Sr. Formulation Technician (12hr nights, D shift, 2-2-3 rotation) [Remote]

JOB DESCRIPTION

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, Loud Noises (Equipment/Machinery), 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

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.

Location/Division Specific Information:
Greenville, North Carolina/Steriles East

How Will You Make an Impact?:

As a Sr Formulation Technician in our Greenville facility, you will play a crucial role in the development and production of sterile injectable drug products. Your expertise will contribute directly to bringing life-saving medications to patients worldwide, ensuring the highest standards of quality and safety in pharmaceutical manufacturing. Shift hours are 6pm-6am on a 2-2-3 rotating schedule.

A Day in the Life:

• Start your day by reviewing production schedules and preparing the clean room environment for sterile filling activities, including area cleaning and batch record review. Throughout the day, maintain detailed documentation of all processes and conduct in-process quality checks to ensure compliance with cGMP standards.

• Participate in a cross-functional team meeting to discuss upcoming production schedules, training, and Filling Work Orders revisions. Analyze filling operations data and contribute insights to optimize processes for efficiency and quality. Troubleshoot any issues that arise during the manufacturing process, working closely with quality assurance and engineering teams. Mentor junior technicians, sharing your expertise and ensuring adherence to safety protocols and standard operating procedures (SOPs) in the sterile manufacturing environment.

• Engage in continuous improvement initiatives by participating in Lean Six Sigma projects aimed at enhancing production efficiency and reducing waste. Conduct end-of-batch reviews, training of new colleagues, and act as operations SME engaging in opportunities for process improvements. Stay updated on industry regulations and best practices, attending training sessions and sharing knowledge with your team to maintain Thermo Fisher Scientific's position at the forefront of sterile drug manufacturing

Education:
High school diploma or equivalent required.

Experience:

• Required: Minimum of 2 years of work experience in a manufacturing, operations, production, lab setting or related field

• Preferred: Experience in a cGMP environment

• Preferred: Experience working in a clean room environment

• Preferred: Experience operating complex, technical, or fast paced manufacturing systems

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

Knowledge, Skills, Abilities:

• Demonstrated knowledge of cGMP regulations and aseptic techniques required for sterile drug manufacturing. Proficiency in following complex SOPs, Work Instructions, and maintaining detailed documentation of manufacturing processes.

• Strong analytical and collaborative problem-solving skills with the ability to troubleshoot issues in real-time during the production process. Excellent attention to detail and ability to maintain focus in a fast-paced environment.

• Proficient in using various operations filling equipment and machines relevant to pharmaceutical filling operations, such as Debaggers, Isolator filling machines, sterilizers, cappers, and Lyophilizers. Strong communication skills with the ability to effectively collaborate with cross-functional teams and mentor junior technicians.

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