Formulation Technician II
Found in: Talent US C2 - 3 weeks ago
Ensure pharmaceutical products are manufactured in accordance to area SOPs and current cGMP.
Verify and document production activities in batch records, logbooks and controlled forms.
Complete assembly, disassembly and operation of area manufacturing equipment inside/outside the aseptic core: Filler, Capper, Freeze dryer (Lyo) loading/Unloading, Trayloader, Vial Washer, SMEJA stopper processor, Equipment and component sterilizers, Filter integrity testers
Piping changeovers on the product delivery systems and CIP/SIP cycles (Filler/Stopper isolator)
Assist with initial/subsequent validation of filling equipment and processes.
General material handling
Maintain/clean classified areas. This includes but is not limited to the aseptic core.
Mechanical troubleshooting
Clean pre and post use change parts and prep for sterilization.
Participate in the On the Job (OJT) training program, area safety and Lean Manufacturing initiatives.
Train new employees.
Requirements
High school diploma or equivalent required. Technical degree preferred.
2 years of supervised manufacturing (Pharmaceutical preferred), mechanical or similar experience.
Knowledge, Skills, Abilities
General mechanical, electrical, pneumatic and hydraulic knowledge.
Mechanical troubleshooting (manufacturing equipment preferred)
Aseptic Cleaning
Equipment change part cleaning and sterilization
Component/commodity sterilization
Aseptic gowning/technique
Good documentation practices
Good written and verbal communication
Ability to use a computer
Ability and desire to learn
Stand for long periods of time
Ability to work with cross-functional teams comprised of diverse individuals.
Ability to manipulate (lift, carry, move) weights of 25-50 pounds; occasionally pushing and pulling 50-100+ pounds.
Full range of motion in upper and lower extremities.
At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and give to our singular mission—enabling our customers to make the world healthier, cleaner and safer.
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