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Sr. Operational Technology (OT) Engineer

Merck Group
United Statesfull_timeVerifiedPosted 7 Jun 2024

About the role

 

Work Your Magic with us!  

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

Your Role:
We are seeking an experienced Sr. Operational Technology Engineer to join our Mobius Engineering Automation Team in Danvers, MA. As the Sr. Operational Technology Engineer, you will be part of the Mobius Engineering Automation Team and responsible to design, qualify, deliver, and maintain process control systems for manufacturing and laboratory operations with a focus on automation equipment development, implementation, and validation to join our Mobius Engineering Automation Team in Danvers, MA. Mobius Engineering is focused on the production of single-use biopharmaceuticals assemblies. 

 

This position is primarily responsible for providing innovative automated solutions to existing manual processes through collaboration with equipment suppliers and internal colleagues. This individual will be the point of contact for all plant-related projects and incidents from an OT perspective. This role will also be a key contributor to the design and implementation of the automation and direct control (DCS) or SCADA environment at the site.

 

Key Responsibilities:

  • Act as system owner and subject matter expert for a collection of systems managed at the site
    • Automation Network and Infrastructure / ISA95 
    • Human-Machine Interfaces (HMIs/control consoles)
    • Data Historian (OSIPI)
  •  Lead systems maintenance (Inc. patch management, system updates), respectively build and secure dedicated expertise, while optimally coordinating and executing key support for update, incident and change management 
  • Define the systems lifecycle strategy, together with stakeholders and external maintenance partners
  • Ensure compliance with applicable prevention, quality and documentation good practices and procedures.
  • Support Automation Project Engineers in various projects by making sure there is a strong connection to the operational environment and all proper handover preparations into post-project operation
  • Responsible for maintaining vendor relationship through technology lifecycle to ensure minimal disruption to business operations, version upgrades, obsolecense, and service bulletins
  • Responsible for managing team in project definition, budgeting, planning and implementation phases, when needed.
  • Contribute to Technical Risk Reviews (TRR) for projects in your respective district that involve ICT/Networking/Cyber Security
  • Site OT systems typically consist of the central manufacturing and laboratory process control systems, data historian, equipment PLC/SCADAs and interfaces to PIM-, LIM- or Manufacturing Intelligence systems.
  • Interface, maintain communication and collaborate with local and global IT organizations for IT owned systems and applications revision and upgrades that support the manufacturing and laboratory operations on site. 
  • Develop equipment documentation to meet GMP requirements, i.e.: URS, FAT, Equipment IQ/OQ/PQ, PM, SOPs. Perform IQ/OQ/PQ and provide maintenance support on instruments as needed.
  • Utilize a strong understanding of PLC programming, Networking, electrical and controls systems to ensure the operability of existing production machines (PLC-Based, Rockwell), and to build the control systems for new machines. The candidate must be able to create PLC programs or make changes to existing programs to accomplish this function.
  • Critically review and analyze sub-supplier’s deliverables (Codes, Schematics, and Documentations).
  • Create and manage network topology and I/O lists.
  • Provide guidance for the safe installation, maintenance and troubleshooting of electrical control systems, including components of machinery and equipment.
  • Observe all regulatory requirements GMP's, ISO, internal policies. Detailed knowledge of NFPA 79, ISO 13849-1, ANSI-95 is highly preferred.
  • Observe and implement Configuration Management Principles to maintain the validated state of existing validated automated manufacturing equipment.
  • Act as the subject matter expert for all automation activities (Change control, validation, etc.).
  • International Travel up to 10-20% as need for this role.
  • This individual requires to be onsite, and this is not a remote position.

 

Who You Are:
Minimum Qualifications:

  • Bachelors Degre

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Company

Merck Group

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