When you are part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals. Location/Division Specific Information
Greenville, NC How will you make an impact?
This is a sterile filling Lead role and not to be confused with formulation.
Carry out/lead the operational plan to meet the production schedule. Lead operation personnel to produce high quality pharmaceutical products according to schedule, cost and quality standards, while maintaining employee engagement, safety, performance, and ensuring adherence to all regulatory control and documentation procedures. The schedule for this role is a 12 hour shift (6p-6a) on a 2-2-3 schedule. A typical schedule would be work Monday and Tuesday, off Wednesday and Thursday, work Friday, Saturday, and Sunday. Then off Monday and Tuesday, work Wednesday and Thursday, and off on Friday, Saturday, and Sunday.What will you do?
How will you get here?Education
- Ensure pharmaceutical products are manufactured in accordance to area SOPs
- Lead line personnel in day to day operations to ensure that product meet high quality standards and exceed all the Company's current Good Manufacturing Practices (cGMPs).
- Provide leadership to Operations by performing the following: developing and empowering staff; cultivating relationships; putting staff in a position to succeed, drive engagement, accountability, and create a climate where staff is motivated to do their best.
- Ensure that production schedule is met by distributing workload in accordance with priorities.
- Ensure production operations are properly controlled and regulatory compliance requirements are met.
- Ensure operation tasks are completed in accordance with batch documentation requirements, equipment is in good repair/within calibration and housekeeping is maintained to high standards.
- Support the company's safety program to maximize safety awareness and provide a safe work environment. Ensure each employee works in a safe and responsible manner in order to create an injury-free and incident-free workplace. Comply with all job-related safety and other training requirements.
- Complete assembly, disassembly and operation of area manufacturing equipment inside/outside the aseptic core:
- Freeze dryer (Lyo) loading/Unloading
- 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.
- Become an area subject matter expert (SME).
- Train new employees.
- Perform other duties as assigned.
- High school diploma or equivalent minimally required. Technical degree preferred
- 2-3 years of regulated manufacturing (Pharmaceutical preferred), mechanical or similar experience.
- Previous Steriles Aseptic Filling experience strongly preferred
Knowledge, Skills, Abilities
- Equivalent combinations of education, training, and relevant work experience may be considered.
- Mechanical, electrical, pneumatic and hydraulic knowledge.
- Mechanical troubleshooting (manufacturing equipment preferred)
- Aseptic Cleaning
- Equipment change part cleaning and sterilization
- Component/commodity sterilization
- Aseptic gowning/technique
- Good documentation practices
- Ability 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.
- Technical and operational knowledge of aseptic processing operations (preferred)
- Effective written, verbal, and interpersonal skills. Ability to collaborate effectively with others to achieve goals and expectations.
- Must be able to work in a fast-paced environment with demonstrated ability to prioritize and be self-directed.
- Ability to coordinate multiple activities while maintaining a high level of accuracy.
- Attention to detail.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office, manufacturing, and warehouse locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound 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.
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 75,000 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. 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.