À propos du poste
Summary of Position
The Validation Engineer position requires 3-5 years pharmaceutical experience in an aseptic manufacturing cGMP regulated environment. The successful candidate will have experience validating manufacturing equipment and PLC and Computer-Based control systems.
1. Prepare and execute validation protocols and final reports.
2. Proficiency with the Kaye AVS Validator (Programming, Operating, Setup etc.
3. Able to read and understand equipment PI&Ds, Electrical, Pneumatic and arrangement drawings.
4. Working knowledge of PC and PLC base control systems software and hardware.
5. Working knowledge of FDA and cGMP guidelines as related to CVQ.
6. Experience validating and qualifying, but not limited to Utilities, Distillate Systems, Syringe, Vial and
Eye Dropper Filling Machines, Autoclaves, Glassware and Vial Washers, Stability Chambers Drug
Product Storage and Cleanrooms.
7. Experience with PV and Stability studies.
Position Core Competencies
1. Ability to communicate comfortably with senior leadership.
2. Dedicated to meeting expectations of internal and external functional groups.
3. Able to communicate clearly and succinctly in a variety of communication settings and styles.
4. Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
5. Uses rigorous and logic and methods to solve difficult problems with effective solutions.
6. Maintains a conscious balance between work and personal life as to not allow one to dominate the
• AS, BS degree and/or equivalent experience in pharmaceutical related discipline.
• 3 to 5 years experiences in metrology and validation of pharmaceutical manufacturing equipment.
• Experience participating in regulatory inspections and explaining/defending work.
• General knowledge of the injectable pharmaceutical industry, sterile compounding preferred.
• Experience working in cGMP environments meeting FDA, EMA, ICH guidelines, local regulations, and
industry best practices.
Fagron offers exciting opportunities for personal and professional growth. We provide an open and truly dynamic environment which supports and encourages you to develop your skills and talents.