Bioprocess Manufacturing Technician

Bioprocess Manufacturing Technician

The Bioprocess Manufacturing Technician supports upstream and downstream biopharmaceutical manufacturing operations in a cGMP-regulated environment. This position is responsible for operating manufacturing equipment, preparing process materials, executing batch records, monitoring critical process parameters, and ensuring compliance with quality and regulatory requirements throughout the manufacturing process.

Roles & Responsibilities:

• Execute upstream and downstream manufacturing processes according to approved batch records.
• Prepare buffers, media, and process solutions for manufacturing operations.
• Operate bioreactors, filtration systems, chromatography equipment, and support process equipment.
• Monitor and record critical process parameters throughout production.
• Perform equipment setup, cleaning, sanitization, and changeover activities.
• Collect process samples and support laboratory testing activities.
• Complete electronic and paper batch documentation accurately and on time.
• Follow aseptic techniques and cleanroom gowning procedures.
• Support deviation investigations and implement corrective actions as required.
• Ensure compliance with cGMP, SOPs, safety procedures, and regulatory guidelines.
• Participate in process improvement and operational excellence initiatives.
• Support technology transfer and new product introduction projects when required.

Requirements:

• 2–5 years of biotechnology or pharmaceutical manufacturing experience.
• Experience working in cGMP-regulated manufacturing facilities.
• Hands-on experience with upstream or downstream bioprocess equipment preferred.
• Familiarity with batch records, SAP, MES, or DeltaV systems is a plus.
• Knowledge of aseptic processing and cleanroom operations preferred.
• Associate or Bachelor's Degree in Biotechnology, Biology, Chemistry, Biochemistry, or related Life Science field preferred.
• Equivalent manufacturing experience may be considered.