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.
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.
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.
Numbers & Facts
Location
Rockville, MD
Skills
Asepsisunmatched
Biochemistryunmatched
Biologyunmatched
Biotech and Pharmaceuticalunmatched
Chemistryunmatched
Chromatographic Systemsunmatched
Cleaning Equipmentunmatched
Cleanroomunmatched
Corrective Actionunmatched
Current Good Manufacturing Practice (cGMP)unmatched
DeltaVunmatched
Drug Manufacturingunmatched
Laboratory Testingunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Equipmentunmatched
Manufacturing Operationsunmatched
Manufacturing/Industrial Processesunmatched
Operational Improvementunmatched
Process Improvementunmatched
Process Manufacturingunmatched
Product/Service Launchunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
SAPunmatched
Safety Processunmatched
Sample/Specimen Processingunmatched
Specimen Collectionunmatched
Standard Operating Procedures (SOP)unmatched
Technical Supportunmatched
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