Sr. Operational Technology (OT) Engineer - România | Merck (2024)

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 Degree in any engineering discipline is required.
  • 5+ years of experience in definition, design, development and implementation of production control systems for advanced technology facilities, OT system design and project execution of digitalization projects
  • Advanced knowledge in OT systems and orchestration such as DCS, PLC, HMI, Data Historians, MES/EBR, Batch Systems, LIMS or any similar system
  • Hands on experience in diagnosis, maintenance, installation and setup of OT systems hardware and software

Preferred Qualifications:

  • PLC Programming, Motion Control and HMI experience (AB PLCs and Rockwell Software products)
  • Experience in a commercial medical, biotechnology, Bio-pharmaceutical, pharmaceuticals, life sciences manufacturing environment is highly preferred.
  • In depth knowledge of Rockwell Software packages or similar system is highly preferred (Transaction Manager, Metrics, Asset Center, etc.)
  • Able to self-direct toward individual milestones as part of team projects with a strong sense of responsibility, urgency, and high energy with a positive behavior.
  • Strong communication and interpersonal skills, ability to collaborate across disciplines.
  • Highly motivated, adaptable, and self-directed.
  • Strong communication and organizational skills.
  • Ability to work with other site, cross functional teams and to collaborate and work with Global Life Sciences OT and Operations team.
  • Knowldege of implementing layers of protection for cyber security, OT and IT
  • Advanced knowledge in OT infrastructure design, software engineering and IT security


What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of our diverse team!

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

Sr. Operational Technology (OT) Engineer  - România | Merck (2024)
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