Process Development Technician - II - USD

The Fountain Group is currently seeking a -------- Process Development Technician II for a prominent client of ours. This position is located in -
- Frederick, MD. Details for the position are as follows:

Job Title: Process Development Technician II
Location: Andover, MA
Pay Rate: $29/hour
Duration: 11.5 Months

The Process Development Technician II supports commercial, clinical, and development manufacturing by executing GMP production operations in accordance with Standard Operating Procedures (SOPs) and production schedules. This role is responsible for operating bioprocess equipment, supporting process improvements, troubleshooting manufacturing issues, and ensuring compliance with GMP documentation and validation requirements.

Responsibilities:

• Execute manufacturing operations involving buffer/media preparation, bioreactors, filtration systems, chromatography skids, UF/DF skids, autoclaves, and glass washers.

• Perform unit operations including CIP, SIP, sanitization, and other GMP manufacturing processes.

• Support equipment commissioning, qualification, validation, and issue resolution.

• Troubleshoot manufacturing equipment, automation systems, and process-related issues.

• Complete GMP documentation, batch records, and production data entry while monitoring process compliance.

• Support audit readiness activities, GMP walkthroughs, and compliance improvements.

• Assist with QTS investigations and CAPA implementation activities.

• Support Lean Manufacturing, Operational Excellence, and continuous improvement initiatives.

• Generate maintenance work requests for manufacturing equipment as required.

• Maintain inventory reconciliation and manufacturing metrics using enterprise systems.

• Associate's or Bachelor's degree in Biotechnology, Biology, Biochemistry, Chemical Engineering, Life Sciences, or a related technical discipline.

• Equivalent biopharmaceutical manufacturing experience may be considered.

• GMP biopharmaceutical manufacturing

• Buffer and media preparation

• Bioreactor operations

• Chromatography systems

• Ultrafiltration/Diafiltration (UF/DF)

• Filtration equipment operation

• Glass washer and autoclave operation

• CIP/SIP and sanitization processes

• Equipment commissioning, qualification, and validation

• Manufacturing process troubleshooting

• Batch record documentation

• SAP /LIMS /AMPS /PDOCS /QTS

• CAPA support

• Lean Manufacturing

• Operational Excellence

• Inventory reconciliation

• Commercial biologics manufacturing

• Clinical manufacturing operations

• Automated bioprocess equipment

• GMP audit support

• Manufacturing campaign support

• Continuous process improvement initiatives

• Process validation support

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