Formulation Tech II

at  Thermo Fisher Scientific

JOB DESCRIPTION

Job Title: Formulation Technician II (Steriles Filling)
Shift: 12 Hr Night Shift

GROUP/DIVISION SUMMARY

The Drug Product Division - South America (DPD-NA) is one of the five divisions that make up the Pharma Services Group. We are made up of approximately 4400 colleagues across six sites who specialize in taking sterile injectable and oral solid dose drug products from development to commercialization.

POSITION SUMMARY

The Formulation Tech II sets-up, operates, and maintains classified environments along with manufacturing equipment for filling pharmaceutical products.

QUALIFICATIONS:

• High school diploma or equivalent required (Biowork certificate or Technical degree preferred), and 2 years of regulated manufacturing (Pharmaceutical preferred), mechanical or similar experience required, or
• Associates degree in Science, Engineering, or similar area of study and 1 year of of regulated manufacturing (Pharmaceutical preferred), mechanical or similar experience required, or
• Bachelor’s degree in Science, Engineering, or similar area of study and no experience required.
• Demonstrates the Thermo Fisher values (The Four I’s) – Integrity, Intensity, Innovation, and Involvement.
• General mechanical, electrical, pneumatic and hydraulic knowledge. Mechanical troubleshooting (manufacturing equipment preferred)
• Knowledge of Aseptic Cleaning and Aseptic gowning/technique
• Equipment change part cleaning and sterilization
• Component/commodity sterilization
• Knowledge of Good documentation practices
• Good written and oral communication, Attention to detail while maintaining a quality product
• Basic math skills
• 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.

PHYSICAL REQUIREMENTS:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium weights of 25-50 pounds; occasionally pushing and pulling 50-100+ pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time. Ability to climb stairs and ladders. Full range of motion in upper and lower extremities.

• 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.
• Train new employees.