Manufacturing Associate

Key Responsibilities:

• Perform all activities associated with the manufacturing process, including setup, operation, and maintenance of production equipment and isolators.
• Ensure compliance with safety, environmental, and quality regulations while maintaining focus on key performance goals.
• Complete required training programs covering Standard Operating Procedures (SOPs), aseptic techniques, gowning, and health and safety practices.
• Support production readiness by cleaning and sterilizing work areas and equipment.
• Conduct environmental monitoring and ensure documentation accuracy throughout all production stages.
• Prepare and track all materials in alignment with established procedures and batch record systems.
• Maintain compliance with cGMP requirements and support investigations, audits, and validation activities as needed.
• Accurately complete and review all production records, logs, and related documentation.

Qualifications:

• Bachelor’s degree in a scientific or engineering discipline preferred.
• In lieu of a degree, at least 1 year of experience in a cGMP-regulated or aseptic manufacturing environment is required.
• Familiarity with FDA or other regulatory guidelines relevant to sterile production.
• Ability to work aseptically in a cleanroom (Grade C or equivalent) for extended periods.
• Must meet visual acuity standards (corrective lenses acceptable).
• Capability to lift or carry up to 35 pounds.
• Prior experience in pharmaceutical or radiopharmaceutical manufacturing is advantageous.