Production Technician

The Production Technician II is an advanced-level technician role responsible for sterile pharmaceutical manufacturing operations, with additional expectations for technical troubleshooting, routine maintenance, and active support of qualification activities. This position operates in an isolator-based manufacturing environment, works with high potent APIs and controlled substances, and plays a key role in ensuring compliance with cGMP, safety, and site procedures. The Production Technician II serves as a technical resource within the production team and supports continuous improvement of manufacturing processes.

• Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with SOPs, cGMP, and safety requirements.
• Perform routine preventive maintenance and minor repairs on production equipment to maintain optimal operating conditions.
• Serve as first-line troubleshooting support for equipment and process issues, escalating to engineering or maintenance as required.
• Support equipment and process qualifications, including protocol review, execution participation, and documentation completion.
• Assist in the creation, revision, and implementation of SOPs and production-related procedures.
• Provide training, guidance, and on-the-job support to Production Technician I personnel.
• Perform cleaning, changeover, and line clearance activities to maintain manufacturing operations.
• Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.
• Review documentation completed by fellow members of the production team.
• Collaborate with Quality Assurance during in-process checks, deviation investigations, and CAPA activities.
• Adhere to DEA and site procedures for controlled substance handling, including documentation and security protocols.
• Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.
• Operate isolator technology, including performing and verifying sanitization steps, and supporting advanced troubleshooting.
• Ensure controlled substances are handled, documented, and stored per DEA and site requirements.
• Participate in continuous improvement and lean manufacturing initiatives to enhance safety, quality, and efficiency.

• High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.
• Minimum of 5 years’ experience in pharmaceutical or regulated manufacturing in areas of compounding, filling, inspection, and secondary packaging. Experience with sterile products or IV bag production preferred.
• Demonstrated mechanical aptitude with hands-on equipment troubleshooting and maintenance skills.
• Knowledge of cGMP, aseptic processing, and controlled substance handling requirements.
• Minimum of 3 years’ experience working with automated production equipment utilizing HMI or SCADA interface required.
• Experience with isolator-based manufacturing strongly preferred.
• Experience reading and following technical documents such as SOPs, maintenance procedures, electrical drawings, equipment arrangements, piping diagrams, and qualification protocols.
• Demonstrated problem-solving and mechanical troubleshooting skills.
• Ability to mentor and train less experienced technicians.
• Excellent attention to detail and documentation accuracy.
• Effective communication and teamwork skills.
• Commitment to safety, quality, and data integrity.
• At home working in cleanroom environments with PPE requirements.