Manufacturing Technician III - Sterile Injection - 12-Hr Day Shift 2-2-3
About The Position
The Manufacturing Technician III (Compound/Fill/Finish) supports the manufacture of sterile injectable products in vial and syringe configurations for clinical and commercial distribution. The role performs and oversees advanced production tasks across compounding, filling, and finishing, using aseptic isolator technology and single-use components. It requires technical expertise in aseptic processes, troubleshooting, maintaining quality and GMP compliance, and operating manufacturing equipment according to SOPs and batch records. The technician also contributes to manufacturing documentation revisions and trains and coaches other technicians. This is a 100% on-site role on a 12-hour rotating day shift, following a 2-2-3 schedule from 7:00 a.m. to 7:00 p.m. Occasional hours outside the scheduled shift, including weekend work, may be required based on business needs. Domestic travel may be up to 5%.
Requirements
- High school diploma or GED.
- 4–6+ years of relevant experience, with a strong background in sterile/aseptic manufacturing or Drug Substance manufacturing.
- Prior experience in a cGMP pharmaceutical manufacturing environment.
- Prior pharmaceutical or CDMO experience.
- Ability to perform tasks with minimal oversight while providing guidance to the team.
- Excellent verbal and written communication skills and ability to collaborate in a team environment.
- Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment.
- Strong analytical, problem-solving, troubleshooting, detail-orientation, and organizational skills.
- Ability to train others effectively.
- Ability to perform basic math calculations and comprehend and apply detailed written instructions.
- Basic computer skills, including Microsoft Office, and familiarity with electronic documentation systems.
- Ability to use appropriate PPE for the product, including PAPR or supplied-air respirators when required.
- Ability to meet the role's physical demands, including regularly standing and handling materials; lifting and moving up to 25 pounds regularly, up to 50 pounds frequently, and up to 75 pounds or more with assistance occasionally.
- 20/20 vision, with or without corrective lenses, and ability to pass a color-blind test.
- Ability to wear tight-fitting respirators; facial hair may be limited to ensure proper protection.
- Ability to participate in routine medical surveillance if required by regulations.
Nice To Haves
- Associate’s or Bachelor’s degree.
Responsibilities
- Set up, operate, and maintain equipment used for dispensing, compounding, aseptic filling in isolators, and visual inspection.
- Serve as a subject matter expert on compounding and filling processes and equipment, guiding and training other manufacturing employees.
- Monitor production for adherence to SOPs, batch records, and quality standards, making real-time adjustments to maintain product quality.
- Troubleshoot and resolve complex equipment and process issues to minimize downtime and support efficient production.
- Conduct in-process and end-of-process sampling and quality checks.
- Collaborate with cross-functional teams on continuous improvement initiatives related to product quality, safety, and efficiency.
- Contribute ideas to manufacturing readiness and execution and actively support team performance.
- Assist with validation and qualification of new equipment and processes.
- Maintain accurate production documentation, complete records in real time, and escalate recommendations for document revisions.
- Follow applicable SOPs, cGMPs, safety requirements, and company training requirements.
- Perform in-process sampling, weight checks, component counting, and basic math calculations.
- Perform in-process and finished-product visual inspections.
- Clean rooms, tools, and equipment before and after use.
- Perform material handling and dispensing, compounding, and filling activities right the first time.
- Assist in other manufacturing areas as required and perform other duties as assigned.
- Stand in for the Lead during shift exchange when needed.
- Move materials throughout the facility using appropriate methods and equipment.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
