The Senior Staff Engineer, Automation will be a member of the Biologics Network team. The Senior Staff Engineer 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 Senior Staff Engineer will provideautomation technicalleadership, guidance, and support to the operations teams at each Biologic site as needed andwillpartner with the various functions to develop automation technical roadmaps and capitalinvestmentstrategies. The Senior Staff Engineer will be responsible for developing, deploying, and maintaining the Good Engineering Practices (GEP) program in the Biologics Network and the creation of automation related technical engineering standards. (S)he will create and maintain relationships with other Thermofisher 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. The position is remote, but can be located in St. Louis, MO.Global travel expectations up to 50% within multiple countries.

Essential Functions:

• Leads biologics network automation systems strategy and roadmap
• Works with site automation leads to develop project roadmaps that feed into greater network roadmap.
• Leads combination of 3rd party teams and site teams to develop project scope, schedule and costs.
• Manages 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)
• Understands and analyzes site and business unit requests for viability and presents optionality to meet needs
• Works with site general managers, VP of Operations and business unit leads to understand needs, build roadmap and reguarly communicates progress associated with on-going efforts
• Interfaces with other parts of the organization to harmonize efforts with the grearter Thermofisher network
• Understands technical layout of each facility and challenges associated automation in a high change-over and flexible manufacturing facility
• Understands processes and major stakeholders at each site
• Leads global projects and, in some cases, site projects that are intended to operate as a “pilot project” for rest of network.
• Supports and works 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.
• Works in a safe and responsible manner and obey all safety policies and procedures.
• Complies with all job-related safety and other training requirements.
• Performs other duties as assigned.

Qualifications:

• Minimum of 15 years of experience in the biotech engineering/manufacturing environment or closely related field
• Bachelor of Science degree in Chemical, Electrical or Mechanical Engineering or related engineering 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
• Experienced in an FDA regulated environment
• Capability to evaluate, define requirements and set technical direction for automation systems across global network of facilities.
• Experience with systems such as OSI PI, Infobatch and AlarmWorX, ESXi, Syncade, Pharmasuite installation and support
• Experience with DCS and/or PLC coding including but not limited to DeltaV, Allen Bradley, Siemens.
• Understanding of electrical standards and local requirements and general electrical safety best practices
• 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 in implementing MES functionality related to bio-manufacturing facility
• Understanding of bridge between typical business / quality IT systems and manufacturing automation systems (ERP, LIMS, QMS, etc)
• Understanding of P&ID loop tuning fundamentals
• 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 thermofisher expert network.
• Proficient in standard MS tools and software required to execute job requirements (AutoCAD, etc).
• 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
• Experience with automation network infrastructure strongly desired
• Experience with building automation systems
• Strong ability to work independently
• Comfortable supporting multiple concurrent issues