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
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