Production Technician I (weekdays)
Novartis
11 hours ago
On-site
Indianapolis, IN
Operations
Shift: Monday–Thursday 6am–6pm and then Monday–Wednesday 6am–6pm; mandatory overtime may be required.
Key Responsibilities:
- Manufacture radioligand therapy products by following batch instructions and maintaining strict aseptic discipline.
- Operate and maintain Grade A isolators; meet safety, quality, and KPI targets.
- Follow radiation safety requirements and comply with applicable state/federal/guidelines.
- Complete training in SOPs, aseptic technique, gowning qualification, and Health/Safety/Environment.
- Clean production cells and sterilize isolators; perform routine and dynamic environmental monitoring and document results.
- Prepare materials; maintain identity/traceability; update batch monitoring system.
- Work in alignment with current cGMP and site quality standards.
- Support qualification/validation, deviation investigations, and inspection readiness.
- Prepare/maintain batch records, shipping documentation, and training materials.
Essential Requirements:
- Bachelor’s degree in relevant Engineering/Scientific discipline (highly preferred); otherwise 1+ year experience in cGMP or aseptic environment.
- Working knowledge of cGMP for sterile/aseptic manufacturing.
- Ability to follow FDA guidance for aseptic manufacturing.
- Ability to gown aseptically and work extended periods in a Grade C cleanroom.
- Strong documentation accuracy; attention to detail.
- Near vision ~20/20; no color vision impairment (corrective lenses permitted).
- Ability to lift/carry up to 35 lbs.
- Reliable teamwork and communication.
Desirable Requirements:
- Radiopharmaceutical manufacturing experience (aseptic/cleanroom preferred).
- English proficiency.
Compensation & Benefits (as stated):
- Salary range: $25.19/hr–$46.83/hr; includes performance-based cash incentive and may be eligible for annual equity awards. US-based eligible employees receive comprehensive benefits and time off.
Key Responsibilities:
- Manufacture radioligand therapy products by following batch instructions and maintaining strict aseptic discipline.
- Operate and maintain Grade A isolators; meet safety, quality, and KPI targets.
- Follow radiation safety requirements and comply with applicable state/federal/guidelines.
- Complete training in SOPs, aseptic technique, gowning qualification, and Health/Safety/Environment.
- Clean production cells and sterilize isolators; perform routine and dynamic environmental monitoring and document results.
- Prepare materials; maintain identity/traceability; update batch monitoring system.
- Work in alignment with current cGMP and site quality standards.
- Support qualification/validation, deviation investigations, and inspection readiness.
- Prepare/maintain batch records, shipping documentation, and training materials.
Essential Requirements:
- Bachelor’s degree in relevant Engineering/Scientific discipline (highly preferred); otherwise 1+ year experience in cGMP or aseptic environment.
- Working knowledge of cGMP for sterile/aseptic manufacturing.
- Ability to follow FDA guidance for aseptic manufacturing.
- Ability to gown aseptically and work extended periods in a Grade C cleanroom.
- Strong documentation accuracy; attention to detail.
- Near vision ~20/20; no color vision impairment (corrective lenses permitted).
- Ability to lift/carry up to 35 lbs.
- Reliable teamwork and communication.
Desirable Requirements:
- Radiopharmaceutical manufacturing experience (aseptic/cleanroom preferred).
- English proficiency.
Compensation & Benefits (as stated):
- Salary range: $25.19/hr–$46.83/hr; includes performance-based cash incentive and may be eligible for annual equity awards. US-based eligible employees receive comprehensive benefits and time off.