Job Details
Production Technician
Job Purpose
The Production Technician II is responsible for the safe manufacture of active pharmaceutical ingredients (APIs) and drug products in a Good Manufacturing Process (GMP) environment. This position will operate, clean, and maintain manufacturing equipment, instrumentation, and facilities necessary to support GMP production processes in API manufacturing.
Essential Duties & Responsibilities
Operations Execution
Execute API/Drug Product manufacturing operations in the Company's current Good Manufacturing Process facility:
- Request and dispense raw materials for manufacture
- Operate process reactors, filters, dryers, fillers, milling, and formulation equipment
- Sample product as directed for testing
- Clean and maintain production equipment and areas
- Maintain a safe working environment
- Observe and follow all safe operation practices
- Waste management
Documentation
Complete and maintain documentation in accordance with expected Good Documentation Practices (GDP):
- Follow and complete batch records
- Fill out and review logbooks
- Follow standard operating procedures (SOPs)
- Ability to revise GMP documents required
- Assist in deviation investigations and all other forms of GMP documentation
Maintenance and Instrumentation Support
Maintain equipment and instrumentation necessary to support cGMP manufacture of APIs as described in production batch records:
- Participate in preventative maintenance activities
- Assist in maintaining equipment records
- Suggest and implement improvements to operations
- Monitor environmental parameters
- Maintain inventory of consumables and supplies
Education
HS degree, GED, or equivalent experience
Bachelor s degree preferred
Knowledge and Skills
Strong mechanical aptitude and critical thinking
Proficient with computers and basic math
Attention to detail and documentation
Ability to follow written and verbal technical instruction
Strong verbal and written communication skills
Proficiency in MS office required
Experience
Experience with cleaning, maintaining, and controlling equipment
2-4 years experience in a GMP manufacturing environment or equivalent
Experience with cleaning, maintain, and controlling qualified equipment
SOP writing experience preferred
Ability to write deviations and validation protocols preferred
Experience training others preferred