Formulation Technician II (12 hr days, PDS Suite 3, 2-2-3)

Work Schedule

12 hr shift/days

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Fluctuating Temps hot/cold, Laboratory Setting, Loud Noises (Equipment/Machinery), Office, Rapid flashing lights, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials, Working at heights

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

GROUP/DIVISION SUMMARY

The Drug Product Division -SouthAmerica (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

TheFormulation TechIIsets-up,operates, andmaintainsclassified environments along with manufacturing equipment for filling pharmaceutical products. Shift hours are 6am-6pm on a 2-2-3 rotating schedule.

Key Responsibilities:

• Ensures pharmaceutical products are manufactured in accordancetoarea SOPs and current cGMP.

• Verify and document production activities in batch records,logbooksand controlled forms.

• Complete assembly,disassemblyand operation of area manufacturing equipment inside/outside the aseptic core:

• Filler

• Capper

• Freeze dryer (Lyo) loading/Unloading

• Trayloader

• Vial Washer

• SMEJA stopper processor

• Equipment andcomponentsterilizers

• Filter integrity testers

• Pipingchangeover’son the product delivery systems and CIP/SIP cycles (Filler/Stopper isolator)

• Assistwithinitial/subsequentvalidation 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, areasafetyand Lean Manufacturing initiatives.

• Train new employees.

Education:

• High school diploma or equivalent required.

Experience:

• Required: Minimum of 1 year of work experience in a manufacturing, operations, production, lab setting or related field

• Preferred: Experience in a cGMP environment

Knowledge, Skills, Abilities:

• Demonstrates the Thermo Fisher values (The Four I’s) – Integrity, Intensity, Innovation, and Involvement.

• General mechanical, electrical,pneumaticand hydraulic knowledge. Mechanical troubleshooting (manufacturing equipment preferred)

• Knowledge ofAseptic Cleaning andAseptic gowning/technique

• Equipmentchangepart cleaning and sterilization

• Component/commodity sterilization

• Knowledge ofGood documentation practices

• Good written and oral communication,Attention to detail whilemaintaininga qualityproduct

• Basic math skills

• Ability to use acomputer

• Ability and desire tolearn

• Stand forlong periodsoftime

• Ability to work with cross-functional teamscomprisedof 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 lowerextermities.