Validation Engineer II

Posté 30 sept. 2020

Bedford, Massachusetts - United States

Demander un identifiant 210717

Détails

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 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 performance 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. For VAC infrastructure, you support 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. 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 or equivalent, and 4+ years of experience in process development or validation engineering

-OR-

  • M.S. in Engineering or Applied Science or equivalent, and 3+ years of experience in process development or validation engineering
  • 3+ years of experience with process and product/system validations (IQ/OQ/PQ)
  • 2+ years of experience in equipment calibration, troubleshooting and repairs

 

Preferred Qualifications:

  • Experience with FMEA/risk analysis, product failure and root cause analysis 
  • Experience authoring formal protocols and reports utilizing Good Documentation Practices. 
  • Experience with equipment design and development, URS
  • Experience with GAMP, software validation, plastics processing, Capital Upgrades, PLC and controls
  • Working knowledge of quality principles including ISO, Quality Management Systems
  • Knowledge of applicable FDA Regulations, USP requirements, and other regulatory requirements (CB Scheme/ UL testing) for products and systems used in biopharmaceutical manufacturing processes
  • Experienced with Product Development Process (PDP)
  • Experience using statistical tools such as Gage R&R, DOE, capability analysis, and data analysis in Minitab
  • Familiarity with change control methodology
  • Capable in the development and execution of test method validations

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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