24 days old

Engineer II Automation Lab Support-Lexington

Patheon
Massachusetts Gore, ME 04936
107461BR
Location :
US - Massachusetts - Lexington
:
Job Description
Thermo Fisher Scientific is a dynamic gene and cell therapy contract development and manufacturing organization that is looking for leaders to bring the highest quality processes, products and testing to our clients.

Our staff members are committed to making a difference in our organization, for our client partners and the patients we serve. We seek individuals with proven competencies and strong character to help lead our organization now and into the future.

Specific Responsibilities: Manage and support computerized Lab Systems.Develop lab systems roadmap for Thermo Fisher Scientific Operations; accounting for current and future business needs and make technology decisions. Collaborate with IS Architects, Infrastructure Leads and Business Analysts to develop roadmaps supporting organizational priorities and platform improvementsProvide vision and lead implementation of digital lab initiatives providing experiment design, authoring, and execution solutionsWork with multi-functional representatives across Process Development, Quality Control, and sites to align business processes with technology capabilitiesLead vendors and contractors providing guidance as necessary to ensure the delivery of workLead key strategic supplier relationships from both product and services side, as required.Ensure compliance with Thermo Fisher Scientific and industry practices policies, procedures, legal requirements and goals of project sponsors. 5+ years of biopharma experience in operations/manufacturing /lab operations/IS, including cGMP regulated environmentsExperience configuring domain controllers and active directory serversGood overall understanding of business, manufacturing, and laboratory systems common in the process manufacturing as well as the integration of these systems through applicable standardsSolid depth or breadth of expertise with offerings within the Lab solution landscape – including ELN, inventory management, MES and scientific analysis tools. Up-to-date knowledge of lab vendor’s software strategy and available competing solutionsDemonstrated ability to find opportunities and implement new technologies and services to transform the business into a more agile, efficient and effective organizationKnowledge of enterprise software and cloud architecture and structure of software solutionsExperience configuring network routers, switches, and routers (Cisco)Ability to deal with complexity and ambiguity, see the big picture, and drive enable relevant business analyses and facilitate decision-makingGreat teammate who can collaborate and provide leadership through influence to achieve the required resultsExcellent verbal, written, and communication skills, including the ability to set the context and present on complex subjects to senior management in clear and concise mannerUnderstanding of FDA regulations governing computer system validation. Demonstrated working knowledge on automation systems and manufacturing information systems in regulated environments, FDA cGxP and 21 CFR Part 11 regulations, software development lifecycle and system validationERP and LIMS experience are a plus.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.


If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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Posted: 2019-11-13 Expires: 2019-12-13

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Engineer II Automation Lab Support-Lexington

Patheon
Massachusetts Gore, ME 04936

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