Digital Automation Engineering Programs Lead
About the Job
Location/Division Specific Information
Greater Boston Area – The position is based in Cambridge, MA, but time may be spent at other local VVS facilities and up to 20% travel to the Alachua, FL facility and other local facilities.
How will you make an impact?
The Digital Programs Lead will be a member of the VVS Global Engineering team. The Digital Programs Lead is responsible for providing advanced level expertise to global automation projects including feasibility & concept studies, capital facility buildouts and equipment purchases, facility master plans, process improvement projects, etc. He/she may serve as the overall project lead or project technical lead. The role requires the ability to manage multiple contractors and a portfolio of technical projects at the same time. The Digital Programs Lead will provide automation engineering technical leadership, guidance, and support to the operations teams at each VVS site as needed and will partner with the various functions to develop automation and digital systems technical roadmaps and capital investment strategies. The Digital Programs Lead will be responsible for developing, deploying, and maintaining the Good Engineering Practices (GEP) program in the VVS Network and the creation of automation related technical engineering standards. (S)he will create and maintain relationships with other Thermo Fisher network resources to develop and promote engineering best practices and ensures compliance with SOP's, safe work practices, and cGMP regulations. The position involves close collaboration with Manufacturing, Manufacturing Sciences, Quality Assurance, Quality Control, and Global and Site Engineering teams to complete all responsibilities.
What will you do?
- Drive VVS network automation systems strategy and roadmap towards Pharma 4.0 vision.
- Work with site automation and operations leads to develop project roadmaps that feed into greater network roadmap.
- Serve as the system owner for select global automation and operational technology systems.
- Lead combination of 3rd party teams and site teams to develop project scope, schedule and costs.
- Manage network wide automation projects including but not limited to – manufacturing infrastructure evaluation and upgrades, data connectivity projects, MES layer implementation, connectivity between MFG network systems and business/quality IT systems (LIMS, ERP, etc).
- Understand and analyze site and business unit requests for viability and present optionality to meet needs.
- Work with site engineering and manufacturing teams, site general managers, and business unit leaders to understand needs, build roadmap and regularly communicate progress associated with on-going efforts.
- Interface with other parts of the organization to harmonize efforts with the greater Thermo Fisher network.
- Understand technical layout of each facility and challenges associated automation in a high change-over and flexible manufacturing facility
- Understand processes and major stakeholders at each site
- Lead global projects and, in some cases, site projects that are intended to operate as a “pilot project” for rest of network.
- Support and work with local and corporate IT teams to ensure interfaces between IT and OT systems are smooth and that any OT systems meet general security and set-up requirements by IT team.
- Perform other duties as assigned.
How will you get here?
A B.S. degree in computer sciences, electrical engineering, automation engineering, mechanical engineering, chemical engineering, or related engineering field
- Minimum of 15 years of experience in the biotech engineering/manufacturing environment or closely related field
- Experience with executing cGMP facility construction, process equipment, utilities, and automation projects and/or supporting these areas in an operating biomanufacturing facility
- Working knowledge of cGMP, OSHA, NEC and EPA regulations
- Experience in an FDA regulated environment
- Capability to evaluate, define requirements and set technical direction for automation systems across network of facilities.
- Experience with systems such as OSI PI, Infobatch and AlarmWorX, ESXi, Pharmasuite installation and support
- Experience with DCS and/or PLC coding including but not limited to DeltaV, Allen Bradley, Siemens.
- Experience with automation network infrastructure
- Experience with building automation systems
- Understanding of electrical standards and local requirements and general electrical safety best practices
- Strong understanding in implementing, operating and maintaining MES functionality related to bio-manufacturing facility, MES project experience strongly desired.
- Understanding of "smart" instrumentation protocols (i.e.: HART, Fieldbus, PROFIBUS, AMS Suite, etc.)
- Understanding of automation hardware (system l/0 modules &/or cards, power supplies, control relays, signal conditioners, etc.)
- Strong understanding of industry standards for commissioning, validation, and lifecycle management of automation systems
- Understanding of bridge between typical business / quality IT systems and manufacturing automation systems (ERP, LIMS, QMS, etc)
- In depth understanding of general cGMP standards and practices
- Strong interpersonal and communications skills; written and oral
- Ability to work effectively with both local and remote teams in a matrix environment
- Ability to travel to multiple global sites to support the biologics network and general Thermo Fisher expert network.
- Proficient in standard MS tools and software required to execute job requirements.
- Strong understanding of applicable regulatory requirements. Audit experience is preferred.
- Strong technical documentation review and revision experience
- Experience with people and project management
- Experience with single-use bio-manufacturing technologies and automation strongly desired
- Strong ability to work independently
- Comfortable supporting multiple concurrent issues