Automation Engineering Manager

365 days a year, we aspire to be the best manufacturer of Cell & Gene therapies to ensure our patients have the treatments they need to live longer, healthier lives.
The Automation Engineering Manager will be the lead for automation systems, interfaces and equipment. Responsible for management of the automation systems across the facility (building/process/laboratory). Ensures the site's compliance with internal GMP’s, CSV and external regulatory requirements.

Your responsibilities will include, but are not limited to:

• Management of the automation systems at the site including building management systems (BMS), room monitoring systems (RMS), process and laboratory equipment automation.
• Manage the overall automation asset care strategy for the site including upgrades, maintenance contracts and changes.
• Responsible for the management, support and execution of automation qualification as well as the resolution of all automation-related issues.
• Update and develop User Requirement Specifications, Functional Specifications, Design Specifications, Operation and Maintenance for the new and existing control systems.
• Devise new approaches to complex problems through adaptations and modifications of standard automation technical principles.
• Work closely with multiple disciplines, including manufacturing, engineering, utility operations, maintenance, quality assurance, and qualification to manage a diverse portfolio of projects
• Manage resources to plan, develop, and execute automation projects from start-up to completion.
• Establish, monitor and maintain a stable and productive automation environment through oversight, preventative maintenance, and standard operating procedures.
• Manage, and oversee project work plans, meetings, decisions, project deliverables, progress reports, schedules, cost tracking and other pertinent reports.
• Provide and/or coordinate vendor training to new users of automation systems.
• Ensure cGMP and CSV compliance with all internal Novartis and external regulatory requirements.
• Work collaboratively to address data integrity issues.
• Initiate and execute change control activities for automation systems.
• Assist department head to ensure compliance with Novartis Information Security Risk Management policies.
• System/Application owner for automation systems interfacing with IT on server, network and infrastructure.
• Manage resources (external) for providing technical support to operations and support personnel.
• Own and close corrective actions related to the automation systems;

This position will be located in Morris Plains, NJ and will not have the ability to be located remotely.


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What you'll bring to this role:

• Bachelor’s Degree in Engineering or related scientific field
• Fluent in speaking /writing in English
• A minimum of 7 years experience with automation systems
• Experienced in a GMP regulated environment (pharmaceutical preferable)
• Experience with automation systems such as PI Data Historian, DeltaV
• Knowledge of IT infrastructure/networks related to automation systems
• Familiarity with industry standards 21 CFR Part 11, Validation, and GAMP
• Must be able to work in controlled environments requiring special gowning
• Ability to work independently with minimal direction Self-directed and able to manage competing priorities
• Must be able to work well with others in a team environment strong computer skills
• Ability to focus on a variety of issues and drive to results
• Ability to interact with a variety of organizational levels and foster cross-functional and cross-cultural teamwork

Desirables:

• Experience with automation systems such as Continuum, Siemens, PLCs, etc is preferred
• Working knowledge of P&ID and loop diagram standards; temperature, pressure, flow, weight, humidity, and other instrumentation is preferred

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 our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com or call 1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600 per year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Operations

CELL & GENE THERAPY

USA

Morris Plains, NJ

Novartis Pharmaceuticals

Technical Operations

Full Time

Regular

No

No