Process Expert

Novartis

381d • $84,000 - $126,000

About The Position

The Process Expert at Novartis Services Incorporated will play a crucial role in supporting manufacturing operations by providing technical and procedural guidance. This position involves acting as a Subject Matter Expert (SME) for production processes, leading investigations into deviations, and identifying opportunities for operational improvements. The role is essential for ensuring compliance with quality standards and for training team members in best practices. The Process Expert will work on-site in Millburn, NJ, during a Wednesday to Saturday shift from 1 PM to 11 PM.

Requirements

• Bachelor's Degree is required, with a scientific focus preferred.
• 3+ years of previous GMP experience is required.
• Previous experience in the pharmaceutical industry is required.
• Previous experience leading investigations is required.
• Previous radiopharmacy experience is preferred.

Nice To Haves

• Change Control
• Chemical Engineering
• Continual Improvement Process
• Efficiency
• Flexibility
• Good Documentation Practice
• Knowledge Of CAPA
• Knowledge Of GMP
• Lean Manufacturing
• Manufacturing Process
• Physics
• Process Control
• Productivity
• Risk Management
• Root Cause Analysis (RCA)
• Technology Transfer

Responsibilities

• Provide front line technical and procedural support to manufacturing, focusing on safe and timely batch production.
• Author investigations for product and non-product deviations and conduct manufacturing investigations for OOE, OOS, and OOT results.
• Work cross-functionally to assess deviation impact and identify root causes, ensuring timely batch releases through robust investigations.
• Identify opportunities for process, operational, and quality improvements in conjunction with the Manufacturing Team and Operational Excellence Team.
• Provide timely support for process technology transfer activities from clients/3rd parties.
• Develop and provide training to the Cell Processing team and own the Training Curriculum for the Process Expert position.
• Maintain processes at inspection readiness level and support internal and external audits.

Benefits

• 401(k) eligibility
• Various paid time off benefits including vacation, sick time, and parental leave
• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Full range of medical benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree