Production Technician I (weekend days)
Novartis
12 hours ago
On-site
Indianapolis, IN
Operations
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 KPI targets.
- Follow radiation safety requirements and comply with state, federal, and company guidelines.
- Complete required training in SOPs, aseptic technique, gowning qualification, and Health/Safety/Environment.
- Clean production cells manually and sterilize isolators to ensure production readiness.
- Perform routine and dynamic environmental monitoring and document results.
- Prepare materials, maintain identity and traceability, and update the batch monitoring system.
- Execute work in alignment with cGMP and site quality standards.
- Support qualification/validation; contribute to deviation investigations and inspection readiness.
- Prepare and maintain batch records, shipping documentation, and training materials.
Qualifications (Essential):
- Bachelor’s degree in relevant Engineering/Scientific discipline (highly preferred) OR 1+ year cGMP or aseptic environment experience.
- Working knowledge of cGMP for sterile/aseptic manufacturing.
- Ability to follow FDA guidance relevant to aseptic manufacturing.
- Ability to gown aseptically and work extended periods in a Grade C cleanroom.
- Strong attention to detail; accurate completion of batch records/controlled documentation.
- Near vision 20/20 equivalent; no color vision impairment (corrective lenses permitted).
- Ability to lift/carry up to 35 lbs.
- Reliable teamwork and communication for a fast-paced, shift-based schedule.
Desirable:
- Radiopharmaceutical manufacturing experience (aseptic/cleanroom).
- English proficiency in a regulated environment.
Compensation/Benefits (if explicitly stated):
- Salary range: $25.19/hr to $46.83/hr; performance-based cash incentive; possible annual equity awards; US-based benefits and time off package.
Application instructions:
- Apply if accessible; relocation support not available.
- Manufacture radioligand therapy products by following batch instructions and maintaining strict aseptic discipline.
- Operate and maintain Grade A isolators to meet safety, quality, and KPI targets.
- Follow radiation safety requirements and comply with state, federal, and company guidelines.
- Complete required training in SOPs, aseptic technique, gowning qualification, and Health/Safety/Environment.
- Clean production cells manually and sterilize isolators to ensure production readiness.
- Perform routine and dynamic environmental monitoring and document results.
- Prepare materials, maintain identity and traceability, and update the batch monitoring system.
- Execute work in alignment with cGMP and site quality standards.
- Support qualification/validation; contribute to deviation investigations and inspection readiness.
- Prepare and maintain batch records, shipping documentation, and training materials.
Qualifications (Essential):
- Bachelor’s degree in relevant Engineering/Scientific discipline (highly preferred) OR 1+ year cGMP or aseptic environment experience.
- Working knowledge of cGMP for sterile/aseptic manufacturing.
- Ability to follow FDA guidance relevant to aseptic manufacturing.
- Ability to gown aseptically and work extended periods in a Grade C cleanroom.
- Strong attention to detail; accurate completion of batch records/controlled documentation.
- Near vision 20/20 equivalent; no color vision impairment (corrective lenses permitted).
- Ability to lift/carry up to 35 lbs.
- Reliable teamwork and communication for a fast-paced, shift-based schedule.
Desirable:
- Radiopharmaceutical manufacturing experience (aseptic/cleanroom).
- English proficiency in a regulated environment.
Compensation/Benefits (if explicitly stated):
- Salary range: $25.19/hr to $46.83/hr; performance-based cash incentive; possible annual equity awards; US-based benefits and time off package.
Application instructions:
- Apply if accessible; relocation support not available.