Senior Engineer / Equipment Qualification

Job Description Summary

This position will be located at East Hanover, NJ site and will not have the ability to be located remotely.

"Please note that this role would not provide relocation and only local candidates will be considered."

The Equipment Qualification Engineer is responsible to ensure the qualification program for facilities,

utilities, equipment and analytical instrumentation at the Novartis, Cell and Gene Therapy East Hanover,

NJ facility is executed in accordance with internal policies, procedures and regulatory agency

compliance. The Equipment Qualification Engineer recommends and implements improvements of the

qualification process and performs a variety of routine and non-routine tasks related to the GMP

compliance for facilities, utilities, equipment, and analytical instrument qualification. Responsibilities also

include oversight of qualification program service provider deliverables, projects, and program changes.

Reviews and approves qualification documents such as installation, operational, performance

qualification (IOPQ) and computer software validation (CSV) protocols, reports, traceability matrix (TM).

Prepares and / or approves risk and impact assessments, validation master plans (VMP) and other

evaluations. Supports Production Unit (PU), Operations (OPS), Quality Control (QC) and Quality

Assurance (QA) departments. Plans and manages qualification activities of manufacturing equipment,

laboratory instruments, facilities, and utilities. Ensures efficient, timely, GMP and compliant execution of

qualification activities

#LI-Onsite

Key Responsibilities :

• Manage qualification activities in compliance with corporate policy, local procedures, and regulatory

expectations.

develops with PU, OPS, QC and QA teams' qualification projects and plans and identifies the "critical to

quality"parameters impacting qualification activities.

summary reports and coordinates review and approvals of the documents.

validation (CSV) protocols.

and qualification programs.

with cGMP, Health Authority regulations and the Novartis Policies.

Specification (OOS), Out of Expectations (OOE), product deviations or rejects related to equipment,

laboratory instruments, facilities, and utilities in area of responsibility.

Job Description

Requirements :

Novartis Compensation and Benefit Summary : The pay range for this position at commencement of employment is expected to be between $114,100 / yr and $211,900 / yr; however, while salary ranges are effective from 1 / 1 / 25 through 12 / 31 / 25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills, and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and / or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department / team performance, and market factors.

Company will not sponsor visas for this position.

Novartis is unable to offer relocation support for this role : please only apply if this location is accessible for you.

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$114,100.00 - $211,900.00

Skills Desired

Agile (Programming Methodology), Architectural Engineering, Aws (Amazon Web Services), Business Continuity, Business Networking, Change Control, Computer Science, Construction Management, Cost Management, Flexibility, General Hse Knowledge, HVAC (Heating Ventilation And Air Conditioning), Including Gdp, Installations (Computer Programs), Knowledge Of Capa, Knowledge Of Gmp, Knowledge Of Relevant Tools And Systems , Manufacturing Production, Project Commissioning, Project Engineering, Project Execution, Risk Management, Root Cause Analysis (RCA), Software Development, Total Productive Maintenance