Senior Validation Engineer

Senior Validation Engineer

Location: Limerick National Technology Park - Hybrid working 3 days a week on site

Duration: 12 month contract

Hours: 39 per week

Imagine your next project leading the validation strategy and execution for a critical line brand retrofit and conversion program, owning end-to-end deliverables from URS to final report closure within an iconic global healthcare company.

We’re seeking a Senior Validation Engineer to lead validation strategy and execution for a line brand retrofit/conversion program covering process, equipment, automation, and computerized systems. The role owns end‑to‑end validation deliverables—URS → risk assessment → protocols (IQ/OQ/PQ) → execution → report/closure—and partners cross‑functionally with Engineering, Automation, Quality, Manufacturing, to deliver a compliant, on‑time start‑up. A CSV background (e.g., PLC/SCADA/MES/LIMS interfaces, data integrity, 21 CFR Part 11 / EU Annex 11) is required. Reporting to the Business Unit Quality Manager/Staff Validation Engineer, 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.

As a Senior Validation Engineer, you will define and execute validation boundaries for impacted systems while facilitating risk assessments to determine verification rigor and sampling plans. This will involve:

• Define validation strategies and master plans for brand change, and format conversion (equipment swaps, recipe changes, packaging format/labeling changes, utilities impacts).

• Scope validation boundaries for impacted systems: process equipment, packaging machinery, utilities, automation (PLC/SCADA/DCS), vision systems, weigh/print-apply, and data flows.

• Perform and facilitate risk assessments (FMEA, hazard analysis) to determine verification rigor and sampling plans.

• Author/execute IQ/OQ/PQ/FAT/SAT for equipment and computerized systems; develop challenge matrices and PQ strategies for new SKUs/formats.

• Coordinate vendor FAT/SAT and site integration testing; manage deviations, CAPAs, and re‑tests to closure.

• Verify 21 CFR Part 11 / EU Annex 11 controls: security, audit trails, e‑signatures, backup/restore, disaster recovery, and interface testing.

• Drive change control end-to-end: impact assessment, validation deliverables, approvals, and release.

• Produce clear, audit‑ready documentation; maintain VMPs, TM, protocols, reports, and training records.

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

• Ensure accuracy and maintenance of the Johnson & Johnson Validation Master List.

benefits.

This role offers a very competitive hourly rate.

This contract will run for 12 month contract

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 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”.