Role Summary
The Engineering Technician at our Concord, NC facility supports Parenteral Operations by ensuring the efficient setup and operation of Pre-Filled Syringe and Isolator Equipment. This role requires hands-on maintenance, troubleshooting, repairs, and ongoing upkeep of production equipment. The ideal candidate will deliver responsive, customer-focused support in a dynamic manufacturing environment.
Responsibilities
- Promote a safety-first, quality-always culture in all tasks and interactions
- Improve equipment uptime, line efficiency, and overall equipment effectiveness (OEE)
- Perform condition monitoring, troubleshooting, and provide operational support
- Diagnose and repair precision filling equipment with strong mechanical aptitude
- Collaborate with engineering and production teams to resolve equipment issues promptly
- Assist with equipment setup and changeovers to support production needs
- Adhere to all GMP and quality standards
- Diagnose root causes quickly and implement corrective actions to minimize downtime
- Accurately document maintenance activities and corrective actions
- Support cross-functional tasks and assist outside primary responsibilities as needed
- Work independently and manage priorities under pressure
Qualifications
- Required: High school diploma or GED
- Required: Minimum of 5 years’ experience in production maintenance
- Preferred: Associate’s degree or technical certification in a related field
- Preferred: Knowledge of FDA and GMP regulations
- Preferred: Experience operating high-speed, automated production equipment, preferably Syringe/Vial Filling systems utilizing Isolator technology
- Preferred: Familiarity with Computerized Maintenance Management Systems (CMMS) platforms
- Preferred: Strong verbal and written communication skills
- Preferred: Customer-oriented mindset with a proactive approach
Education
- High school diploma or GED
- Associate’s degree or technical certification in a related field (preferred)
Skills
- Strong mechanical aptitude and hands-on technical skills
- Proficient with basic hand tools
- Detail-oriented with a commitment to quality and precision
- Familiarity with safety protocols and proper PPE usage
- Physically able to stand for extended periods
- Effective team player with strong interpersonal skills
- Knowledge of FDA and GMP regulations
- Strong verbal and written communication skills
- Analytical thinker with strong problem-solving abilities
Additional Requirements
- Flexibility to work overtime or adjust schedule based on production demands
- Following a Monday–Friday, 8-hour training period, the role transitions to a 12-hour 2-2-3-day shift schedule
- Willing and able to respond to off-hour emergencies as needed
- Open to travel for training and professional development opportunities