Manufacturing Technician I - Sterile Injection - 12-Hr Night Shift 2-2-3
On-siteMorrisville, North Carolina, United States
Job Summary
Execute sterile injectable manufacturing operations including setup, compounding, filling, and visual inspection within aseptic isolators. Operate dispensing and filling equipment while maintaining strict adherence to SOPs, batch records, and cGMP standards. Perform in-process and end-of-process sampling, weight checks, and component counting to ensure product quality and compliance. Troubleshoot production issues in real-time, document deviations, and conduct facility cleaning and sanitation for tools and equipment. Become a subject matter expert on single-use components and aseptic processes while following all safety requirements and PPE protocols.
Required Qualifications
- High school diploma or GED
- 1-2 years' work experience
- Prior work experience in a cGMP pharmaceutical manufacturing environment
- 100% on-site position
- Night Shift: 12-Hour Rotating (2-2-3), 7:00pm - 7:00am
- Ability to learn specific department procedures
- General understanding of Good Documentation Practices (GDP) and GMP
- Ability to follow directions from leadership/peers
- Ability to read and comprehend detailed written instructions
- Ability to apply instructions during execution
- Ability to move materials throughout the facility
- Ability to use appropriate PPE based on product handling requirements
- Ability to perform basic math calculations
- Ability to detect minute defects or discrepancies in product appearance
- 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
- Ability to work outside of scheduled shift based on business needs, which may include weekend work
- 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 and 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 wear appropriate personal protective equipment including safety eyewear, hearing protection, respirators/breathing apparatus, lab coats, full protective body coverings, gloves
- Ability to operate an industrial vehicle such as a forklift
- Ability to use tight-fitting respirators (limits facial hair for proper protection)
- Ability to participate in routine medical surveillance
Desired Qualifications
- Associate or bachelor's degree
- 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
- Strong attention to detail
- Excellent communication and interpersonal skills
- Basic computer skills (Microsoft Office)
- Familiarity with electronic documentation systems
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