Sterile Fill/Finish Technician II – Night Shift

Alcami Corporation; Morrisville (NC); In loco; USD 65.000 - 90.000; Tempo pieno

Descrizione del lavoro

Alcami Corporation is seeking a Manufacturing Technician II – Sterile Injection to join our on-site team in Morrisville, NC. You will support aseptic filling, compounding, and fill/finish operations for sterile injectable products, working with isolator technologies and GMP compliance.

The role emphasizes SOP-driven tasks, accurate documentation, safety, and the ability to troubleshoot equipment. Night shift is 12 hours, 7:00 pm to 7:00 am, with occasional weekend requirements.

Competenze

• High school diploma or GED; associate or bachelor's degree preferred.
• 1–2 years work experience required; 2–5 years preferred.
• Prior work experience in a cGMP pharmaceutical manufacturing environment required.
• Previous experience in dispensing, compounding, aseptic filling, or visual inspection highly desirable.
• Candidates with life sciences or engineering degrees will be considered without manufacturing experience.

Mansioni

• Learn and execute manufacturing operations, including setup, operation, and maintenance of equipment used in dispensing, compounding, filling (isolators), and visual inspection.
• Become a subject matter expert (SME) on compounding/filling processes and equipment.
• Perform production processes with adherence to SOPs, batch records, and quality standards, contributing minimal deviations to maintain product quality.
• Conduct in-process and end-of-process sampling/quality checks, ensuring all manufactured products meet rigorous standards.
• Identify inefficiencies and escalate to area supervision in real time to support continuous process improvement.
• Maintain accurate and detailed production documentation, ensuring legibility with minimum errors and recommend revisions to reduce errors.
• Ensure timely completion and compliance with cGMP and all relevant training requirements.
• Demonstrate technical ability in general manufacturing technologies and utilize technologies per SOPs and cGMPs.
• Perform in-process sampling, weight checks, component counting and basic math calculations.
• Perform in-process inspection and finished product visual inspection.
• Perform cleaning of rooms, tools, and equipment before and after use.
• Assist with other manufacturing areas as required.
• Perform activities right the first time in material handling/dispensing, compounding, and filling.
• Follow general instructions on routine work and detailed instructions on new projects or assignments.
• Follow all safety requirements and lead by example a safety-first culture.
• Work occasional hours outside of scheduled shift based on business needs, which may include weekend work.
• Other duties as assigned.

Conoscenze

SOPs

GDP

GMP

Troubleshooting

Documentation

Math calculations

Communication

Independent work

Teamwork

Formazione

High school diploma

Associate or Bachelor’s degree preferred

Strumenti

pH meters

Mixers

Stir plates

Isolators (aseptic)

Descrizione del lavoro

Alcami Corporation is seeking a Manufacturing Technician II – Sterile Injection to join our on-site team in Morrisville, NC. You will support aseptic filling, compounding, and fill/finish operations for sterile injectable products, working with isolator technologies and GMP compliance.

The role emphasizes SOP-driven tasks, accurate documentation, safety, and the ability to troubleshoot equipment. Night shift is 12 hours, 7:00 pm to 7:00 am, with occasional weekend requirements.