Joule is looking to add a manufacturing associate to their growing team in the Rockville, MD area. Please review the job description and qualifications below and send all updated resumes to Rhasan@jouleinc.comHelp for immediate consideration.
- Perform Aseptic filling operations and dynamic monitoring/sampling inside various isolators.
- Perform aseptic fill operations using isolator technology, visual inspection, labeling, and packaging in accordance with GMP regulations.
- Interact with cross-functional departments to troubleshoot, request materials, and overcome challenges in meeting production schedule.
- Wash and sterilize vials and filling components for use in production operations.
- Perform area clearance on equipment and rooms that involve cleaning, and integrity testing pre/post production.
- Adhere to Standard Operating Procedures (SOP), Good Documentation Practices (GDP), and current Good Manufacturing Practices (cGMP).
- Record Activities in production batch records, and equipment logbooks as well as updating and/or authoring SOPs.
- Assist in activities related to other onsite departments such as the execution of validation protocols.
- Occasional overtime and weekend work is required.
- Perform tasks under minimal supervision, and within tight time lines to meet production schedule.
- Report any unexpected observations and suggest possible explanation and resolution.
- B.S. Biology or Chemistry and 2 to 4 years of experience in a GMP facility
- In lieu of a B.S. degree, a HS Diploma with at least 5 years of experience in a GMP environment
- Previous experience with Aseptic technique, GMP, and GDP (Good Documentation Practices) is required
- Ability to lift 50 lbs