CSV / CQV Engineer

:::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...

Team and Project Support

Duties:

• Write, summarize, and drive project change controls for cleanroom, clean utilities, manufacturing & lab equipment.
• Laydown clear plan for drafting, reviewing, and pre-approving commissioning and qualification documents for manufacturing and lab equipment and other associated systems.
• Execute commissioning and qualification activities and resolve deviations (if any) in a timely manner.
• Work with project team to ensure all activities are carried out in accordance with the project timeline.
• Ensure all documents are written in accordance with Novartis Quality Manual and procedures.
• Ensure all equipment related drawings are available and updated in the commissioning and qualification documents.
• Develop required procedures and handover to system owner in a timely manner.
• Coordinate with various internal and external stakeholders to refine the list of activities scheduled and maintain the best possible granularity in the schedule.
• Ensure project activities are sequenced in the most logical manner ensuring completion of pre-requisites timely and orderly.
• Escalation of potential issues that may arise from time to time during the execution of project activities and collaborate with the cross-functional teams towards resolution.
• Be the go-to person in case of requests with regard to cleanroom or clean utilities.
  
  
  

Major Accountabilities

• Drafting, reviewing and pre-approval of protocols in a timely manner
• 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:

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

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 organisation.
• 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
• Fexibility and adaptability to change.
• Learning agility and ability to work in a complex and rapidly changing envirnomnemt.
• Basic uderstanding of regulatory and legal requirements
  
  
  

Location: Indianapolis, IN (Onsite)

Pay Rate: $50-$80/hour

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 or 1.862.778.5441.

Commitment to Diversity and Inclusion / EEO