Senior Specialist, Manufacturing Automation Engineer (On-Site)

MSD•Rahway, NJ

3d•Onsite

About The Position

The Enabling Facilities (EF) group within the Chemical Engineering Research & Development (CERD) Department is seeking a highly motivated individual to work in a fast-paced job that provides a high degree of technical and project management responsibility. The Senior Specialist – Manufacturing Automation position will report to the Associate Director, Engineering, Automation Lead position and will be a member of the EF Team at the Rahway NJ facility. EF is responsible for development of new technologies/capabilities, execution of capital and non-capital improvement projects, and the automation system assets spanning production, utility systems and associated infrastructure. Responsibilities of the Senior Specialist – Manufacturing Automation include the following: The automation engineer role at the Senior Specialist level will serve as technical SME and capital team member supporting the Modality Agnostic Chemistry Scaleup (MACS) Center. This is a new potent, multi-modality (small molecule, macrocyclic peptides, bioconjugates) Drug Substance development and GMP clinical manufacturing plant currently planned in Rahway, New Jersey. The automation engineer role at the Senior Specialist level will serve as a team member of the MACS Center design, commissioning, and qualifications teams; and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network. As the facility is currently under construction, the selected candidate will contribute to automation equipment and software design, system commissioning/qualification, as well as other automation areas critical activities to enable facility startup. The selected candidate is expected to be a key part of the MACS Project Automation Team and foster a culture of collaboration, learning and innovation. This will also require close collaboration with the development engineers & chemists, compliance representatives, and other team members. This role will be part of the broader Enabling Facilities Automation Team supporting facility operations, process development activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities, and will help to develop future strategies for support optimization and expansion. Key Responsibilities: The automaton engineer will troubleshoot automation and instrumentation issues, perform root cause analysis and implement corrective/preventive actions to improve reliability, safety, and energy performance. Develop deployment strategies for various systems in the facility. Manage system patches, firmware upgrades, backup/restore strategies, and cybersecurity hardening aligned with corporate policies. Ensure robust data integrity and audit trails suitable for operations. Serve as a technical lead for capital projects work to design, install, and commission new equipment to support. Write, review or execute test documents. Provide on-call support rotation for facility operations as needed. Collaborate closely with operations, maintenance, and IT to align automation solutions with uptime, safety, sustainability, and efficiency goals. Support continuous improvement initiatives: standardization, modular code libraries, alarm rationalization, and enhanced diagnostics/monitoring for utilities equipment. Additional Supported Areas As required and in addition to support of current capital projects the Senior Specialist may provide direct support to other areas such as: Small Scale Organics Pilot Plant (SSO): The SSO uses an Emerson DeltaV Distributed Control System. The SSO is a Good Manufacturing Practice (GMP) manufacturing facility in the Process Research and Development (PR&D) organization. The pilot plant’s mission is to serve as PR&D’s internal node for small molecule drug substance clinical manufacture, and as preferred site for first pilot of commercial small molecule processes, enabling gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing technology/processes, training opportunities for improved manufacturing process development and seamless tech transfer to commercial sites. Hazardous Reactions Lab (HRL) : The Hazardous Reactions Lab (HRL), or Bldg. 801, uses GE PLC 90-30 processors and Genius I/O blocks. The Graphical interface is an Intellution iFix platform run on redundant SCADAS and seven workstations, with historical data collected on a local historian as well as OSI PI. The B801 High Pressure Lab and Low-Pressure Lab Automation Systems support Hydrogenation Hazardous reactions using a wide variety of vessels and equipment. The High-Pressure Barricades Cells are divided up into ten cells where each cell is electrically classified as Class 1 Division 2 Hazardous Area, Group B.

Requirements

Pharmaceutical Operations experience, in a GMP Pilot Plant, Manufacturing environment or related facility.
Ability to understand, update, design and implement required code modifications in DeltaV or PLC based systems (i.e., Rockwell)
Experience with automation system design, start-up and/or qualification.
Experience providing project level direction to contractors and/or third-party vendor staff.
Knowledge of all the details of automation including wiring, electrical, device selection and integration.
Experienced problem solver/troubleshooter, skilled in root cause analysis.
Ability to prepare Standard Operating Procedures (SOP) and cGMP documents.
Experience with Quality Systems.
Experience in supporting compliance investigations and change management activities.
Familiarity with US and EU GMP and Safety compliance regulations.
Effective interpersonal and communication skills, both verbal and written.
Excellent organizational skills to multi-task.
Desire and willingness to learn, contribute and lead.
Project Management experience with demonstrated skills, and ability to lead larger teams in complex solution and problem resolution.
Candidates must be able to work independently and as part of a cross-functional team.
Strong analytical thinking and technical writing skills.
Proficient in MS Office Platform and document storage systems.
A high level of innovation, creativity, and self-initiative.

Nice To Haves

Experience with DeltaV Live and Batch, Charms I/O, and wireless technologies.
Ability to perform PID tuning of instrumentation & control loops.
Working knowledge of general OPC and Modbus interfaces.
Knowledge of PLCs, HMIs or other types of Control Systems including Rockwell and Siemens.
Subject Matter Expert on Control Systems.
Understanding of Object-Oriented languages with experience programming systems in a professional setting.
Strong background in IT systems; specifically, integration of Automation systems with IT systems.
Networking experience; working knowledge of Enterprise Networking and local control networks.
Experience providing technical mentorship of less experienced engineers and training if operations personnel in use and troubleshooting of automated systems.
Experience with coordinating maintenance activities around processing activities to support reliable facility operation.
Experience in Process Hazard Analysis (PHA) and/or Level of Protection Analysis (LOPA).

Responsibilities

The automaton engineer will troubleshoot automation and instrumentation issues, perform root cause analysis and implement corrective/preventive actions to improve reliability, safety, and energy performance.
Develop deployment strategies for various systems in the facility.
Manage system patches, firmware upgrades, backup/restore strategies, and cybersecurity hardening aligned with corporate policies.
Ensure robust data integrity and audit trails suitable for operations.
Serve as a technical lead for capital projects work to design, install, and commission new equipment to support.
Write, review or execute test documents.
Provide on-call support rotation for facility operations as needed.
Collaborate closely with operations, maintenance, and IT to align automation solutions with uptime, safety, sustainability, and efficiency goals.
Support continuous improvement initiatives: standardization, modular code libraries, alarm rationalization, and enhanced diagnostics/monitoring for utilities equipment.