My client is a new start-up biologics facility based in Waterford.
They are looking for a Validation Engineer to join their operations department.
Reporting into the Senior Director, Operations, you would be responsible for implementing new validation procedures and structures, and being a key member of the development of the site.
As Validation Engineer you will;
- Develops and writes commissioning, qualification and validation documents following established standards and templates
- Performs and assists with execution of validation protocols (IQ, OQ, PQ) associated with the start-up, and with the on-going re-validation of equipment and processes
- Present validation approach and study results to peers and managers
- Performs walk-down and verification of system drawings (i.e., P&IDs, as-builts, etc)
- Ensures projects are managed in conjunction with all company and regulatory requirements (Health & Safety, cGMP, construction, environmental etc).
- Provide technical assistance on current US FDA and EU validation requirements for aseptic processing and sterilisation
- Responsible for review of all design deliverables from the Engineer including drawings, datasheets, specifications and engineering lists
Education and Experience;
- Bachelor's degree (or equivalent) in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical)
- At least 12+ years relevant experience in a pharmaceutical manufacturing environment, with at least 6+ years' experience in a comparable Validation Engineering role
- Must have experience working in a sterile manufacturing environment
This is an excellent opportunity to join a great company and support their development in Waterford.
Not sure yet? No CV ready? Give me a call on 018883477 to discuss further!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales
Contact Name: Ciana Croker