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

Alcami Corporation•Morrisville, NC

13d•Onsite

About The Position

The Manufacturing Technician II (Compound/Fill/Finish) supports the manufacture of sterile injectable pharmaceutical products in vial and syringe configurations for clinical and commercial distribution. The role executes advanced compounding, filling, and finishing work using aseptic isolator technology, single-use components, and manufacturing equipment. It requires technical skill in aseptic processes, troubleshooting, and maintaining quality and compliance with Good Manufacturing Practices (GMP). The technician operates equipment according to standard operating procedures (SOPs), batch records, regulatory requirements, and current Good Manufacturing Practices (cGMPs). The position also requires appropriate manufacturing techniques and PPE gowning, general knowledge of Good Documentation Practices (GDP) and GMP, and the ability to learn department procedures and follow direction to meet production goals. This is a 100% on-site role on a 12-hour rotating 2-2-3 night shift, from 7:00 p.m. to 7:00 a.m. Occasional hours outside the scheduled shift may be needed for business requirements, including weekend work. Up to 5% domestic travel is expected.

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 collaborate in a team environment.
Ability to operate, troubleshoot, and maintain complex manufacturing equipment.
Ability to apply job skills, company policies, and SOPs to varied 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 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 where required.
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 batch-to-batch operating capacities.
Ability to meet the physical demands described, including standing, walking, reaching, climbing or balancing, stooping, kneeling, crouching or crawling, and lifting or moving materials of varying weights; items over 75 pounds may be moved with assistance.
Required vision abilities include close, distance, and color vision, peripheral vision, depth perception, and ability to adjust focus; must have 20/20 vision with or without corrective lenses and pass a color-blind test.
Ability to work around moving mechanical parts, fumes or airborne particles, and toxic or caustic chemicals, and to wear required PPE.
Tight-fitting respirators may limit facial hair; routine medical surveillance may be required.
Ability to use a body harness and lanyard for some elevated tasks and operate an industrial vehicle such as a forklift if required.

Nice To Haves

Associate or bachelor's degree preferred.
2–5 years of work experience preferred.
Previous experience in dispensing, compounding, aseptic filling, or visual inspection is highly desirable.
Candidates with life sciences or engineering degrees may be considered without manufacturing experience.
Basic computer skills, including Microsoft Office, and familiarity with electronic documentation systems preferred.
Ability to effectively 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, and contribute minimally to deviations to maintain product quality.
Conduct in-process and end-of-process sampling and quality checks to ensure products meet standards.
Identify inefficiencies and promptly escalate them to area supervision to support process improvement.
Maintain accurate, legible production documentation and escalate recommendations for document revisions that could 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 counting, and basic math 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 the first time.
Follow general instructions for routine work and detailed instructions for new projects or assignments.
Follow safety requirements and promote a safety-first culture.
Work occasional hours outside the scheduled shift as business needs require, which may include weekends.
Perform other duties as assigned.