Engineer - Global Integrity Testing
Gaithersburg, MD 
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Job Description

Position description

If you want to reshape the world and discover your greatest potential, Saint-Gobain provides one-of-a-kind opportunities for innovative problem solvers.


We're one of only two companies in the world that is consistently recognized as both a top Global Employer and a Top 100 Global Innovator, but Saint-Gobain's remarkable story and culture of innovation begins with a team of nearly 200,000 creative, diverse and passionate team members collaborating across the globe. We are committed to our mission to improve lives because, every day, we witness the enormous impact of our efforts on the world around us.

The Engineer for the Global Integrity Testing program, will execute design of experiments, test method development, equipment/product/test method validations and technical test method transfers of the pressure hold leak decay test and tracer gas mass spec helium leak test, to support the integrity testing of complex single use assemblies. This role will involve the review of existing designs to develop an appropriate test strategy. The incumbent candidate must be able to systematically assess a design based on engineering drawings, create test drawings, and develop validated test methods for each assembly/class of assemblies.


In a highly agile and empowered environment, this role will drive the technical progress of several integrity test method projects concurrently. Our external and internal customers rely on timely and efficient project planning, execution and status reports to enable BPS to secure future business only guaranteed with the successful and timely implementation of the global integrity testing program.


As the Engineer - Integrity Testing, this role will be responsible for supporting project management by reporting progress and roadblocks, independently developing and maintain subject matter expertise in integrity testing and transferring that knowledge to others.

Essential Functions

  • Integrity Test Method Development, Validation, Analysis of data and Reporting
  • Develop SOPs, Test Methods, and Work Instructions to support the development and technical transfer of the Integrity Testing Program
  • Train and coach others in integrity test methods sharing best practices to establish site specific subject matter experts per site per integrity test method; Supporting, guiding, coaching team members to be successful in leading their assigned tasks
  • New equipment sourcing and qualification
  • Mechanical design/review of designs of restraint systems
REQUIRED QUALIFICATIONS
  • Bachelor's degree in Science or Engineering (Mechanical or similar field and / or Project Management, or Organizational Development & change management.
  • 3 years ofengineering or physical laboratory experience in a regulated industry
  • Knowledge of ISO, GMP, and FDA requirements applicable to validating test equipment and test methods(Required)
  • Proficient computer skills (MS Word, Excel and PowerPoint)(Required)
  • Familiar with single use assembly designs and assembly components(Required)
  • Proficient in interpreting and applying consensus test standards (ASTM, ISO, USP, etc.)(Required)
  • Excellent written and oral communication skills, including technical communication. (Required)
  • Experience with tracer gas leak testing(Preferred)
  • Experience with pressure decay testing (Preferred)
Who are we ?

Saint-Gobain's innovations touch almost every major industry around the world. Within its Life Sciences division, teams are solving critical problems for customers who are getting life-saving medical devices to the frontlines of healthcare, discovering essential medications, and nourishing and connecting the world through consumer, industrial and electronics applications. As one of the world's leading producers of high-performance polymer products, we improve lives by making simple experiences better and being there in life's critical moments.

Our team members recognize that we all create the environment for people to succeed, with a culture built on respect, open and honest communication, and honoring our commitments to our customers and each other. And at the heart of our culture, we've learned working together makes good ideas, great ones.

With a legacy dating back more than 350 years, Saint-Gobain offers employees the stability and security of a leading Global 500 corporation while operating like multiple small and agile start-ups, where entrepreneurial spirit, pioneering teamwork, and bold, forward-thinking ideas pave new paths.

Every team member is encouraged to develop and leverage their unique expertise and strengths to make the greatest impact on the company and our end users. At Saint-Gobain, you're empowered and equipped with countless opportunities and resources for professional development. You will find the support you need to create a vision and roadmap for your career, and make that vision a reality.

Invent yourself at Saint-Gobain Life Sciences; and together, we'll create a better life.

Legal Statement

Saint-Gobain provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Saint-Gobain is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.


Equal Opportunity Employer of Minorities, Females, Protected Veterans, and Individual with Disabilities

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
3+ years
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