Senior DeltaV Specialist – Manufacturing Automation

Job Description

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 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 Specialist level will serve as a team member of the MACS Center Basis of Design Phase 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 collaborate with the development engineers & chemists, compliance representatives, and other team member. 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.

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 supports 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.

Education Minimum Requirement: 

• Bachelor’s degree in Automation, Engineering, Science, or Computer-Programming related degree with minimum of 5 years relevant experience, or a Masters degree with 3 years of relevant experience

Required Experience and Skills:

• 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

• 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 of 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.