Bioprocess Manufacturing Technician

Job Description

Job Description

The ideal candidate will have experience in cGMP cleanroom operations, raw material handling, solution preparation, and equipment preparation and a proven ability to operate within a highly automated environment to produce compliant, high-quality biopharmaceutical products .

Responsibilities:

• Follow standard operating procedures and batch records to execute production activities in compliance with cGMP requirements.
• Perform weighing and aliquoting of raw materials into intermediate bulk containers for stainless steel manufacturing operations.
• Kit materials and prepare small-scale solutions for single-use operations.
• Conduct environmental monitoring throughout the facility and document results accurately.
• Wash, autoclave, and prepare small equipment parts and assemblies for use in Upstream and Downstream processes.
• Support Upstream operations including media preparation and bioreactor setup and breakdown as needed.
• Support Downstream operations including buffer preparation, equipment cleaning and steaming in place, and formulation support as needed.
• Operate manufacturing and computerized systems safely and maintain accurate electronic and paper records.

Required Skills & Qualifications:

• Proficiency in English for reading, writing, and communication.
• Ability to work all assigned shifts, including 10-hour day or swing schedules, with required overtime, and stand for extended periods.
• Computer literacy to interface with manufacturing systems. Experience with distributed control systems or automation preferred.
• Ability to pass and maintain all cGMP-related training, tests, and annual re-qualifications.
• Physical capability to climb up to 6 flights of stairs daily and lift up to 25 lb.
• Ability to comply with cleanroom gowning requirements. No makeup, jewelry, or personal items permitted in clean areas.