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

Alcami Corporation•Morrisville, NC

2d•Onsite

About The Position

The Manufacturing Technician I (Compound/Fill/Finish) supports manufacturing of sterile injectable pharmaceutical products in vial and syringe configurations for clinical and commercial distribution. The role executes production work across compounding, aseptic filling, and finishing processes using isolator technology and single-use components, while maintaining product quality and compliance with Good Manufacturing Practices (GMP/cGMP). The technician operates manufacturing equipment and follows standard operating procedures, batch records, regulatory requirements, and good documentation practices. Work includes equipment setup, operation and maintenance; sampling and quality checks; inspection; cleaning; documentation; and material handling. The role requires PPE gowning, attention to detail, the ability to troubleshoot equipment and processes, and collaboration with team members and leadership to meet manufacturing goals. This is a 100% on-site position on a 12-hour rotating night shift schedule (2-2-3), from 7:00 p.m. to 7:00 a.m. Occasional hours outside the scheduled shift may be required based on business needs, including weekend work. Up to 5% domestic travel is expected.

Requirements

High school diploma or GED.
1–2 years of work experience.
Prior work experience in a cGMP pharmaceutical manufacturing environment.
Excellent verbal and written communication skills and ability to collaborate in a team environment.
Ability to operate, troubleshoot, and maintain complex manufacturing equipment.
Ability to apply job skills, company policies, and SOPs to complete a variety of assignments.
Strong attention to detail and organizational skills.
Strong problem-solving and basic troubleshooting ability.
Ability to perform basic mathematical calculations.
Ability to read and comprehend detailed written instructions and apply them during execution.
Ability to move materials throughout the facility using appropriate methods and equipment.
Ability to use appropriate PPE based on product-handling requirements, including PAPR or supplied-air respirators when required.
Strong attention to detail and ability to detect minute defects or discrepancies in product appearance.
Ability to train and certify employees.
Ability to work independently and collaboratively in a fast-paced environment.
Flexibility to adapt to changing priorities and variable operational capacities from batch to batch.
Ability to meet the described physical demands, including lifting and moving materials, and the specified vision requirements: 20/20 vision with or without corrective lenses and ability to pass a color-blind test.

Nice To Haves

Associate or bachelor's degree.
Previous experience in dispensing, compounding, aseptic filling, or visual inspection.
NC Bioworks certificate; candidates with this certificate may be considered without manufacturing experience.
Basic computer skills, including Microsoft Office, and familiarity with electronic documentation systems.

Responsibilities

Learn and execute manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling in isolators, and visual inspection.
Develop subject matter expertise in compounding and filling processes and equipment.
Perform production processes in accordance with SOPs, batch records, quality standards, and cGMP requirements, and contribute to minimizing deviations.
Conduct in-process and end-of-process sampling and quality checks.
Identify inefficiencies and promptly escalate them to area supervision to support continuous process improvement.
Maintain accurate, legible production documentation and escalate recommendations for document revisions.
Complete required company training on time and comply with cGMP and other relevant requirements.
Use manufacturing technologies in accordance with SOPs and cGMPs.
Perform in-process sampling, weight checks, component counting, and basic mathematical calculations.
Perform in-process inspections and finished-product visual inspections.
Clean rooms, tools, and equipment before and after use.
Assist in other manufacturing areas as required.
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.
Follow safety requirements and lead by example in supporting a safety-first culture.
Work occasional hours outside the scheduled shift, which may include weekends, based on business needs.
Perform other duties as assigned.