Manufacturing Associate I, Support

This position operates on a 2-2-3 shift schedule: 7:00 AM–7:00 PM and 7:00 PM–7:00 AM.

About the role

The Manufacturing Support Associate I/II is responsible for executing production activities related to Media and Buffer preparation within a GMP environment. The role requires strict adherence to instructions provided in Solution Records (SRs), Standard Operating Procedures (SOPs), and associated forms. The ideal candidate will uphold Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP), ensuring "Right the First Time" (RFT) execution.

Responsibilities

• Dispense raw materials using analytical scales.
• Prepare media and buffers using equipment such as formation tanks, vessels, and SUMS (including single-use bags with mixers).
• Perform assembly preparation, parts washing, and autoclaving.
• Conduct clean-in-place (CIP) procedures for tanks and auxiliary equipment, including transfer pumps, crimpers, tubing welders, sealers, pH/conductivity meters, and filter integrity testers.
• Troubleshoot and continuously improve daily manufacturing operations in media/buffer formulation.
• Maintain ownership of production processes, manufacturing environment, and facility.

Requirements

• Deep understanding of manufacturing support operations fundamentals.
• Practical skills in media/buffer formulation using stainless steel tanks, vessels, SUMS, and single-use bags with mixers.
• Ability to follow GMP, GDP, and GLP standards.