Clean Room Operator

Clean Room Operator

The Clean Room Operator produces finished packaged and labeled clinical products, including kits, in accordance with batch instructions and current Good Manufacturing Practice (cGMP) standards. This role focuses on accurate, compliant production of medical or life sciences products, with meticulous documentation of all activities following good documentation practices and established specifications.

• Produce finished packaged and/or labeled clinical products, including kits, strictly following batch instructions and cGMP requirements.
• Follow all current Good Manufacturing Practices to ensure product quality, safety, and regulatory compliance.
• Complete all required production and packaging documentation accurately and legibly, adhering to good documentation practices (GDP).
• Perform manual data recording and data entry into systems such as spreadsheets and ERP tools with a high level of attention to detail.
• Inspect products and components during and after packaging to verify they meet established specifications and quality standards.
• Work effectively and cooperatively with other operators in a clean room environment to meet production goals.
• Handle small batches and clinical packaging tasks in both standard and cold room environments as required.
• Use tablets and other technology tools comfortably for data entry, smart sheets, and ERP-related tasks.
• Maintain good manual dexterity for handling small components, performing inspections, and executing detailed packaging tasks.
• Follow gowning procedures and clean room protocols, including wearing shoe covers, hair nets, beard nets, and covering piercings.
• Adhere to facility rules such as no nail polish and proper use of provided jackets or personal jackets in cold rooms.
• Support a collaborative, team-oriented culture by communicating clearly, sharing information, and participating in group activities.
• Perform simple mathematical calculations when required for batch counts, labeling, or packaging activities.
• Participate in overtime work on a voluntary basis when requested, typically in the early morning, to support production needs.

• At least 6 months of experience in a medical device or life sciences manufacturing environment.
• Basic knowledge of Good Documentation Practices (GDP) and experience applying them in a production setting.
• Knowledge and understanding of current Good Manufacturing Practice (cGMP).
• Experience with manual data processes and the ability to maintain clear, legible handwriting for documentation.
• Comfort with technology, including tablets, smart sheets, ERP systems, and data entry into Excel.
• Good manual dexterity for handling components, performing inspections, and working efficiently in a clean room.
• Ability to effectively work with other operators and collaborate in a team-based environment.
• Basic communication skills to follow instructions, ask questions, and document work clearly.
• Basic mathematical skills to perform simple calculations when required.
• Comfort working in clean rooms and following strict gowning and cleanliness protocols.
• Ability to work in cold rooms for short periods (up to approximately 15 minutes at a time) while performing small batch tasks.

• Previous pharmaceutical clinical packaging and/or labeling experience is desirable.
• Knowledge in pharmaceutical, medical device, or related life sciences manufacturing is advantageous.
• Experience with inspection activities in a clean room or regulated environment is beneficial.
• Strong hand-eye coordination and attention to detail when working with small components and labels.
• Ability to adapt to different departments and tasks as opportunities arise for skill development.
• Willingness to participate in…