Dec 06, 2022

Job Description

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry!

The Manager, Automation & Calibration Engineering is responsible to provide leadership and management of design, development, and implementation of automation and calibration systems including engineering, start-up, commissioning and qualification of process control systems to support Dispensary, Compounding, Packaging, Warehouse, and QC lab operations for the Fougera manufacturing facilities. Duties include engineering staff management, tracking financial success, providing fit-for-purpose automation systems, planning for system maintenance, and ensuring compliance with Novartis quality requirements. Create the roadmap for the Fougera Automation Systems including determination and specification of system architecture, site goals, and compliance strategies relative to automation; act as subject matter expert in automation (PLCs, HMIs, Data Historian, SCADA, MES, etc.); and lead automation engineers & technicians responsible for supervising the design, start-up, and maintenance of the automation systems for the facilities.
• Ensure all company and site Engineering policies and procedures are adhered to.
• Ensure all work carried out and equipment installed is safe, effective and in compliance with the appropriate industry standards.
• Manage, lead, monitor, motivate, and mentor the Automation & Calibration Engineering Department Staff.
• Develop strategic objectives for department and implements according to pre-established plans.
• Manage automation & calibration engineering staff, vendors, and engineering/commissioning contract staff
• Implement and coordinate activities associated with staffing, training, purchasing, budgeting, compliance, reporting and quality of service
• Through automation engineering and technical support team, provide support for end users through life-cycle document reviews, training, and turnover of systems to operations
• Manage automation engineering staff project performance from inception thru completion relative to automation/control system fabrication, installation, validation, and in accordance with good documentation practices
• Ensure compliance with testing of all levels of software in the life cycle of a project and the preparation of functional specification documentation and software design specifications
• Initiate automation and control projects based on compliance, corporate directives, safety, efficiency, and/or improvements, keeping current within guidelines of cGMP, FDA, OSHA, NFPA or other governmental agencies
• Responsible for budgeting, monitoring, forecasting, and reporting costs and scheduling (preferred).
• Research new technologies for the on-going and continuous operation of all Process, Packaging, and Facility automation and controls (preferred).
• May require travel to industry shows and expositions, or to vendors to perform Vendor Evaluations, Design Reviews, and Factory Acceptance Testing (FAT).
• Perform any other activities as directed by the Director of Engineering.
• Support and Meet Departmental, Plant and Corporate HS&E goals. Work in a safe and efficient manner.
• Adheres to all applicable procedures, cGMP’s, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.).
• Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.

Position includes working in all areas of two facilities, including office areas, production, warehousing, laboratory, and utility rooms. Climbing ladders, stairs, working/climbing through construction areas, and some lifting to facilitate project requirements is required.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

• BS is required. Electrical Engineering, Process Engineering, or relate-Engineering field is highly preferred.
• 6+ years of experience with automation and control systems design, building, and installation in pharmaceutical manufacturing or food industry manufacturing or related experience is required.
• 2+ years of supervisory experience is required
• Process Automation Experience including SCADA, MES, and/or Data Historian. Understanding of PLC ladder logic programming, Building Management Systems.
• Proficiency with Microsoft Office is required.
• Visio & AutoCAD experience is preferred.
• Experience with pharmaceutical industry standards and requirements (Minimum US GMP) and Automation Industry Standards such as GAMP (Good Automated Manufacturing Practice) is highly preferred.
• Experience with ANSI/ISA S88 Batch Control, and ANSI/ISA S95 is preferred.
• Understanding of business systems (SAP, LIMS etc.) and familiar with Engineering software systems (CAD, project management, maintenance management and calibration).
• Excellent public speaking skills and ability to conduct effective presentations is preferred.
• Experience with engineering design, construction, start-up, commissioning and validation relative to complex automation systems is preferred.

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 Sandoz!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] 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.
Novartis Technical Operations
Hicksville, NY
Facilities & Administration
Full Time
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Manager, Automation & Calibration Engineering

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