission and qualify equipment, utilities including, nitrogen, compressed air, and Deionised water systems for facilities and utilities upgrades.

• Draft and physically execute validation protocols.

• Participate in weekly cross-functional core team meetings for capital projects and new line installs/retrofits.

• Commissioning and Qualification of critical utilities including but not limited to: DI Water, Compressed Air, Nitrogen.

• Commissioning and Qualification of equipment and qualification of laboratory equipment.

• Commissioning and Qualification documentation generation, review and approval, where appropriate including: Validation Project Plans, FMEAs/Risk Assessments, User Requirement Specification, Functional Design Specification, Factory Acceptance testing, Site Acceptance Testing, Commissioning Test Plans, IQ, OQ and PQ protocols and reports, and Investigations.

• Review of computer system validation documentation for upgrade to laboratory equipment software and utility PLCs.

• Responsible for supporting the activities of Operations / Engineering / Information Management in building product Quality into products and assuring compliance to the pertinent regulations while at the same time attaining operational effectiveness.

• Work with the various departments/groups in development and execution of validation activities associated with new equipment/product or I.M. system upgrades.

• Designs and develops validation documentation to support business continuity, new process/product introductions and process improvement requirements.

• Implementation and co-ordination of the change control process promotes timely approval of all supporting documentation.

• Implement J&J policies and procedures.

how to succeed

• Minimum 6 years of hands-on validation experience (drafting and executing protocols).

• Strong background in facilities and utilities validation.

• Experience with commissioning and qualification of equipment, compressed air, and ionised water systems.

• Desirable: Experience with digital validation documentation software (e.g., KNEAT).

• Third Level Degree / Bachelor's degree from accredited college in relevant science and / or engineering discipline.

• Very good interpersonal, communication and presentation skills, along with an ability to deliver on targets and deadlines.

• Proficient in the use of MS Office.

• Be very familiar with the relevant regulatory standards (F.D.A. - Quality System regulations, ISO 13485) applicable to the manufacture of Class III medical devices to Global markets.

• Have good knowledge of statistical techniques in the use of problem solving/ data analysis.

• Have a proven track record in development/execution of Validation programs in areas of Equipment, Process Information management.

• Ability to demonstrate standards of leadership - Managing Complexity/Credo Values/ Innovations/Customer focus.

• Flexible.

• Team Player.

• Good Influencing Skills.

• Project Management Skills.

• Good generalist.

benefits

This role offers a very competitive hourly rate. This contract will run for 12 months initially.

you are welcome here

Johnson & Johnson Vision 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 or LinkedIn InMail - you must apply direct to this advert.

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”.