Bioprocess Manufacturing Technician
Xtalks · Rockville, MD · 2 wk ago
ManagementFull-time
About the role
The Bioprocess Manufacturing Technician supports upstream and downstream biopharmaceutical manufacturing operations in a cGMP-regulated environment.
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.