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Validation Engineer II

 

A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science, and electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.

 

Your Role:

As a member of the R&D Validation & Applications Center (VAC) Engineering team, you actively participate on product development teams. Your contribution includes development and implementation of an efficient and thorough validation test strategy which ensures robust product performance specifications based on product design and intended applications.  Your responsibilities include authoring the validation test protocol, managing lab test requests, test execution, and authoring the report.  You participate in process and product development supporting DOE studies and data analyses and creation of the product design specifications and risk assessments.  In addition, you collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer applications. Your role includes hands-on development of new  test methods, test equipment, and measurement systems which are utilized to characterize and validate new products, including troubleshooting, repairs, and identifying and implementing equipment upgrades/new technology and planning, documenting, and executing test method validations. You effectively interact with other groups, such as R&D development teams, Quality, Engineering Services, Facilities, EHS and Finance.

 

 

Who You Are:

Minimum Qualifications:

  • B.S. in Engineering or Applied Science, and 4+ years of experience in product/process development or validation engineering -OR- M.S. in Engineering or Applied Science, and 3+ years of related experience
  • 3+ years of experience with FMEA/risk analysis, product failure and root cause analysis
  • 3+ years of experience with process and product/system validations (IQ/OQ/PQ), authoring formal protocols and reports utilizing Good Documentation Practices
  • 2+ years of experience in the development and execution of test methods and validations
  • 2+ years of experience using statistical tools such as Gage R&R, DOE, Cpk, and data analysis in Minitab or equivalent
  • 2+ year of experience with Product Development Process (PDP) or working on cross functional teams

 

 Preferred Qualifications:

  • Experience in equipment calibration, troubleshooting and repairs
  • Experience with equipment design and development, URS, FAT/SAT
  • Experience with plastics processing, capital upgrades
  • Working knowledge of quality principles including ISO, Quality Management Systems
  • Knowledge of applicable FDA Regulations, USP requirements, and other regulatory requirements for products used in biopharmaceutical manufacturing processes
  • Experience with MilliporeSigma filtration products, especially TFF, as well as chromatography and Mobius products
  • Familiarity with change control methodology

RSRMS

 

 

 

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

 

Curious? Apply and find more information at https://jobs.vibrantm.com


The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

Job Requisition ID:  218038
Location:  Bedford
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Nearest Major Market: Boston

Job Segment: Developer, Product Development, Quality Manager, R&D, Environmental Health & Safety, Technology, Research, Quality, Healthcare

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