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.

Key Responsibilities

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

Qualifications / Experience

• 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

Skills / Competencies

• 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.