Job Description

~~~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

Ready to work with/through Magnit at Novartis? Please read on... 
Process Expert Deviation Investigator (Mon-Fri 8am - 5pm)

As a Process Expert you will provide front line support to manufacturing, working with the production team to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert(SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions.

Key Responsibilities:
Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols,and other documentation as needed.
Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures(SOP), batch records and white papers.
Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs.
Authoring/Owning investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging.
Ensure processes are always inspection ready.
Support process optimization and new technology introduction for continued productivity improvement, as appropriate.
Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects.
Provide guidance and support to production team through training and knowledge sharing.
Will demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures.

Role Requirements
Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.
3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
Proven process understanding (Pharma, GMP, Regulatory aspects).
Strong awareness of quality issues. Compliance investigations experience required.
Excellent technical writing skills

Desirable Requirements:
Previous Radio pharma experience a plus
Prior leadership and/or high cross-functional experience preferred.

Location: Onsite role Indianapolis, IN (Mon-Fri 8am - 5pm)
Pay Rate: $30 - $40 based on skills and qualifications
Contract: 6 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 [email protected] or 1.862.778.5441.

Commitment to Diversity and Inclusion / EEO

 

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