A challenging opportunity has arisen for a skilled Validation Engineer to support the validation and compliance of equipment, systems, and processes in a leading healthcare manufacturing company based in Ireland.
Key Responsibilities:
* Designing, executing, and reporting on PV/Process Performance Qualifications
* Designing, executing, and reporting on validation studies for equipment, systems, and processes
* Ensuring validation studies are managed in accordance with all relevant standards and regulatory requirements
* Providing technical guidance on current US FDA and EU validation requirements for aseptic processing, lyophilisation, sterilisation, and depyrogenation
Requirements:
* Relevant degree in a scientific or engineering discipline
* Proven industry experience in a healthcare manufacturing environment, preferably within the pharmaceutical sector
* Working knowledge and practical experience with troubleshooting validation issues, as well as a strong understanding of quality and compliance regulations
This role offers the chance to support new product introductions, equipment qualification, and site requalification programs. The successful candidate will be responsible for ensuring ongoing validation and compliance of existing and new equipment, systems, and processes.
We welcome applications from anyone who meets the role requirements. Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer, exclusively supporting the Life Science sectors.