Work Schedule

12 hr shift/nights

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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Will work with hazardous/toxic materials

Job Description

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 Manufacturing Operator II sets-up, operates and maintains classified environments and manufacturing equipment for filling/finishing 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, including:Filter Integrity TesterParts WasherPortions of Filling Isolator (Vial Loading, Vial Washer, Tunnel, Capper, Tray-Off)Piping changeover’s on the product delivery systems, including VHP cyclesAssist with initial/subsequent validation of filling equipment and processes.General material handlingMaintain/clean classified areas.Assist with mechanical troubleshootingClean pre and post use change parts and prep for sterilization.In-process product inspectionParticipate 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 preferred.1 year of regulated manufacturing (Pharmaceutical preferred), mechanical or similar experience required.Demonstrates the Thermo Fisher values (The Four I’s) – Integrity, Intensity, Innovation, and Involvement.Excels in a team environment.Basic math skillsAttention to detail while maintaining a quality product.Ability to perform repetitive work duties.General mechanical and electrical knowledgeGood written and oral communicationGood documentation practicesAbility to use a computerAbility and desire to learnStand for long periods of timeAbility to work with cross-functional teams comprised of diverse individuals.Ability to regularly sit, stand, walk, talk and hear; use hands to finger, handle or feel; and reach with hands and arms. Close vision and ability to adjust focus required.Regularly required to lift up to 20 pounds. May be required to lift weight of 45 pounds or more, with assistance and/or with equipment on occasion.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 extermities.

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!