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Responsible for leading Process Automation System (PAS) implementation at new Greenfield facility. Work with cross-functional teams on developing system requirements, managing System Integrator project to implement and test, and oversight of all Commissioning and Qualification needs during facility startup. Assist in overall company standards and capital planning around Instrumentation and Controls projects.
Summary of Key Responsibilities
- Lead the planning and execution of Automation systems being implemented at Norton, MA Greenfield facility.
- Develop process and building automation system strategic plans for 3-5 year capital investments, across all sites.
- Provide technical leadership for capital projects, including automation system design, control system hardware, equipment design, control panel design, and instrumentation start-up and troubleshooting
- Develop company automation capabilities, including development of technical standards, guidelines, and procedures in accordance with industry best practices for executing large capital projects
- Support manufacturing operations, including troubleshooting of operational issues in manufacturing, maintenance, validation, or capital projects
- Promote a culture of safe and compliant design and operation Serve as technical process automation leader for large capital projects, interfacing with stakeholders and external consultants / contractors
- Review and critique process and automation system designs and support project lifecycle activities in alignment with an ASTM E2500 model
- Manage all aspects of automation system design and integration, including specification development, integration, and validation
- Lead efforts with manufacturing, process development, facilities, QA, and other stakeholders in developing requirements and recommendations for system implementations and modifications
- Provide oversight of Automation system service providers, contract resources and Instrument/Electrical technicians ensuring safe, compliant maintenance and project execution
- Lead Automation issue identification and resolution, including all compliance aspects such as Deviation investigation, Change Control, Corrective and Preventative Action (CAPA)
- Provide technical support for troubleshooting, improving, or optimizing ongoing manufacturing operations
- Requires a Bachelor’s degree in Electrical or Chemical Engineering or related technical field
- 12+ years of relevant work experience – including design, build, test and ongoing operations support
- Manufacturing experience, including experience managing automation projects and leading automation system design
- Strong understanding of GMPs and good engineering practice (GEP), including ISA S88, GAMP, ASTM E2500, ISPE guidance, etc.
- Experience developing and executing bid activities such as requests for proposals, including scope of work identification, technical bid package development, bid evaluation and selection
- Direct experience with good engineering practices, specifically in regulated environments (i.e. cGMP, OSHA, EPA). Detailed understanding of cGMP processes; commissioning and qualification, validation, change control preferred
- Ability to evaluate automation systems from a compliance perspective and ensure adherence to applicable standards (i.e. 21CFR Part 11, EU Annex 11)
- Demonstrated experience working with Rockwell Automation (PlantPAx) and Control Logix PLCs in project execution and lifecycle management
- Familiarity with virtual infrastructure using VMware and understanding the integration between virtual and physical systems
- Carry a mobile phone/ device
- Valid driver’s license
- Ability to provide rotating 24x7 on-call technical support of Automation systems for ongoing operations
- Ability to lift 50 lbs.
- Ability to travel up to 15%