Are you a driven engineer seeking a new challenge within a dynamic cGMP regulatory environment? Our client's site in Carlow is looking for talented individuals to support various critical aspects of Validation, including: Sterilisation (Autoclaves, SIP), Cleaning (Parts Washer, CIP), Isolator Systems (HVAC, VHP, E-Beam), Controlled Temperature Units (Mapping), Filter Validation, and Container Closure Integrity.
As an Engineering Specialist (Validation), you'll bring your expertise to design, author, review, approve, and execute qualification/validation documentation and studies. You'll manage change controls, resolve technical issues, and collaborate with Production, Maintenance, and Quality teams. You'll also contribute to investigations, root cause analysis, and continuous improvement initiatives using Lean Six Sigma methodologies.
We're looking for individuals with:
- A relevant technical qualification in Applied Pharmaceutical/Biological/Chemical Sciences or Engineering.
- Proven experience in a comparable validation role within a GMP manufacturing setting.
- Strong knowledge in one or more of the following areas: CTU qualification, thermal mapping, Sterilisation, Cleaning, Isolator systems, Filter Validation, or Container Closure Integrity.
- Experience with exception/deviation management and change control.
- Demonstrable experience leading technical projects.
- Excellent communication, presentation, and interpersonal skills.
(Knowledge of automation systems, data systems, regulatory requirements, and sterile fill-finish processes is advantageous.)
