Key Responsibilities
Manufacturing Operations
- Execute manufacturing processes for drug products per approved procedures
- Request and dispense raw materials for production
- Operate production equipment including reactors, filters, dryers, formulation, milling, and filling systems
- Collect in-process samples for laboratory testing
- Clean and maintain equipment and production areas in accordance with cGMP standards
- Follow safety procedures and maintain a clean, hazard-free work environment
- Handle and manage production waste in compliance with safety and environmental regulations
Documentation & Compliance
- Complete and review batch records in accordance with Good Documentation Practices (GDP)
- Maintain accurate and timely logbook entries
- Follow Standard Operating Procedures (SOPs) precisely
- Revise GMP documents as required
- Support deviation investigations and other GMP documentation activities
Maintenance & Instrumentation Support
- Assist in preventative maintenance of equipment and instrumentation
- Support upkeep of equipment logs and calibration records
- Suggest and implement improvements to equipment or processes
- Monitor and record environmental conditions as required
- Maintain adequate inventory of production consumables and supplies
Qualifications
Education
- High school diploma, GED, or equivalent required
- Bachelor’s degree in a scientific or technical field preferred
- Strong mechanical aptitude and problem-solving ability
- Excellent attention to detail and accuracy in documentation
- Proficient in basic mathematics and computer applications (MS Office Suite)
- Ability to follow complex written and verbal technical instructions
- Strong communication skills, both written and verbal
- Demonstrated ability to work in a team-based environment
Experience
- 2–4 years of experience in a GMP-regulated manufacturing environment or equivalent
- Hands-on experience with operating, cleaning, and maintaining pharmaceutical production equipment
- Experience with SOPs, deviations, and validation protocols preferred
- Previous experience training other technicians is a plus
Seniority level
Employment type
Job function
- Science
- Staffing and Recruiting