Validation Engineer III

Posté 18 nov. 2021

Bedford, Massachusetts - United States

Demander un identifiant 232184

Détails

 

A career with MilliporeSigma is an ongoing journey of discovery: our 58,000 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.

 

 

US employees must be fully vaccinated against COVID-19 prior to your start date unless an accommodation is granted by The Company. The Company uses the definition of fully vaccinated assigned by the Centers for Disease Control & Prevention for purposes of considering satisfaction of this requirement which is a condition of employment.

 


Your Role:

At MilliporeSigma, the Validation Engineer III participates in product development including implementation of an efficient and thorough validation strategy, development of new test equipment and test methods, which ensures robust product specifications based on product design and intended applications.  

 

  • Author validation protocol, test execution, and reports. 
  • Participate in the development of product design specifications and risk assessments.
  • Coordinate testing for shelf-life studies.
  • Plan, document, and execute test method validations. 
  • Collaborate with Operations, Product Management, and Field Marketing to aid in product/process change requests, raw material qualifications, and customer application inquiries.
  • Work cross-functionally with Facilities, Engineering Services, Finance, EHS and Quality teams.
  • Travel Domestically up to 10%

 

 

Who You Are:

 

Basic Qualifications:

 

  • Bachelor’s Degree in Engineering, Chemistry, Biology, or related discipline AND 7+ years’ experience in process development / validation

 

 OR Master’s degree in Engineering, Chemistry, Biology, or other related discipline AND 5+ years’ experience in process development / validation

 

  • 5+ years of experience with FMEA/risk analysis, product failure, and root cause analysis 
  • 5+ years of experience with process, product/system validations
  • 5+ years of experience authoring formal protocols and reports utilizing Good Documentation Practices

 

Preferred Qualifications:

 

  • 3+ years of experience in the development and execution of the test method validations
  • Experience leading/ supervising a team
  • Experience with product development process and working on cross functional teams
  • Experience using statistical tools such as, capability analysis, Gage R&R’s, data in Minitab
  • Experience with equipment development, URS, GAMP, software validation, PLC and controls, plastics processing
  • Working knowledge of quality principles including ISO, Quality Management Systems
  • Knowledge of applicable FDA Regulations, USP requirements, regulatory requirements (CB Scheme/ UL testing) for systems used in biopharmaceutical processes.
  • Proficient in equipment calibration, trouble shooting and repairs
  • Experience with Millipore Sigma filtration, and Mobius products preferred
  • Experience with change control methodology
  • Working knowledge of EHS guidelines and ergonomics principles
  • ASQ – CQE Certification

 

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!

Our Benefits - http://jobs.vibrantm.com/emd/content/Benefits-at-a-Glance/?locale=en_US

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

If you are a resident of a Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.

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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