Manufacturing Technician I - Sterile Injection - 12-Hr Day Shift 2-2-3
On-siteMorrisville, North Carolina, United States
Job Summary
Execute manufacturing operations for sterile injectable products, including setup, operation, and maintenance of equipment for compounding, filling, and visual inspection. Perform in-process and end-of-process sampling, weight checks, and component counting while adhering to SOPs, batch records, and cGMP standards. Become a subject matter expert on aseptic processes, troubleshoot deviations, and maintain accurate production documentation. Clean rooms, tools, and equipment before and after use, and assist with other manufacturing areas as required. Work occasional hours outside the scheduled shift based on business needs.
Required Qualifications
- High school diploma or GED
- Associate or bachelor's degree
- 1-2 years' work experience
- Prior work experience in a cGMP pharmaceutical manufacturing environment
- 100% on-site position
- Day Shift: 12-Hour Rotating (2-2-3), 7:00am - 7:00pm
- Ability to learn specific department procedures
- General understanding of Good Documentation Practices (GDP) and GMP
- Ability to follow directions from leadership/peers
- Ability to stand
- Ability to use hands to finger, handle, or feel
- Ability to reach with hands and arms
- Ability to talk or hear and smell
- Ability to walk
- Ability to climb or balance
- Ability to stoop, kneel, crouch, or crawl
- Ability to sit
- Ability to regularly lift and/or move up to 25 pounds
- Ability to frequently lift and/or move up to 50 pounds
- Ability to occasionally lift and/or move up to 75 pounds
- Ability to occasionally lift and/or move over 75 pounds with assistance
- Close vision
- Distance vision
- Color vision
- Peripheral vision
- Depth perception
- Ability to adjust focus
- 20/20 vision (with or without corrective lenses)
- Ability to pass a color-blind test
- Ability to regularly work outside of scheduled shift based on business needs, which may include weekend work
- Ability to operate an industrial vehicle such as a forklift
- Ability to use the appropriate PPE based on product handling requirements (i.e. PAPR, Supplied Air Respirator, etc.)
- Ability to read and comprehend detailed written instructions and apply instructions during execution
- Ability to move materials throughout the facility using appropriate methods and equipment
- Ability to effectively train and certify employees
- Ability to work independently and collaboratively in a fast-paced environment
- Flexibility to adapt to changing priorities and support operations at variable capacities
- Ability to readily adapt to variable operations required batch to batch
Desired Qualifications
- Associate or bachelor's degree preferred
- Previous experience in dispensing, compounding, aseptic filling, or visual inspection
- Candidates with NC Bioworks certificate
- Excellent verbal and written communication skills
- Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment
- Strong detail orientation and organizational skills
- Strong problem-solving and basic trouble-shooting ability
- Ability to perform basic math calculations
- Strong attention to detail and the ability to detect minute defects or discrepancies in product appearance
- Excellent communication and interpersonal skills
- Ability to work independently and collaboratively in a fast-paced environment
- Flexibility to adapt to changing priorities and support operations at variable capacities
- Basic computer skills (Microsoft Office)
- Familiarity with electronic documentation systems
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