Director, Automation Leader - Rahway, United States - Merck

Description

Job Description

Position Description: Director –Automation Leader (M3)

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 management responsibility.

The Director – Automation Leader position will report to the Senior Director, Enabling Facilities, and will be a member of the EF leadership 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. The Automation Leader plays a key role in developing and fostering both the organizational design of the Automation group and the overall department strategy. The Automation Leader will direct a team of automation engineers that administer automation systems residing in both our Research & Development Division, API Operations and Rahway Site Operations.

The Team supports facility operations, process development activities, compliance investigation, change management and the authoring of GMP documentation in any of our enabling facilities.

Supported Areas

The Automation Leader will be responsible for Automation Systems at the Rahway Site inclusive of:

Modality Agnostic Chemistry Scale Up (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 Leader will serve as a key team member of the MACS Center Basis of Design, Detailed Design and Execution phases of the project, and will go on to support new and/or existing facilities across the Small Molecule Process Research & Development (SM PR&D) network. MACS will use an Emerson DeltaV Distributed Control System and will be employing Safety Instrumented Systems and Environmental Monitoring as part of the engineering solution. The Automation team is also evaluating applicability of MES and helping to define the digital strategies to be employed to ensure data capture, availability and contextualization. As the facility is currently under construction, the Automation team reporting to this position will directly contribute to automation equipment and software design, system commissioning/qualification, as well as other critical activities to enable facility startup and operational readiness while fostering a culture of collaboration, learning and innovation. This will also require close collaborate with the development engineers & chemists, compliance representatives, and other team members.

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 SM PR&D organization. The pilot plant's mission is to serve as our Company'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.

Site Operations (GWES): The Automation Lead will manage SMEs who support several automation systems across the Rahway Site including ABB Distributed Control Systems, utility metering systems and the REES Environmental Monitoring Systems. This role will collaborate with Global Workplace Enterprise Solutions (GWES) in prioritizing a portfolio of automation improvement projects (capital/non-capital) supporting API Operations and the Rahway Powerhouse/Utilities/Environmental Operations space, interfacing with key partners and area leadership to ensure delivery of business objectives, including operational efficiencies, compliance, energy savings initiatives, improved reliability, operability and maintainability.

Additional Responsibilities/Expectations

• Help shape departmental strategy including defining enabling facility and equipment technologies, leveraging innovative solutions, and enhancing capabilities and business processes.
• Recruiting of Automation staff (both FTE and non-our Company) to sustainably meet the department's objectives including a heavy capital workload as well as upgrades and maintenance of automation systems.
• Committed to continuously improving and optimizing Automation system performance, ensuring staff identify and propose opportunities with input from key stakeholders.
• Collaborating and communicating effectively with partner groups including IT, EHS, Quality, Site facilities and end users.
• Committed to improving the Automation / IT service model for the site, maintaining close interfaces with GWES and IT.
• Ensuring staff maintain compliance with, and administration of, Automation SOPs, SDLC requirements, and execution of automation change controls and quality investigations.
• Providing oversight to ensure development and implementation of maintenance strategies for GMP and non-GMP automation systems.

Position Qualifications:

Education Minimum Requirement:

• Bachelor's degree in Automation, Engineering, Science, or Computer-Programming related degree with minimum of 10 years relevant experience

Required Experience and Skills:

• Pharmaceutical Operations process automation experience in a GMP Pilot Plant, Manufacturing or related environment.
• General Power Plant and/or related utilities automation experience.
• Minimum of 3 years experience as a People Manager, skilled in recruiting, developing, mentoring, and retaining talent.
• Strong Capital Project Management skills with ability to manage a portfolio of automation projects and deliver results across multiple priorities, end to end (project inception through design, CQV and operationalization).
• Excellent leadership and influence skills including business case development, facilitative leadership and collaboration, interpersonal and conflict resolution, and oral/written communication skills.
• Strong background in Quality Systems, with ability to develop/manage a suite of Standard Operating Procedures (SOP) and cGMP documents.
• Experience in supporting compliance investigations and change management.
• Familiarity with US and EU GMP and Safety compliance regulations
• Proficient in MS Office Platform and document storage systems

Desired Experience and Skills:

• Experience with DeltaV Live, DeltaV wireless and Charms I/O
• Experience with Potent Compound processing and containment systems (e.g., isolators).
• Experience interacting with or overseeing the management of process utility systems including WFI or PW500 generation/distribution, Process Chillers, Vacuum Systems, etc.
• 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 with coordinating maintenance activities around processing activities to support reliable facility operation.

NOTICEFORINTERNALAPPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

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Expected salary range:

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Employee Status:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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Hazardous Material(s):

Requisition ID:R286419