Formulation Tech II

Job Title: Formulation Technician II (Steriles Filling)

Shift: 12 Hr Night Shift

Company Information

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $30 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 80,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit www.thermofisher.com.

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.

Key Responsibilities

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:FillerCapper 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.

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, orAssociates degree in Science, Engineering, or similar area of study and 1 year of of regulated manufacturing (Pharmaceutical preferred), mechanical or similar experience required, orBachelor’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 productBasic math skillsAbility 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.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific). As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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