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

Alcami Corporation•Morrisville, NC

6d•Onsite

About The Position

The Manufacturing Technician II (Compound/Fill/Finish) assists in manufacturing sterile injectable products in vial and syringe configurations for clinical and commercial distribution. This role performs advanced production tasks involving compounding, filling, and finishing through aseptic isolator technology, with technical responsibilities for aseptic processes and single-use components, troubleshooting, and maintaining quality and cGMP compliance. The technician operates manufacturing processing equipment according to standard operating procedures (SOPs) and batch records, follows regulatory requirements and Good Manufacturing Practices, and uses appropriate techniques and PPE gowning in manufacturing environments. The role requires learning department procedures, understanding Good Documentation Practices and GMP, and following leadership and peer direction to meet manufacturing goals. This is a 100% on-site position on a 12-hour rotating 2-2-3 day shift, 7:00 a.m. to 7:00 p.m. Occasional work outside scheduled shifts, including weekends, may be required based on business needs. Up to 5% domestic travel is expected.

Requirements

High school diploma or GED.
1–2 years of work experience required.
Prior work experience in a cGMP pharmaceutical manufacturing environment.
Excellent verbal and written communication skills and ability to collaborate in a team environment.
Proven ability to operate, troubleshoot, and maintain complex manufacturing equipment.
Ability to apply job skills, company policies, and SOPs to 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 understand 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 for 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 work independently and collaboratively in a fast-paced environment.
Flexibility to adapt to changing priorities and variable operating capacities from batch to batch.
Ability to meet the physical demands of the job, including standing, walking, climbing or balancing, stooping, kneeling, crouching or crawling, and lifting materials.
Ability to meet the stated vision requirements, including 20/20 vision with or without corrective lenses and passing a color-blind test.

Nice To Haves

Associate or bachelor’s degree.
2–5 years of work experience.
Previous experience in dispensing, compounding, aseptic filling, or visual inspection.
Life sciences or engineering degree; candidates with these degrees may be considered without manufacturing experience.
Basic computer skills, including Microsoft Office, and familiarity with electronic documentation systems.
Excellent communication and interpersonal skills, with the ability to train and certify employees.

Responsibilities

Learn and execute manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, isolator filling, and visual inspection.
Become a subject matter expert on compounding and filling processes and equipment.
Perform production processes in accordance with SOPs, batch records, and quality standards, while minimizing deviations and maintaining product quality.
Conduct in-process and end-of-process sampling and quality checks.
Identify inefficiencies and promptly escalate them to area supervision to support continuous improvement.
Maintain accurate, legible production documentation and escalate recommendations for document revisions that could reduce errors.
Complete required cGMP and other company training on time.
Demonstrate technical ability in general manufacturing technologies and use them according to SOPs and cGMPs.
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.
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 promoting a safety-first culture.
Work occasional hours outside the scheduled shift, including weekends, based on business needs.
Perform other duties as assigned.