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...
Equipment Qualification Expert

Job Details:
• Writing equipment qualification and validation master documents e.g. User Requirements, Design Specifications, Configuration Specifications, Software Specifications etc.
• Generating equipment commissioning and qualification protocols including SAT, IQ, OQ & PQs preferably in paperless system (KNEAT)
• Execution of qualification and validation test scripts in line with the qualification/validation plan, protocols using paperless qualification software, Kneat.
• Following Novartis procedures of qualification/validation as well as good documentation practices.
• Recording excursions / deviations from the protocol (if any) and performing root cause analysis to determine root cause and resolutions,
• Working with Novartis associates in engineering, quality and project management to timely resolve all issues and closed documents on time
• Writing validation summary reports and release of systems to next step.
• Working with equipment vendors and other technical support to complete qualification work seamlessly and timely
• Adherence to project expectations in terms of timeline and deliverables.
• Adherence to Novartis procedures of HSE, GMP as well as project management and compliance.

Major Accountabilities
• Drafting, reviewing and pre-approval of protocols in a timely manner
• Adherence to Novartis GDP (Good Documentation Practices), Data Integrity and other relevant SOPs.
• Adherence to overall project schedule
• Ensure all commissioning and qualification protocols are compliant to Novartis quality manual and site procedures.
• Fosters an environment that enables the most efficient and effective work processes to achieve project objectives and milestones.
• Implementation of and compliance with all the guidelines and requirements for safe work, environment protection and property protection.

Key Performance Indicators – KPIs
• Timely and complete commissioning and qualification packages for the systems.
• Adherence to project schedule of activities
• Compliance with Novartis Quality Manual and RLT Site SOPs.

Education:
Minimum: Degree in Science and Certification in Project Management (preferred). Extensive project management experience may substitute the need for a degree.

Languages:
Fluent in English

Experience:
• High performing, credible professional, with a track record of successfully coordinating cross functional projects and teams.
• Cultural awareness and sensitivity; ability to network and communicate with various levels of the organization.
• Fair understanding of technical and business principles and processes of medicine manufacture and regulatory requirements attained in various functions / areas of pharmaceutical industry.
• ?6 years project management experience, of this, ?2 years within similar role and complexity; experience in Health Care / Pharma Industry preferred
• Strong planning capabilities (decision making, result oriented, challenge capability, negotiation, supporting others, stakeholder mgt, change mgt, working in a matrix organization)
• Strong proficiency in Microsoft Excel, PowerPoint, and MS Project
• Strong verbal communication and presentation skills
• Flexibility and adaptability to change.
• Learning agility and ability to work in a complex and rapidly changing environment.
• Basic understanding of regulatory and legal requirements

Location: Indianapolis,IN (Onsite)
Pay Rate: $40 - $60/hr based on experience and qualifications (W2 Only)
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 directsourceproteam@prounlimited.com.

Commitment to Diversity and Inclusion / EEO

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