Production Technician

7 days ago

Durham, North Carolina, United States Advanced Recruiting Partners Full time
Production Technician Job PurposeThe 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
Other
  • Perform other duties as assigned
  • Ability to wear a powered air purifying respirator required
Education, Skills, and Experience 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
#IND

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