Validation Engineer I

Posted 10 Mar 2020

Bedford, Massachusetts - United States

Req Id 204191

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 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, you actively participate on product development teams. Your contribution includes implementation of an efficient and thorough validation test matrix, including development of new test equipment and test methods, which ensures robust product specifications based on product design and intended applications.   Your responsibilities include authoring the validation test protocol,  test execution and authoring the report.  You participate in development of the product design specifications and risks assessments and coordinate testing for shelf life studies. You are responsible for planning, documenting and executing test method validations.  In addition, you collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer applications. You effectively interact with other groups, such as Facilities, Engineering Services, Finance, EHS, R&D, Quality 

Who you are:

 

Minimum Qualifications:

  • Bachelor’s degree in Engineering or Science.
  • 1+ years of experience with FMEA/risk analysis, product failure & root cause analysis 
  • 1+ years of experience with knowledge of process & product/system validations.
  • 1+ year of experience authoring formal protocols and reports utilizing Good documentation Practices. 
     
    Preferred Qualifications:
  • Experience with process & product/system validations
  • Familiarity with equipment development, URS, GAMP, software validation, PLC and controls, plastics processing.
  • Knowledge of applicable FDA Regulations, USP requirements, Regulatory requirements (CB Scheme/ UL testing) for systems used in biopharmaceutical processes.
  • Familiarity with Product Development Process (PDP) and Good Documentation Practices.
  • Working knowledge of equipment design, calibration, troubleshooting, and repair
  • Basic statistical analysis skills using Minitab
  • Familiarity with change control methodology, DOE, and process capability
  • Fundamental understanding of test method development and validation, including GR&R
  • Experience with MilliporeSigma filtration, chromatography and Mobius products
  • Occasional travel to our manufacturing facilities

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.

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