[ref. s81651820] Morgan McKinley - Senior Validation Engineer

I am seeking a dynamic Senior Validation Engineer to join our client's team at their Carlow site. This is a fantastic opportunity to contribute to Cleaning Validation in a cGMP regulatory environment, supporting recovery and cleanability studies.

Key Responsibilities:

• Design, author, review, approve, and execute qualification/validation documentation and cycle development studies.
• Lead the execution and development of change controls.
• Resolve technical issues during study execution.
• Collaborate with Production, Maintenance, and Quality teams during Cycle Development & Performance Qualification activities.
• Provide technical input for investigations and quality notifications.
• Support continuous improvement through Lean Six Sigma methodologies.
• Ensure compliance with GMP, regulatory requirements, and global policies.
• Represent the validation team in cross-functional projects and global technical forums.
• Support regulatory audits and submissions.

Required Skills & Experience:

• Proven experience in cleaning validation (CIP, COP, TOC, ICP, swab methods).
• Relevant technical qualifications in Pharmaceutical, Biological, or Chemical Sciences or Engineering.
• Experience in deviation management, change control, and technical project leadership.
• Knowledge of regulatory requirements (Irish, European, and International Codes/Standards).
• Strong analytical, report writing, and communication skills.
• Experience in GMP manufacturing settings, equipment, and process validation.

Preferred Skills:

• Filter validation, CCI qualification, and sterilization validation (Autoclave/SIP, Dry Heat).
• Project management skills and experience with operational intelligence systems (Pi System, DeltaV).

Apply today to become part of our dedicated team, committed to delivering quality in every aspect of our work.