Production Technician, Am Shift

Novartis

2+ years

Not Disclosed

Indianapolis

10 July 31, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Summary

Internal Role Title: Production Technician
Location: Indianapolis, IN #LI-Onsite
Note: Novartis is unable to offer relocation support for this role; please apply only if you are already based in or can access this location.

About the Role:
At Advanced Accelerator Applications, a Novartis company, we are pioneering innovations in nuclear medicine to deliver cutting-edge radioligand therapies for cancer patients. We are seeking experienced Quality Control professionals to join our team. Production Technicians will be actively involved in the daily production of Radioligand Therapies (RLT) and the setup and preparation of instruments and equipment, adhering to regulatory requirements and batch records.

Key Responsibilities

Manufacturing Operations: Execute all activities related to the production of RLT products, including operating and maintaining Grade A isolators and adhering to KPI goals while following radiation safety guidelines.
Training: Complete required training curriculum, including Standard Operating Procedures (SOPs), Aseptic Techniques, and Health and Safety Environment (HSE) training.
Technical Support: Handle technical aspects of production readiness, including manual cleaning and sterilization of isolators. Conduct routine and dynamic environmental monitoring.
Material Preparation: Prepare materials while maintaining their identity according to the batch monitoring system.
Compliance: Ensure adherence to current Good Manufacturing Practices (cGMP) and participate in qualification/validation activities, deviation investigations, and inspections as needed.
Documentation: Prepare and maintain documents such as batch records, shipping documents, and training materials.
Shift Schedule: This role involves a rotating 12-hour shift schedule, Thursday-Sunday or Friday-Sunday, 6am-6pm. Mandatory overtime may be required.

Essential Requirements

Education: Bachelor’s degree in a relevant Engineering or Scientific discipline is highly preferred. Alternatively, a minimum of 1+ years of experience in a cGMP or aseptic environment is required.
Experience: Knowledge of cGMP regulations and FDA guidance applicable to aseptic manufacturing is highly preferred. Radio Pharma experience is advantageous.
Skills: Ability to gown aseptically and work in a clean room environment (Grade C) for extended periods. Near vision performance equivalent to 20/20 with or without corrective lenses is required. Ability to lift or carry up to 35 pounds.
Visual Acuity: Near vision equivalent to 20/20, with or without corrective lenses.

Compensation and Benefits

Pay Range: $27.40 to $41.15 per hour. Final pay is based on factors such as location, experience, skills, and market conditions. Total compensation may include a sign-on bonus, restricted stock units, discretionary awards, and a comprehensive benefits package.
Benefits: For more details on benefits and rewards, refer to the Novartis Life Handbook.

Why Novartis?

Novartis is committed to reimagining medicine to improve and extend lives. Our success is driven by a community of dedicated and passionate individuals who collaborate and inspire each other to achieve breakthroughs. Join us to be part of this mission and learn more about our values and culture here.

Join Our Network: If this role isn't a perfect fit, join our Novartis Network to stay updated on future opportunities.

EEO Statement: Novartis is an Equal Opportunity Employer. We do not discriminate in recruitment, hiring, or other employment practices based on race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams and creating an inclusive workplace.

Accessibility & Reasonable Accommodations: If you require reasonable accommodation due to a medical condition or disability, please contact us at us.reasonableaccommodations@novartis.com or call +1(877)395-2339. Include the job requisition number in your message.

Division: Operations
Business Unit: Innovative Medicines
Location: USA
Site: Indianapolis
Company / Legal Entity: AAA USA Inc.
Functional Area: Technical Operations
Job Type: Full time
Employment Type: Regular
Shift Work: No

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Production Technician, Am Shift

Job Description

Summary

Key Responsibilities

Essential Requirements

Compensation and Benefits

Why Novartis?

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