Location/Division Specific Information:
Greenville, NC/DPD
How Will You Make an Impact?:
As a Team Leader in Formulation Manufacturing , you will lead a skilled team of manufacturing technicians dedicated to producing sterile pharmaceutical products that meet the highest standards of quality and compliance. You’ll coordinate daily operations, mentor and develop team members, and help ensure that every batch meets safety and quality expectations. Shift hours are 6am-6pm or 6pm-6am on a 2-2-3 rotating schedule.
A Day in the Life:
- Own the terminal sterilization process and review paperwork to ensure completion and compliance.
- Ensure operations are performed in a safe and responsible manner striving to create an injury-free and incident-free workplace.
- Ensure pharmaceutical products in manufacturing are in accordance to Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) and other batch related activities.
- Verify and document production activities in batch records, logbooks, etc.
- Assist in troubleshooting operational and production problems in order to identify appropriate corrective actions.
- Perform the disassembly, assembly, cleaning, and operation of area manufacturing equipment. Prepare equipment and components for operations.
- Assist in the commissioning of new equipment and production areas. Assist in initial and subsequent validation of equipment and processes.
- Maintain/clean classified environments/areas.
- Communicate and work to resolve any production, quality or safety issues.
- Comply with all job-related safety, cGMP, and other department procedural requirements.
- Participate in the On the Job (OJT) training program, area safety initiatives, and area lean manufacturing initiatives.
- Train new employees.
- Perform other duties as assigned.
Education:
- High School Diploma or equivalent required
Experience:
- Required: 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:
- General mechanical, electrical/electronic, pneumatic, and hydraulic knowledge of pharmaceutical industry equipment.
- Effective verbal and written communication skills.
- Basic computer skills.
- Strong interpersonal skills.
- Ability to work independently.
- Flexibility with departmental work schedules, including overtime and all shift operations.
- Ability to achieve and maintain qualifications to work in a cleanroom environment.
- Ability to drive a fork lift and other mobile equipment to locate product and equipment as needed.
Physical Requirements / Work Environment
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.
