Production Technician

The Fountain Group is currently seeking a Production Technician/Associate Specialist for a prominent client of ours. This position is located in Rockville, MD . Details for the position are as follows:

Job Title: Associate Specialist - Cell Therapy Manufacturing
Location: Rockville, MD
Pay Rate: $29/hr
Duration: 12 Months

Job Description

• Support cGMP clinical manufacturing operations for cell therapy products in a Grade A/B cleanroom environment.
• Execute manufacturing batch records, work instructions, SOPs, and bill of materials while ensuring accurate GMP documentation.
• Perform batch record reconciliation and support deviation, non-conformance, and OOS investigations.
• Operate, monitor, clean, and maintain automated cell processing, cell expansion, and filling equipment.
• Perform aseptic manufacturing activities using open and closed processing systems.
• Review batch records, SOPs, and logbooks for accuracy, completeness, and GMP compliance.
• Support technology transfer and process development activities through execution of manufacturing studies and process improvements.
• Assist with equipment troubleshooting, process optimization, and manufacturing floor support.
• Maintain manufacturing documentation in accordance with cGMP requirements.
• Follow cleanroom gowning procedures and strict contamination control practices.

Education

• Bachelor's or Master's degree in Life Sciences, Biotechnology, Biology, Biochemistry, Biomedical Engineering, Chemical Engineering, or a related scientific discipline.
• Bachelor's degree with 0-3 years of cGMP manufacturing experience, or Master's degree with 0-2 years of cGMP manufacturing experience.

Required Skills

• cGMP manufacturing in biologics, cell therapy, gene therapy, viral vector, or biopharmaceutical environments.
• Hands-on aseptic processing and cleanroom manufacturing (Grade A/B or ISO-classified environments).
• Experience with cell culture and/or biologics manufacturing processes.
• Operation of automated cell processing, cell expansion, filling, or related bioprocess equipment.
• Batch record execution, GMP documentation, SOP compliance, and bill of materials management.
• Experience supporting deviations, non-conformances, OOS investigations, and batch record reconciliation.
• Knowledge of open and closed manufacturing systems.
• Proficiency with Microsoft Excel, Word, and manufacturing documentation systems.

Preferred Skills

• Cell therapy, CAR-T, gene therapy, or viral vector manufacturing experience.
• Process development or technology transfer experience.
• Experience with automated bioprocessing equipment and process analytical technologies (PAT).
• Knowledge of manufacturing process optimization and equipment troubleshooting.
• Experience authoring or revising batch records, SOPs, and manufacturing documentation.

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