May 16, 2022

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The Senior Expert, Engineering will be responsible for ensuring compliance to the regulatory requirements of the facilities, utilities, equipment and analytical instruments qualification processes and activities performed in the Novartis, Cell and Gene Therapy East Hanover, NJ facility. Recommends and implements improvements of the qualification process. Performs a variety of routine and non-routine tasks related to facilities, utilities, equipment and analytical instruments qualification, as managing and overlooking qualification projects and changes. Prepares risk and impact assessments and other evaluations. Supports Process Unit (PU), Technical Development (Tech Dev) Operations (OPS), Analytical Operations formerly known as Quality Control (AO) and Quality Assurance (QA) departments.

Your responsibilities will include, but are not limited to:
• Coordinates Qualification activities in compliance with corporate policy, local procedures and regulatory expectations
• Coordinates and develops with PU, Tech Dev, OPS, AO and QA teams qualification projects and plans and identifies the “critical to quality” parameters impacting qualification activities
• Prepares Qualification Master Plans, Risk and Impact Assessments, Protocols and Summary Reports and coordinates review and approvals of the documents
• Authors/reviews/updates/assists in developing departmental standard operating procedures (SOPs) and qualification programs
• Conducts field execution of Installation, Operational, Performance Qualification and Computer System Validation (CSV) protocols
• Assists PU, Tech Dev, OPS, AO and QA colleagues, as necessary
• Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Novartis Policies
• Determines Qualification requirements based on a worst case matrix approach for the site
• Supports/assists 3rd party/ vendor qualification activities, when applicable
• Support qualification/validation projects as required

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of 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, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What You'll Bring to the Role:

• Bachelor's degree in relevant field with 7 years’ experience, Master's degree , in relevant field, with 5 years’ experience or PHD, in relevant field with 3 years’ experience. A combination of equivalent skills and education will be considered.
• Technical skills in the understanding of pharmaceutical facilities, utilities, manufacturing, and laboratory equipment/instruments operation
• Highly knowledgeable in cGMP and regulatory requirements, including CSV requirements and 21 CFR Part 11 compliance
• Strong technical writing skills for generating high quality protocols & technical reports
• Capable of working cross-functionally, a team player
• Good project management skills, decision-making ability
• Good communication and negotiations skills
• Must be able to work independently with a minimal supervision
• Detailed understanding of quality assurance standards, cGMP principles, theories, and techniques
Global Drug Development
East Hanover, NJ
Technical Operations
Full Time
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Senior Expert, Engineering (Equipment & System Validation)

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