This job was posted by https://www.kansasworks.com : For more information, please see: https://www.kansasworks.com/jobs/13698431
Who We Are
Since 1990, weve grown into a global leader in personalized medicine. Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacificand are working together to support over 200,000 customers worldwide.
From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better.
Were passionate, science-driven, and always looking for new ways to improve lives.
Explore your future atFagron Career Site.
About The Job
[The successful candidate will have experience validating manufacturing equipment and PLC and Computer-Based control systems.]{contrast="none"}[]{contrast="none"}[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.]{contrast="none"}
[Key Responsibilities]{contrast="auto"}
- [Prepare, execute and summarize validation protocols and reports.]{contrast="none"}[]{contrast="none"}
- [Proficiency with the Kaye AVS Validator (Programming, Operating, Setup etc.]{contrast="none"}[]{contrast="none"}
- [Able to read and understand equipment PI&Ds, Electrical, Pneumatic and arrangement drawings.]{contrast="none"}[]{contrast="none"}
- [Working knowledge of PC and PLC base control systems software and hardware.]{contrast="none"}[]{contrast="none"}
- [Working knowledge of FDA and cGMP guidelines as related to CVQ.]{contrast="none"}[]{contrast="none"}
- [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.]{contrast="none"}[]{contrast="none"}
- [Experience with PV and Stability studies.]{contrast="none"}[]{contrast="none"}
- [Has the functional and technical knowledge and skills to do the job at a high level of accomplishment.]{contrast="none"}
- [Uses rigorous and logic and methods to solve difficult problems with effective solutions.]{contrast="none"}
- [Maintains a conscious balance between work and personal life as to not allow one to dominate the other.]{contrast="none"}
Basic Qualifications
- [BS degree in Mechanical, Industrial, Automation, or Chemical Engineering. and/or equivalent experience in pharmaceutical related discipline.]{contrast="none"}[]{contrast="none"}
- [3 to 5 years experiences in metrology and validation of pharmaceutical manufacturing equipment.]{contrast="none"}[]{contrast="none"}
- [Experience participating in regulatory inspections and explaining/defending work.]{contrast="none"}[]{contrast="none"}
- [General knowledge of the injectable pharmaceutical industry, sterile compounding preferred.]{contrast="none"}[]{contrast="none"}
- [Experience working in cGMP environments meeting FDA, EMA, ICH guidelines, local regulations, and industry best practices.]{contrast="none"}[]{contrast="none"}
- [Working knowledge of applicable GMP regulations, particularly 21 CFR Part 11, Eudralex Volume 4 Annex 11, and current FDA/MHRA guidance on Data Integrity.]{contrast="none"}[]{contrast="none"}
- [Experience with aspects of pharmaceutical GMP regulations (e.g. quality systems, root cause analysis).]{contrast="none"}[]{contrast="none"}
- [Knowledge of GMP including international regulations.]{contrast="none"}[]{contrast="none"}
- [Knowledge of applicable parts of 21 CFR Part 210, and 211 regulations and guidance.]{contra t="none"}[]{contrast="none"}
- [Ability to handle multiple and changing priorities and tight deadlines while remaining detail-oriented.]{contrast="none"}[]{contrast="none"}
- [Good verbal and written communication skills.]{contrast="none"}
What\'s on Offer?