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

As part of the Thermo Fisher Scientific team youll 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 worlds 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-upoperates 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 recordslogbooksand controlled forms.

• Complete assemblydisassemblyand 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

• Pipingchangeoverson 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 Is) Integrity Intensity Innovation and Involvement.

• General mechanical electricalpneumaticand hydraulic troubleshooting (manufacturing equipment preferred)

• Knowledge ofAseptic CleaningandAseptic gowning/technique

• Equipmentchangepart cleaning and sterilization

• Component/commodity sterilization

• Knowledge ofGood documentation practices

• Good written and oral communicationAttention 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.