Job Title: Senior Validation Engineer
Location: Carlow, Ireland
Contract Length: 12 months
Pay Rate: €40 – €45/hour
Work Structure: Monday - Friday, 39 hours/week
The Role
Join a leading pharmaceutical company as part of its exciting expansion in Carlow, Ireland. You’ll play a pivotal role in transitioning a new state-of-the-art facility from the construction phase to a fully operational site, delivering life-saving treatments to patients globally. This opportunity will allow you to apply your experience and leadership in a dynamic environment while contributing to a critical phase in the site's development.
Responsibilities
* Provide hands-on support and oversight for commissioning, qualification, and validation (CQV) activities.
* Act as a subject matter expert (SME) for validation processes and equipment.
* Collaborate with cross-functional teams to align validation strategies with regulatory requirements.
* Manage and coach validation engineers within assigned areas.
* Support regulatory submissions and liaise with regulatory bodies as needed.
* Oversee change management processes for equipment and systems.
* Drive continuous improvement using Lean Six Sigma and other problem-solving tools.
About You
* You are an experienced professional with a minimum of 6 years in CQV/QA/QC/validation within the pharmaceutical or biotechnology industries. You are self-motivated, results-driven, and passionate about delivering excellence.
* Minimum 2 years process equipment C&Q/ QA/ Validation experience on Greenfield / Brownfield, Large Scale Project or new facility introduction.
Essential Qualifications and Skills:
* Bachelor’s degree in Pharmaceutical, Biological, Chemical Sciences, Engineering, or a related field.
* Strong understanding of GMP and regulatory requirements (e.g., ASTM E2500, Eudralex, FDA, ISPE).
* Demonstrated expertise in commissioning and qualifying process equipment, including sterile processing technologies.
* Proven track record in delivering validation projects in a highly regulated environment.
* Excellent problem-solving, communication, and leadership skills.
Preferred Skills:
* Experience with drug product filling, glass handling, and single-use technologies.
* Knowledge of cleaning and process validation for biologics.
* Project management experience and familiarity with tools like DeltaV.
* Regulatory submission and inspection experience.
Why Join Us?
* Work with a globally recognised pharmaceutical leader dedicated to improving lives.
* Be part of a ground-breaking project and gain invaluable experience in a state-of-the-art facility.
* Opportunities to grow and advance your career in the pharmaceutical industry.
Ready to contribute to life-changing treatments?
Apply now and take your career to the next level!
Please note: You must be able to work in the EU without restriction or sponsorship to be eligible for this role.
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