Work Schedule

12 hr shift/days

Environmental Conditions

Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift

Job Description

COMPANY INFORMATION

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

Greenville, NC; Steriles East Division

The Drug Product Division - North 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 Lead Formulation Technician will be responsible to produce sterile injectables and work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. This colleague follows written and verbal instructions when performing the following duties. Shift hours are 6am-6pm on a 2-2-3 rotating schedule.

Key Responsibilities:

• Lead and oversee the preparation of complex formulations as well as automated filling and prep equipment ensuring adherence to precise specifications and quality standards.

• Mentor and train team members on advanced formulation, automated filling and prep equipment set-up and operation procedures, and troubleshooting methods.

• Collaborate with cross-functional teams to optimize production processes (SOP's, OJT's, and FWO) and implement continuous improvement initiatives.

• Ensure pharmaceutical products are manufactured in accordance with area SOPs and current cGMP

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

• Complete tasks vital to manufacture drug products in an aseptic filling area, including:

  • Cleaning cGMP Areas

  • Perform line changeovers

  • Parts Preparation

  • Filter Integrity Testing

  • Operating Parts Washers and Autoclaves

  • Performing Tray Loading and Unloading

  • Operating the Filling Isolator

  • General Material Handling

  • Troubleshooting Equipment Alarms

Education:

• High School Diploma or equivalent required.

• Associate’s with 1 year manufacturing experience preferred.

• Bachelor’s preferred with no manufacturing experience.

Experience:

• Minimum of three (3) years of experience in pharmaceutical, biopharmaceutical, or sterile manufacturing, four (4) years preferred.

• Equivalent combinations of education, training, and relevant work experience may be considered.

• Hands-on experience in aseptic or sterile product formulation and using SAP or other manufacturing systems strongly preferred.

Knowledge, Skills, Abilities

:

• Strong technical expertise in formulation processes and quality control

• Strong technical expertise in sterile filling and filling prep processes and quality control

• Excellent problem-solving and decision- making skills

• Demonstrated ability to lead and mentor team members

• Effective communication and interpersonal skills

• Ability to drive continuous improvement and innovation in processes

• Strong organizational and time management skills

Physical Requirements / Work Environment

• Ability to stand for extended periods (up to 12 hours per shift) and walk frequently throughout the production area

• Capable of lifting and carrying up to 25 pounds occasionally and up to 10 pounds frequently

• Manual dexterity to operate various manufacturing equipment and instruments with precision

• Visual acuity to read detailed instructions, computer screens, and equipment displays

• Ability to wear personal protective equipment (PPE) for extended periods, including cleanroom suits, gloves, masks, Grade C gowning, and safety glasses

• Work is performed in a controlled cleanroom environment with exposure to pharmaceutical ingredients and chemicals

• Must be comfortable working in an environment with strict adherence to safety protocols and contamination control procedures

• May be required to work in areas with loud equipment or machinery

• Ability to work flexible hours, including potential mandatory overtime, weekend, or holiday shifts as needed to meet production demands