-
Job Description
Validation Engineer required to work with a biotech company in Clare, Ireland, to prepare, schedule, and execute commissioning, qualification, and validation protocols.
The role involves leading risk assessments for process and equipment, developing system impact assessments, validation plans, protocols, and reports, and executing commissioning and validation of manufacturing equipment and processes.
Key responsibilities include:
- Developing protocols for validation projects using a risk-based approach that meets regulatory requirements and industry practices.
- Reviewing, analyzing, and interpreting system performance data for completed validation and preparing final report packages.
- Investigating deviations, writing investigation reports, and creating summary reports.
- Managing equipment vendors to get vendor qualifications scheduled and executed.
Requirements:
- BSc/MSc or BEng/MEng in Engineering or related discipline.
- 5-7 years minimum in validation, quality systems, operations, engineering, or any combination thereof.
- Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
Career Wise Recruitment is a specialist recruitment agency established in 1999, providing career opportunities in the life sciences, ICT, engineering, food, and agri sectors.