Job Description

Role: GMP Cleanroom Operator

Location: Western New York

Position Overview

We are seeking an experienced GMP Cleanroom Operator to support pharmaceutical manufacturing operations in a regulated cleanroom environment. The ideal candidate will have a strong production background within GMP facilities and hands-on experience supporting PQ activities and GMP clinical batch manufacturing. This role requires strict adherence to gowning protocols, procedures, and GMP documentation practices.

Key Responsibilities

• Perform production operations within a GMP-regulated cleanroom environment
• Support Process Qualification (PQ) and GMP clinical batch manufacturing activities
• Follow and maintain strict cleanroom gowning procedures and aseptic techniques
• Accurately complete, review, and maintain GMP documentation and batch records
• Review, understand, and sign IP (In-Process) assignments as required
• Comply with all site SOPs, safety requirements, and regulatory guidelines
• Maintain a high level of attention to detail to ensure product quality and compliance

Required Skills & Qualifications

• 3–5 years of experience working in a GMP manufacturing environment
• Strong background in production operations within cleanroom settings
• Proven knowledge of gowning techniques and cleanroom behavior
• Experience supporting PQ and GMP clinical batches
• Solid understanding of GMP documentation practices
• Ability to follow procedures precisely and work in a highly regulated environment

Preferred Qualifications

• Prior experience in pharmaceutical or biotech manufacturing
• Familiarity with clinical-stage manufacturing operations

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