Production Technician I (weekend days)
Indianapolis
Thursday, 21 May 2026
Manufacture radioligand therapy products by following batch instructions and maintaining strict aseptic discipline. - Operate and maintain Grade A isolators to meet safety, quality, and key performance indicator targets. - Follow radiation safety requirements and comply with all state, federal, and Novartis guidelines. - Complete required training in Standard Operating Procedures, aseptic technique, gowning qualification, and Health, Safety, and Environment. - Clean production cells manually and sterilize isolators to ensure production readiness. - Perform routine and dynamic environmental monitoring per procedure and document results accurately. - Prepare materials, maintain identity and traceability, and update the batch monitoring system as required. - Execute work in alignment with current Good Manufacturing Practice and site quality standards. - Support qualification and validation activities; contribute to deviation investigations and inspection readiness. - Prepare and maintain batch records, shipping documentation, and training materials to ensure compliant operations. Essential Requirements: - Bachelor’s degree in relevant Engineering or Scientific discipline is highly preferred; If the applicant does not have a degree, a minimum of 1 year’ of experience in cGMP or aseptic environment is required. - Working knowledge of current Good Manufacturing Practice for sterile or aseptic manufacturing environments. - Ability to follow United States Food and Drug Administration guidance relevant to aseptic manufacturing. - Ability to gown aseptically and work extended periods in a Grade C cleanroom environment. - Strong attention to detail and ability to complete batch records and controlled documentation accurately. - Near vision equivalent to 20/20 with no color vision impairment; corrective lenses permitted. - Ability to lift or carry up to 35 pounds and perform hands-on production tasks. - Reliable teamwork and communication skills to succeed in a fast-paced, shift-based schedule. Desirable Requirements: - Radiopharmaceutical manufacturing experience preferred, especially in aseptic or cleanroom operations. - English proficiency for reading, writing, and speaking in a regulated manufacturing environment.