Manufacturing Associate

Position Summary

Sustain GMP readiness of cleanrooms by executing routine and ad-hoc facility sanitization, performing viable and non-viable environmental monitoring, supporting material/equipment/product flow throughout the facility, and providing production support. The role is highly detail-oriented, documentation-driven, and integral to contamination control and patient safety.

Key Responsibilities

• Perform routine scheduled and ad hoc cleaning and environmental monitoring of classified cleanrooms in accordance with SOPs, cGMP requirements, and regulatory expectations
• Accurately complete cleaning and environmental monitoring logs and documentation to ensure GDP compliance
• Support inspection readiness by maintaining cleanroom standards and addressing deviations promptly
• Safely transfer raw materials, consumables, drug product, waste, and equipment throughout the facility including classified locations
• Support material staging and preparation to enable timely manufacturing operations
• Assist production staff with ancillary support tasks as needed, such as cryopreservation transfer tasks and equipment setup.
• Adhere strictly to GMP, GDP, and safety requirements during all activities
• Maintain training status including aseptic gowning qualification and requalification
• Identify and escalate any deviations or anomalies observed during cleaning, EM, or material handling
• Support deviation investigations
• Lead training activities for cleaning and environmental monitoring

Required Qualifications

• Bachelor’s degree in a science-based discipline (e.g., biology, chemistry, biotechnology) or, associate’s degree with 1–3 years of experience in a GMP-regulated work
• Familiarity with environmental monitoring methods and good documentation standards
• Strong attention to detail with proven ability to follow SOPs and GDP requirements
• Strong teamwork and communication skills with flexibility to support cross-functional needs