Senior Process Engineer - Cork - ref. n14636919

This role is ideal for someone with strong attention to detail, excellent planning skills, and a solid background in regulated manufacturing environments. The role is fully onsite.

Key Responsibilities:

• Lead and support revalidation efforts for production equipment
• Develop and execute relocation protocols for a range of machinery
• Create and maintain detailed IQ documentation using existing templates
• Participate in and support equipment moves within the facility
• Ensure compliance with internal validation procedures and regulatory standards
• Collaborate with cross-functional teams to complete documentation efficiently and accurately
• Leverage prior experience in authoring technical and validation documents
• Proactively resolve issues and ensure smooth execution of revalidation processes

Equipment Scope May Include:

• CNC machines
• Coating machines
• Packaging equipment
• Utility panels
• Other production and manufacturing assets

Ideal Candidate Profile:

• Degree-qualified in Engineering (Level 7 minimum; Level 8 preferred)
• Proven experience in equipment validation, revalidation, and technical documentation
• Strong background in authoring validation and commissioning documentation
• Solid understanding of GMP requirements in medical device or similarly regulated industries
• Detail-oriented, organized, and capable of independently driving documentation through to completion
• Strong communication skills and ability to work within a small, focused team