Validation Engineer – Sterilisation & Autoclave Validation

About the role

PSC Biotech is seeking a Validation Engineer to join its Carlow site and support validation activities in a cGMP regulated environment. The role focuses on sterilisation processes, including autoclave and steam‑in‑place (SIP) systems, and will work closely with production, maintenance and quality teams.

Key responsibilities

• Design, author, review, approve and execute qualification and validation documentation and cycle development studies.
• Develop, review and implement change controls and manage technical issues during study execution.
• Collaborate with Production, Maintenance and Quality representatives for cycle development and performance qualification.
• Provide technical input for quality notifications, investigations and root‑cause analyses.
• Support continuous improvement initiatives using Lean Six Sigma methodology.
• Represent the validation function on cross‑functional projects and global technical forums.
• Ensure compliance with global policies, procedures, regulatory requirements and cGMP practices.

Required profile

• Engineering degree or equivalent qualification.
• Experience in validation of sterilisation equipment such as autoclaves and SIP vessels.
• Strong understanding of cGMP regulations and validation principles.
• Ability to work independently and engage effectively with multidisciplinary teams.

Required skills

• Autoclave sterilisation
• Steam‑in‑Place (SIP) systems
• Lean Six Sigma
• cGMP compliance
• Root cause analysis

What we offer

• Permanent contract with exposure to top pharmaceutical client sites.
• Comprehensive learning and development programmes, mentorship and career progression support.
• Diverse, multicultural work environment.