Jobs

Ensures 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 changeover’s 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.

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.