Production Technician I (Weekday PM)
Novartis
12 hours ago
On-site
Indianapolis, IN
Operations
Key Responsibilities:
- 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 state, federal, and company 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/validation; contribute to deviation investigations and inspection readiness.
- Prepare and maintain batch records, shipping documentation, and training materials for compliant operations.
Essential Requirements:
- Bachelor’s degree in relevant Engineering or Scientific discipline (highly preferred) or 1+ year experience in cGMP or aseptic environment.
- Working knowledge of current cGMP for sterile/aseptic manufacturing.
- Ability to follow US FDA guidance for aseptic manufacturing.
- Ability to gown aseptically and work extended periods in a Grade C cleanroom.
- Strong attention to detail; accurate completion of batch records and controlled documentation.
- Near vision ~20/20; no color vision impairment (corrective lenses permitted).
- Ability to lift/carry up to 35 pounds and perform hands-on production tasks.
- Reliable teamwork and communication for a fast-paced, shift-based schedule.
Desirable Requirements:
- Radiopharmaceutical manufacturing experience, especially aseptic/cleanroom operations.
- English proficiency in a regulated manufacturing environment.
Compensation/Benefits:
- Salary expected: $25.19/hr to $46.83/hr.
- Performance-based cash incentive; potential annual equity awards (role-dependent).
- US-based eligible employees: health, life, disability, 401(k) with company contribution and match, other benefits; time off (vacation, personal days, holidays, other leaves).
- 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 state, federal, and company 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/validation; contribute to deviation investigations and inspection readiness.
- Prepare and maintain batch records, shipping documentation, and training materials for compliant operations.
Essential Requirements:
- Bachelor’s degree in relevant Engineering or Scientific discipline (highly preferred) or 1+ year experience in cGMP or aseptic environment.
- Working knowledge of current cGMP for sterile/aseptic manufacturing.
- Ability to follow US FDA guidance for aseptic manufacturing.
- Ability to gown aseptically and work extended periods in a Grade C cleanroom.
- Strong attention to detail; accurate completion of batch records and controlled documentation.
- Near vision ~20/20; no color vision impairment (corrective lenses permitted).
- Ability to lift/carry up to 35 pounds and perform hands-on production tasks.
- Reliable teamwork and communication for a fast-paced, shift-based schedule.
Desirable Requirements:
- Radiopharmaceutical manufacturing experience, especially aseptic/cleanroom operations.
- English proficiency in a regulated manufacturing environment.
Compensation/Benefits:
- Salary expected: $25.19/hr to $46.83/hr.
- Performance-based cash incentive; potential annual equity awards (role-dependent).
- US-based eligible employees: health, life, disability, 401(k) with company contribution and match, other benefits; time off (vacation, personal days, holidays, other leaves).