Manufacturing Technician III - Sterile Injection - 12-Hr Night Shift 2-2-3

Alcami Corporation • Morrisville, NC

2d • Onsite

About The Position

The Manufacturing Technician III (Compound/Fill/Finish) supports the manufacturing of sterile injectable products in vial and syringe configurations for clinical and commercial distribution. The role performs advanced production tasks across sterile compounding, filling, and finishing processes using aseptic isolator technology, and is accountable for results in a fast-paced environment.

The technician operates manufacturing processing equipment according to standard operating procedures (SOPs), batch records, and current Good Manufacturing Practices (cGMPs), while maintaining quality and regulatory compliance. The position requires technical expertise in aseptic processes and single-use components, equipment and process troubleshooting, documentation, and training or coaching other technicians. This is a 100% on-site role on a 12-hour rotating night shift (2-2-3), from 7:00 p.m. to 7:00 a.m. Occasional hours outside the scheduled shift, including weekends, may be required based on business needs. Domestic travel may be up to 5%.

Requirements

• High school diploma or GED.
• 4–6 or more years of relevant experience, with a strong background in sterile/aseptic manufacturing or Drug Substance manufacturing.
• Prior work experience in a cGMP pharmaceutical manufacturing environment.
• Prior pharmaceutical or CDMO experience.
• Ability to execute tasks with minimal oversight and guide the team to support manufacturing success.
• Excellent verbal and written communication skills and ability to collaborate in a team environment and stand in for the Lead during shift exchange.
• Ability to operate, troubleshoot, and maintain complex manufacturing equipment.
• Strong analytical and problem-solving skills, attention to detail, and organizational skills.
• Ability to train others effectively.
• Ability to perform basic math calculations and read, understand, and apply detailed written instructions.
• Ability to move materials throughout the facility using appropriate methods and equipment.
• Ability to use appropriate PPE for the product, including PAPR or supplied-air respirators when required.
• Basic computer skills, including Microsoft Office, and familiarity with electronic documentation systems.
• Ability to meet the physical demands of the position, including lifting and moving materials as described in the posting.
• 20/20 vision, with or without corrective lenses, and ability to pass a color-blind test.

Nice To Haves

• Associate’s or Bachelor’s degree.

Responsibilities

• Perform complex manufacturing operations, including setup, operation, and maintenance of equipment for dispensing, compounding, filling in isolators, and visual inspection.
• Serve as a subject matter expert on compounding and filling processes and equipment, and provide guidance and training to other manufacturing employees.
• Monitor production processes for compliance with SOPs, batch records, and quality standards; make real-time adjustments to maintain product quality.
• Troubleshoot and resolve equipment and process issues to minimize downtime and maintain efficient production flow.
• 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 controlled documentation 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.
• Assist in other manufacturing areas as required and perform assigned duties.
• Perform material handling and dispensing, compounding, and filling activities right first time.
• Follow general instructions for routine work and detailed instructions for new projects or assignments.
• Lead by example in supporting a safety-first culture.
• Work occasional hours outside the scheduled shift, including weekends, based on business needs.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED