Manufacturing Technician II - Sterile Injection - 12-Hr Day Shift 2-2-3
About The Position
The Manufacturing Technician II (Compound/Fill/Finish) assists with manufacturing sterile injectable pharmaceutical products in vial and syringe configurations for clinical and commercial distribution. The role executes advanced compounding, filling, and finishing production tasks using aseptic isolator technology and single-use components, and requires technical expertise, troubleshooting ability, and a focus on quality and GMP compliance. The technician operates manufacturing equipment according to SOPs and batch records, follows cGMP and Good Documentation Practices, uses required PPE and gowning techniques, and follows leadership and peer direction to meet production goals. The position is 100% on-site on a 12-hour rotating 2-2-3 day shift, 7:00 a.m. to 7:00 p.m. Occasional hours outside the scheduled shift, 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.
- 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 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 when required.
- 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 operating capacities from batch to batch.
- Ability to meet the described physical demands, including standing, walking, climbing or balancing, stooping, kneeling, crouching or crawling, and lifting 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.
- 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.
Responsibilities
- Learn and execute manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling in isolators, and visual inspection.
- Become a subject matter expert on compounding and filling processes and equipment.
- Perform production processes according to SOPs, batch records, and quality standards, and contribute to deviation prevention to maintain product quality.
- Conduct in-process and end-of-process sampling and quality checks.
- Identify inefficiencies and escalate them to area supervision in real time to support continuous process improvement.
- Maintain accurate, legible production documentation and escalate recommendations for document revisions.
- Complete required training on time and comply with cGMP and other company training requirements.
- Demonstrate technical ability in general manufacturing technologies and use technologies according to SOPs and cGMPs.
- Perform in-process sampling, weight checks, component counting, and basic math calculations.
- Perform in-process inspection and finished-product visual inspection.
- 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 lead by example in supporting a safety-first culture.
- Perform other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
