Job Title:
Validation Specialist
Description:
A validation specialist is required to work on a project for a pharmaceutical company in Waterford. The successful candidate will have experience in aseptic processing, lyophilisation, sterilisation and depyrogenation.
Key Responsibilities:
* Designing and executing process performance qualifications
* Validating equipment, systems and processes
* Providing technical guidance on current US FDA and EU validation requirements
* Maintaining validation documentation throughout the lifecycle
* Participating in regulatory inspections and supporting change control processes
* Troubleshooting validation issues
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 and industry practices
* Experience with GAMP, ISPE Baseline guides and steam/dry heat validation publications
* Familiarity with quality management systems and MS Project/SPC packages
* Excellent communication skills