This role involves hands-on work with production equipment and materials to support manufacturing operations, including weigh/dispense, solution preparation, equipment cleaning (CIP/COP), small parts cleaning, and materials handling. The position requires close collaboration with internal support teams such as Facilities, QC, QA, Materials Management, and EHS to maintain compliance and operational excellence.

Key Responsibilities

• Operate production equipment in accordance with SOPs to produce clinical products safely and compliantly.
• Execute manufacturing tasks including weighing, dispensing, solution preparation, and equipment cleaning (CIP/COP).
• Support materials handling and inventory management within manufacturing suites.
• Maintain accurate and detailed batch records and documentation in compliance with cGMP.
• Collaborate with cross-functional support groups (Facilities, QC, QA, EHS) to ensure smooth operations.
• Identify and communicate potential issues, assisting in troubleshooting and process improvements.
• Participate in equipment setup, calibration, and shutdown activities as needed.
• Ensure adherence to safety procedures and quality standards at all times.

Requirements

• Bachelor’s degree in Biotechnology or a related scientific field (required).

• Strong understanding of cGMP manufacturing processes and compliance principles.
• Ability to follow complex procedures and retain technical information effectively.
• Proven troubleshooting skills with the ability to identify and resolve issues quickly.
• Excellent communication and teamwork skills; comfortable collaborating in a fast-paced environment.

Preferred Experience

• Hands-on experience with Tangential Flow Filtration (TFF) or Ultrafiltration/Diafiltration (UFF) operations.
• Familiarity with HPLC systems.
• Exposure to automation systems such as DeltaV or similar.
• Basic understanding of automated manufacturing systems and process controls.

Benefits

• Shift: 4x10 Weds-Sat 6am-4pm
• 1 year contract