Biotechnician II

Role Summary

Biotechnician II at BeOne Medicines. Work in a cleanroom environment following cGMP batch records and SOPs to manufacture drug products, supporting GMP Manufacturing projects and preparing suites for manufacturing operations. Responsible for executing drug product formulation, filling, visual inspection, labeling, and packaging, including materials requisition, setup, preparation, final filtration, formulation, filling vials inside a Grade A isolator with automated filling, labeling, inspection, packaging, and document review.

Responsibilities

• Support all site validation protocol execution and report generation
• Equipment start-up, troubleshoot, and perform acceptance testing
• Support the team by training other team members
• Execute on the floor operations during clinical and GMP campaigns
• Procedural design (SOPs, MBRs, etc.) and approval
• cGMP Manufacturing
  • Equipment cleaning and sterilization
  • Solution preparation and transfer
  • Room and Equipment Cleaning
  • Equipment and process troubleshooting
  • Sterile Filtration / Integrity testing
  • Good Documentation Practices
  • Environmental Monitoring
  • Autoclaves and washers (equipment prep, cleaning and sterilization)
  • Familiar with Vial washer, Tunnel, Filling, Inspection and Packaging
  • DP equipment set up
  • Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of hazards
  • Under the direction of the Production Supervisor, work hands on in ISO7/ISO8/ISO5 areas with various manufacturing equipment

Education/Experience

• Bachelor’s degree or 1+ years of GMP Manufacturing experience required
• Demonstrated ability to gown into aseptic manufacturing areas
• Excellent organization and time-management skills
• Ability to manage heavy workload, prioritize, and work under pressure
• Strong work ethic, positive attitude, problem solving, teamwork, self-confidence
• Ability to work in a fast-paced environment with strong time management and organization
• Strong organizational skills and ability to prioritize
• Dependable and punctual
• Proficient in Microsoft Office (Excel, Outlook, Word)
• Flexible to work 1st or 2nd shift with holidays, weekends and overtime as needed
• Customer/Client Focus

Skills / Competencies

• Strong PC literacy; MS Office (Outlook, Word, Excel, PowerPoint)

Education

• Not specified beyond above requirements

Additional Requirements

• Travel: International and domestic – periodically