Job Title: Validation Engineer
We are seeking a highly skilled Validation Engineer to join our client's team in Waterford, Ireland.
The Role:
Key Responsibilities:
* Design, execute and report on PV/Process Performance Qualifications.
* Develop and implement validation studies for equipment, systems and processes.
* Provide technical interpretation and guidance on current US FDA and EU validation requirements.
* Maintain validation documentation throughout the validation lifecycle.
* Participate in external regulatory inspections and provide support.
* Troubleshoot validation issues associated with projects, process development, etc.
Requirements:
* Degree in Science (Chemistry, Microbiology or Pharmacy preferred) or Engineering (Chemical/Mech/Elec).
* Previous validation/product development experience is highly advantageous.
* Knowledge of Process Validation regulations, current industry practices and guidelines.
* Familiarity with GAMP, ISPE Baseline guides, AAMI/ANSI, PDA and ISO guidelines.
* Excellent understanding of relevant quality and compliance regulations.
* Able to execute projects to plan and possess good communication skills.
* Experience with MS Project and SPC packages is an advantage.
About Us:
CareerWise Recruitment is a specialist recruitment agency operating in multiple locations across Ireland. We have offices in Cork, Shannon, Galway, Mayo and Dublin and specialize in recruiting management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.