Engineer I, Validation

Pharmaceutical Product Development (PPD)

Fremont, California, United States of America

Job Description

The Company 

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $42B and 130,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve sophisticated analytical challenges, improve patient diagnostics and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. 

When your part of the team at Thermo Fisher Scientific, you’ll do important work. And you’ll have the opportunity for continual growth and learning in a culture that empowers your development. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

Our Materials and Structural Analysis business helps customers drive brand-new research and discoveries by delivering innovative microscopy, spectroscopy, and microanalysis solutions, such as world-class scanning and transmission electron microscopes, DualBeam™ FIB-SEMs, and spectrometers, combined with sophisticated software suites. We span across the business areas of spectroscopy, visualization software, semiconductor, life sciences, and material sciences, as well as global support functions, like commercial sales, service, operations, research and development, sophisticated technologies, and marketing.

The Mission 

The Engineering Data Management group (EDM) is responsible for maintaining all user documentation archived within our Product Data Management system, Teamcenter.  We are also responsible for the investigation, execution, and implementation of all Engineering Change Orders (ECO) for our north American sites. Through our lifecycle management process, the EDM group ensures TPD is properly archived in our system and meets all regulatory standards.  This documentation includes CAD Data (NX and SolidWorks), mfg technical specifications, supplier information, item attributes and compliancy information such as RoHS, NFPA79 standards, etc.  Our department is based out of Hillsboro, Oregon, but we support MSD sites in Fremont, CA. Richardson, TX and Tewksbury, MA.  We also have an EDM department in Eindhoven, NL and in BRNO, CZ, whom we collaborate with daily.

The Position   

The Validation Engineer I position is responsible for reviewing and releasing all technical engineering documentation into our PDM system, for R&D and Operations.  This position will also support Engineering Changes for our north American sites by communicating with R&D Engineers, Engineering Change Coordinators, and various departments within the organization.  You are also responsible for supporting generating new documentation and following archiving and change control procedures for all MSD engineering data. The position collaborates closely with the Engineering department, Product Lifecycle Manager (PLM), R&D, Manufacturing, Logistics, Purchasing, Quality and Technical Service Support (TSS) groups within Thermo Fisher Scientific and suppliers to archive and maintain engineering data throughout the product lifecycle.  The position is based at our Fremont, CA site and is expected to be onsite at least 4 days a week.

Specific work associated with this position include: 

  • Ensuring quality TPD in our PDM system
  • Generating and maintaining CAD data, new part numbers, new revisions, user documentation, bills of material, compliance certificates, etc.
  • Training engineers and other various departments in our data management requirements and processes.
  • Supports Change Leaders by completing ECO investigations and execution steps.
  • Supports MSD Global Operations & Global Service with product issues and/or ECO implementation as necessary.  
  • Ensures that ECO process WIP, cycle time and other targets are being met within their scope of activity. 
  • Develops close relationships with Engineering, Logistics, Service, and Quality to adequately resolve technical conflicts. 
  • May act as an advisor to peers and project resources to resolve user documentation problems.  
  • May participate on Change Review Boards review of implementation plans for engineering changes to ensure plans have a positive value and minimum disruption to Factories and Service. 
  • Meet all work safety, fire safety, hygiene of work and other regulatory standards. Clean and maintain work area and consigned tools 
  • Other duties as assigned 

The Requirements   

The successful candidate will possess the following combination of education and experience: 

  • BS/AA Degree in Mechanical Engineer and Combination of education and experience that demonstrates the required skills. 
  • 2+ years of experience with Document Control tools (e.g. Teamcenter).
  • 2+ years CAD experience required.
  • Ability to coordinate and lead small project teams.
  • Ability to plan and resolve issues that involve gaining agreement of multi-functional, multi-cultural groups and sites without damaging relationships.   
  • Must demonstrate ability to create user documentation using common Microsoft Office and Acrobat applications.
  • Must be able to be onsite 4 days a week
  • Proven track record to analyze data and implement basic problem solving. 
  • Must have ability to obtain a valid passport and travel regionally and internationally (0% - 10% of working time) 
  • Fluency in English and local language (verbal and in writing)  
  • Must demonstrate excellent written and verbal communication skills 

Knowledge, Skills, Abilities

  • Attention to detail
  • Digital literacy
  • Customer focus
  • Strong communicative and multicultural interaction skills 
  • Planning / Organizing, Prioritizing & Goal setting
  • Focus on Quality and sustainability
  • Detailed problem solving
  • Holistic thinking
  • Independent Decision Making 
  • Creativity and Innovation

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve sophisticated scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today!http://jobs.thermofisher.com

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

•    This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.

Compensation and Benefits

The hourly pay range estimated for this position based in California is $28.00–$37.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs

  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement

  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

  • Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Job posted: 2024-04-26

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