Validation Engineer

Validation EngineerPharmaceuticalsTralee, Ireland (On-Site)About PSC BiotechWho are we?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

We are seeking an experienced Validation Engineer to join an aseptic fill-finish facility in Tralee. This role is central to ensuring systems are commissioned, qualified, and validated to the highest GMP standards.

You will lead validation activities across equipment, systems, and change controls—supporting regulatory inspections, project delivery, and ongoing compliance. A strong understanding of Commissioning & Qualification (C&Q) principles is essential.

Key Responsibilities:

• Plan, execute, and approve validation protocols in line with site and global standards
• Support commissioning and qualification for new and modified systems
• Maintain validation status through structured reporting and cross-functional coordination
• Contribute to audits, inspections, and continuous improvement initiatives

Requirements:

• Degree in Engineering or Science, or equivalent experience
• Strong knowledge of GMP and validation in regulated environments
• Proven experience with C&Q processes
• Excellent communication, project coordination, and problem-solving skills

Join a high-performing team committed to quality, innovation, and operational excellence.

Apply now to make an impact where validation matters most.