The Production Technician will execute day-to-day manufacturing activities in the sterile injectable IV bag production area, ensuring adherence to cGMP requirements, safety standards, and company procedures. In addition to performing typical operator duties such as setup, operation, and cleaning of manufacturing equipment, the Production Technician will have elevated responsibilities including performing routine maintenance, supporting and participating in equipment and process qualifications, and serving as the first line of troubleshooting for production equipment issues. This role requires strong technical skills, a commitment to quality, and the ability to work in a highly regulated, sterile manufacturing environment involving isolator technology, high potent APIs, and controlled substances.
Key Responsibilities:
- Operate, monitor, and adjust sterile manufacturing equipment for formulation, filling, and packaging of IV bag products in compliance with cGMP and SOPs.
- Perform routine preventive maintenance tasks on production equipment, ensuring operational readiness and minimizing downtime.
- Support equipment and process qualifications, including execution assistance, documentation support, and ensuring adherence to qualification protocols.
- Serve as first-line troubleshooting support for mechanical or operational equipment issues, escalating to Engineering or Maintenance as needed.
- Assist with isolator technology operations, including cleaning, sterilization, and environmental control procedures.
- Participate in line clearance, changeover, and cleaning activities to maintain production operations.
- Accurately complete batch records, logbooks, and production documentation in compliance with data integrity requirements and cGMP practices.
- 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.
- Contribute to continuous improvement initiatives to enhance safety, efficiency, and product quality.
- Work closely with cross-functional teams including Engineering, Validation, and Quality to support operational readiness.
- Comply with all Environmental Health & Safety (EHS) standards and maintain a clean and safe work environment.
Qualifications / Experience:
- High school diploma or equivalent required; associate degree or technical certification in a mechanical, engineering, or life sciences discipline preferred.
- Minimum of 2 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.
- Strong mechanical aptitude with the ability to perform routine maintenance and troubleshoot equipment issues.
- Experience working with automated production equipment utilizing HMI or SCADA interface required.
- Familiarity with cGMP, aseptic processing, and controlled substance regulations highly preferred.
- Ability to read and follow technical documents such as SOPs, maintenance procedures, and qualification protocols.
Skills / Competencies:
- Strong technical and mechanical problem-solving skills.
- Attention to detail and commitment to quality and data integrity.
- Ability to work in a fast-paced, highly regulated environment.
- Effective communication skills, both verbal and written.
- Team-oriented mindset with willingness to collaborate across functions.
- Comfortable working in cleanroom environments with PPE requirements.