Qualification Engineer - Novartis

~~~Please note: This is a temporary contractor opportunity at Novartis ~~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! 
  
Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit www.magnitglobal.com 

Ready to work with/through Magnit at Novartis? Please read on...
Qualification Engineer
Job Purpose:
Responsible for ensuring compliance to the regulatory requirements of the facilities, utilities, equipment and analytical instruments qualification processes and activities performed in the Novartis, Morris Plains, 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), Manufacturing, Science and Technology (MS&T), Operations (OPS), Quality Control (QC) and Quality Assurance (QA) departments.

Major Accountabilities:
Support internal and external audits by taking lead role on validation/qualification discussions.
Provides leadership and guidance to complex qualification activities and projects
Manages multifaceted qualification activities with limited oversight
Coordinates Qualification activities in compliance with corporate policy, local procedures and regulatory expectations
Collaborates with PU, MS&T, OPS, QC and QA Teams on 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 and Performance Qualification protocols
Assists PU, MS&T, OPS, QC and QA colleagues, as necessary
Ensures that all activities are in compliance with cGMP, Health Authority regulations and the Novartis Policies
Determines of Qualification requirements based on a worst case matrix approach for the site
Provides qualification solutions that meet regulatory requirements within budget, where applicable.
Supports/assists 3rd party/ vendor qualification activities, if applicable.
Support qualification/validation projects as allocated.
Provides guidance and support of less knowledgeable qualification/validation associates

Key Performance Indicators:
Conformance to the qualification KPI’s
Adherence to project schedule restrictions

Education: 
BS degree in Scientific discipline or other related field with significant prior experience (10+ years).

Experience:
10+ years of Pharmaceutical industry qualification experience with a strong focus on Equipment and Analytical Instruments.

Location: Morris Plains, NJ (Onsite)
Pay Rate:$94.18-$118.69/hour based on qualifications (W-2/only)
Contract: 12 months
Health, dental, vision, 401k

Why Novartis? 
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. 
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. 
We believe we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! 
Imagine the impact you could make here at Novartis! 
  
Commitment to Diversity & Inclusion: 
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve. 

To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all. 
  
Accommodation: 
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at directsourcing@magnitglobal.com. 

Commitment to Diversity and Inclusion / EEO