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

Manufacturing Technician II – Sterile Injection – 12‑Hour Night Shift (2‑2‑3)

Location: Morrisville, NC.

The Manufacturing Technician II (Compound/Fill/Finish) is accountable for results in a fast‑paced environment and assists with the manufacturing of sterile injectable products in vial and syringe configurations for clinical/commercial distribution. The Manufacturing Tech II is a key role responsible for executing advanced production tasks involving compound, fill and finish processes for sterile injectable pharmaceutical products executed via aseptic isolator technology. This position entails a high level of technical expertise in aseptic processes requiring single‑use components, ability to troubleshoot, and responsibility for maintaining quality and compliance with Good Manufacturing Practices (GMP).

The Manufacturing Tech II performs the operation of manufacturing processing equipment by following standard operating procedures (SOPs) and batch records in accordance with regulatory agencies and current Good Manufacturing Practices (cGMPs). The Manufacturing Tech II employs acceptable techniques while working in manufacturing environments, including PPE gowning. The candidate must have the ability to learn specific department procedures, have a general understanding of Good Documentation Practices (GDP) and GMP, and follow directions from leadership/peers to ensure manufacturing goals are met.

• 100% on‑site position.
• Night Shift: 12‑hour rotating (2‑2‑3), 7:00 pm – 7:00 am.

• 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 escalates 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.

• Equipment and component preparation and sterilization (filter integrity testing, autoclaving, parts wrapping)
• Compounding
• Vial washing / depyrogenation
• Aseptic filling / stoppering / capping
• Lyophilization
• Visual inspection
• Facility cleaning/sanitation
• Documentation review (batch record, logbooks, etc.)

• High school diploma or GED required; associate or bachelor's degree preferred.
• 1–2 years work experience required; 2–5 years preferred.
• Prior work experience in a cGMP…