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

Alcami Corporation•Morrisville, NC

1d•Onsite

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 oversees and performs advanced compounding, filling, and finishing work using aseptic isolator technology and single-use components. It requires technical expertise in aseptic processes, troubleshooting, and maintaining quality and compliance with Good Manufacturing Practices (GMP). The technician operates manufacturing equipment according to standard operating procedures (SOPs), batch records, regulatory requirements, and current Good Manufacturing Practices (cGMPs). The position also involves maintaining production documentation, contributing to document revisions, and training and coaching 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 weekends, 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 work experience in a cGMP pharmaceutical manufacturing environment.
Prior pharmaceutical or CDMO experience.
Ability to execute tasks with minimum oversight and give guidance to team members.
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 and problem-solving skills, attention to detail, and organizational skills.
Ability to train others effectively.
Ability to perform basic math calculations and read and comprehend 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 stated physical demands, including lifting materials and passing vision requirements (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 guide and train other manufacturing employees.
Monitor production processes for compliance with 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 maintain production flow.
Conduct in-process and end-of-process sampling and quality checks.
Collaborate with Manufacturing Specialists, Technical Services, Quality Assurance, Engineering, and other cross-functional teams on continuous improvement initiatives.
Contribute ideas to manufacturing readiness and execution and actively support team performance.
Assist with validation and qualification of new equipment and processes.
Maintain accurate, detailed production documentation; complete documentation in real time with minimal errors and escalate recommendations for document revisions.
Follow applicable SOPs, cGMPs, safety requirements, and other company requirements, including completing required training on time.
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 assigned work right first time in material handling and dispensing, compounding, and filling.
Provide guidance to team members and stand in for the Lead during shift exchange as needed.
Assist in other manufacturing areas as required and perform other duties as assigned.