Quality Engineer

Posted 22 Nov 2019

Wilbraham, Massachusetts - United States

Req Id 200566


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.

The Cell Therapy Processing team is developing novel technologies to enable cell and gene therapy processes. The technologies comprise of patented acousto-fluidics platforms to manipulate cell processes, such as concentration, washing, differentiation, sorting, and culturing.


Your role: 

We are in search of candidates with experience in validation planning of automated laboratory equipment and/or single-use disposables and materials.  Your role in validation planning will include the creation of validation methods and test procedures, preparation of test setups, coordination with suppliers, collection of data, and documentation of results for reporting.  Your role will involve frequent interfacing with testing laboratories, manufacturing suppliers, external development partners and internal stakeholders.  Travel to internal and external sites will be required as needed to communicate and perform these duties.  As part of the product development team, your role will also require close coordination with our R&D team to smoothly transition advances in technology into future products by participating in the creation of user requirement specifications and test, development and validation plans for these products as well.


Who you are:

Minimum Qualifications:

  • Bachelor's degree in Biomedical Engineering degree or related field with 3+ years of hands on experience in product development of biomedical devices or process equipment or instrumentation working within a core team structure.
  • Experience with engineering change control processes and managing dynamic product designs in the transition to validated manufacturing
  • Proven experience in process validation and developing, writing and executing qualification test procedures including design, implementation and documentation of test programs
  • Customer-facing experience in your previous roles
  • Experience interfacing with vendors and developing qualified supply chains
  • Experience in the qualification and validation of engineering systems (IQ, OQ, PQ)


Preferred Qualifications:

  • Master's degree in Biomedical Engineering or related field
  • Medical device or other safety critical device development including specific requirements of GMPs, GAMP5, FDA QSR and ISO 9001 standards

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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