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.]{contrast="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?

Fagron Sterile Services

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