About The Job The successful candidate will have experience validating manufacturing equipment and PLC and Computer-Based control systems. Perform and document instrument calibration and validation activities on a variety of pharmaceutical manufacturing equipment and troubleshooting and repair and, process validation i.e., media fills and stability studies.
Key Responsibilities - Prepare, execute and summarize validation protocols and reports.
- Proficiency with the Kaye AVS Validator (Programming, Operating, Setup etc.
- Able to read and understand equipment PI&Ds, Electrical, Pneumatic and arrangement drawings.
- Working knowledge of PC and PLC base control systems software and hardware.
- Working knowledge of FDA and cGMP guidelines as related to CVQ.
- 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.
- Experience with PV and Stability studies.
- Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.
- Uses rigorous and logic and methods to solve difficult problems with effective solutions.
- Maintains a conscious balance between work and personal life as to not allow one to dominate the other.
Basic Qualifications- BS degree in Mechanical, Industrial, Automation, or Chemical Engineering. 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.
- Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity.
- Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis).
- Knowledge of GMP including international regulations.
- Knowledge of applicable parts of 21 CFR Part 210, and 211 regulations and guidance.
- Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.
- Good verbal and written communication skills.
What's on Offer?Fagron offers its associates competitive salaries and a wide range of benefits including a 401(k) plan with a company matching contribution; medical, vision and dental; health savings account (HSA); holiday/paid time off.
At Fagron, you'll find plenty of chances to grow - both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.
