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...
Senior Process Engineer
The Process Engineer will execute engineering activities (design, implementation, maintenance, etc.) within technical area of expertise by using reliable and cost-effective technical solutions, ensuring technical quality to enable the overall site / project objectives. Responsible for execution of maintenance and calibration activities and commissioning activities for projects at site level. Execute for design, execution and hand-over projects within cost, time schedule, quality and functionality within technical area of responsibility. Flexible to support second shift when needed to ensure the project's critical timeline is maintained.

Major Accountability:
Guide and supervise onsite installation and commissioning activities of equipment/system
Install subsystems owned by Novartis in production line
Implement equipment optimizations and modifications
Participate on the assessment or implementation of special projects or initiatives with cross-functional teams.
Lead complex root cause investigations
Performs change assessments
Preparing, scheduling, coordinating, and monitoring of assigned engineering projects.
Reviews equipment and engineering systems to support root cause analysis investigations and trend investigations.
Second line escalation in case of equipment failures
Driving continuous improvement from an asset perspective
Reducing safety risks through simplification and error proofing machines
Improving equipment reliability through equipment design modifications
Maintain Master Instrument Inventory (MII) and Master Equipment Inventory (MEI).
Set-up maintenance for new equipment (incl. spare part needs).
Assist with preparation of plans for maintenance / calibration / qualifications.
Manage technical / engineering changes: originate Change Request, approve Change Request, close Change Request.
Assist with preparation of estimates for bids and proposals.
Act as SME to review/approve DQ, IQ, OQ and PQ protocols and reports.
Perform GMP risk assessments (incl. Sensors SRA).
Independently manage and resolve deviations on equipment and systems.
Support internal and external audits.
Provide technical trouble shooting during Startup, PQ and validation activities
Develop periodic requalification plan
Execute periodic requalification plan
Utilize automation (Scada / PLC's / Control Networks hardware) for data gathering and equipment optimization opportunities
Assist in troubleshooting of process / plant equipment including isolator, filling line and utilities.
Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications and update as needed.
Write/revise accurate engineering documents for various production system.
Supply information and technical data for securing spare parts.
Provide responsive customer support with emphasis on customer satisfaction.
Perform startup and commissioning activities as required.
Support and/or perform investigations / deviations from an engineering/maintenance perspective and help with data for timely closure of deviations and CAPAs
Complete and provide accurate documentation, as required in cGMP operations.
Use of CMMS system for documentation of relevant work.
Other related duties as assigned.

Minimum Requirements:
Bachelor’s Degree in Engineering or related field is required
5+ years of relevant experience in a GMP environment is required
Previous experience in the pharmaceutical industry is required.
Pharmaceutical aseptic filling experience is preferred
Vendor management experience is a plus
Knowledge/experience in automation or computer system validation (CSV) is a plus
Experience managing projects is preferred

Location: Indianapolis, IN (Onsite)
Pay Rate: $54.14 - $87.86/hr based on skills/qualifications (W2 Only)
Contract: 12 months
Health, dental, vision, 401k - if eligible

~~~~Please apply today:

Why Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

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.

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.

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