Harba Solutions Inc.

Compensation

Full Description

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.