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Manufacturing Operations Specialist

2 months ago

Cranbury, New Jersey, United States Biocon Full time
Job Summary

As a key member of the Biocon team, the Manufacturing Operations Specialist will be responsible for the execution of all aspects of solid-dosage manufacturing. This includes, but is not limited to, the dispensing, granulation, sifting, milling, drying, encapsulation, coating, compression, and cleaning related activities.

Key Responsibilities
  • Manufacturing Operations: Assist Production Management with all scheduled and requested activities in an efficient and smooth operation.
  • Quality Assurance: Ensure all scheduled commercial and non-commercial manufacturing activities are completed on time.
  • Equipment Maintenance: Become proficient in the setup, operation, and cleaning of all cGMP equipment used during production operations.
  • Quality Investigations: Participate in all Quality Investigations as required.
  • Compliance: Adhere to all approved Standard Operating Procedures, Batch Records, and Safety Procedures as written when performing all daily activities.
  • Cleanliness and Safety: Ensure the cGMP area is cleaned and maintained following all SOP's and good housekeeping practices.
  • Personal Protective Equipment: Must use required PPE during cGMP activities as specified in the Batch Records and Safety Data Sheets.
Requirements
  • Regulatory Experience: Familiarity with working in a regulated pharmaceutical solid dosage facility.
  • Communication Skills: Ability to read and write documents written in English.
  • Teamwork: Excellent written communication skills.
  • Equipment Knowledge: Familiarity with various cGMP solid dosage Pharmaceutical manufacturing equipment. Able to setup, operate clean, and troubleshoot the solid dosage Pharmaceutical manufacturing equipment being used.
  • Independence: Able to work with minimal supervision.
  • Physical Demands: Able to stand on feet throughout an eight-hour work day.
  • Lifting: Able to lift up to 30 Ibs (14 Kgs) without assistance.
  • Personal Hygiene: Maintain personal hygiene habits consistent with working in a cGMP environment
  • Personal Protective Equipment: Be capable of wearing all required PPE; including partial and full facepieces based on OSHA guidelines.
Education and Experience
  • Education: High School Diploma or GED Equivalent.
  • Education (Optional): Bachelor's degree in Physical Sciences or Pharmaceutical life science related field of study.
  • Experience: 2-8 years related experience in cGMP production operation activities.
  • Work Permit: Must have Valid work permit.