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

Alcami Corporation•Morrisville, NC

2d•Onsite

About The Position

The Manufacturing Technician I (Compound/Fill/Finish) assists with manufacturing sterile injectable vial and syringe products for clinical and commercial distribution. The role executes production tasks across compounding, filling, and finishing processes using aseptic isolator technology, single-use components, and manufacturing equipment. It requires technical ability, troubleshooting, and responsibility for product quality and compliance with Good Manufacturing Practices (GMP). The technician operates manufacturing processing equipment according to standard operating procedures (SOPs), batch records, and applicable regulatory requirements. The position also requires following appropriate gowning and personal protective equipment (PPE) practices, learning department procedures, applying general knowledge of Good Documentation Practices (GDP) and GMP, and following leadership and peer direction to meet manufacturing goals. This is a 100% on-site position on a 12-hour rotating day shift, 7:00 a.m. to 7:00 p.m., on a 2-2-3 schedule. Up to 5% domestic travel is expected. Occasional hours outside the scheduled shift may be needed based on business needs, including weekend work.

Requirements

High school diploma or GED required.
1–2 years of work experience required.
Prior work experience in a cGMP pharmaceutical manufacturing environment required.
Excellent verbal and written communication skills and ability to work collaboratively 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 math calculations.
Ability to read and comprehend detailed written instructions and apply them during work execution.
Ability to move materials throughout the facility using appropriate methods and equipment.
Ability to use appropriate PPE for product handling requirements, including PAPR or supplied-air respirators when needed.
Strong attention to detail and ability to detect minute product appearance defects or discrepancies.
Excellent communication and interpersonal skills and 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.
Basic physical ability to perform the stated job demands, including lifting and moving materials.
Ability to meet the stated 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 preferred.
Previous experience in dispensing, compounding, aseptic filling, or visual inspection is highly desirable.
Candidates with an NC Bioworks certificate may be considered without manufacturing experience.
Basic computer skills, including Microsoft Office, and familiarity with electronic documentation systems preferred.
Ability to operate an industrial vehicle such as a forklift, as job duties may require.

Responsibilities

Learn and execute manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, aseptic filling, and visual inspection.
Develop subject matter expertise in compounding and filling processes and equipment.
Perform production processes in accordance with SOPs, batch records, and quality standards, escalating deviations as appropriate to maintain product quality.
Conduct in-process and end-of-process sampling and quality checks.
Identify process inefficiencies and escalate them to area supervision in real time to support continuous improvement.
Maintain accurate, legible production documentation and escalate recommendations for document revisions that may reduce errors.
Complete required company training on time and comply with cGMP and other applicable requirements.
Use general manufacturing technologies in accordance with SOPs and cGMPs.
Perform in-process sampling, weight checks, component counts, and basic mathematical calculations.
Inspect products during processing and visually inspect finished products.
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, including weekends, as business needs require.
Perform other duties as assigned.