Validation Engineer II

Posted 20 Sep 2019

Bedford, Massachusetts - United States

Req Id 197683



A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. 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 with MilliporeSigma you will actively participate on product development teams to understand the new product and its applications and implement an efficient and thorough validation test matrix including development of new test equipment and test methods. You will be responsible for authoring the validation test protocol, coordinating test execution and authoring the report.  You will participate in development of the product design specifications and risks assessments. You will also develop the test matrix and coordinate testing for shelf life studies. In addition, you will provide validation engineering support to Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer applications.


Who You Are:

Minimum Qualifications:

  • Bachelor’s degree in Engineering, Applied Science or related Science or Engineering degree with 3+ years’ experience in validation engineering or a Master’s degree in Engineering, Applied Science or other related Science or Engineering discipline. 
  • 3+ years’ experience using statistical analysis tools such as Gage R&R, DOE, capability analysis, and data analysis in Minitab. 


Preferred Qualifications:

  • Bachelor’s degree in Engineering or Applied Science with 5+ years of experience in a related technical area or Master’s degree with 3+ years’ experience.
  • Understanding of quality principles including ISO, Quality Management Systems, Good Documentation Practices and tools including FMEA, risk analysis and root cause analysis.
  • Experience with Product Development Process (PDP).
  • Experience with product/process/software/automated system validation. 
  • Familiarity with MilliporeSigma Chromatography, NFF, TFF, or Mobius disposable products and systems
  • Knowledge of applicable FDA Regulations and regulatory requirements for products used in biopharmaceutical processes.
  • Familiarity with change control methodology.
  • Self-motivated, enthusiastic and able to interact effectively with people in all areas of the company including Plant Operations, R&D, Quality, and Product Management.
  • Excellent written and verbal skills in English.


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

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.

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