Quality Validation Engineer

Posté 08 juil. 2022

St. Louis, Missouri - United States

Demander un identifiant 251757

Détails

 

A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 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.

 

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.


Your Role:

At MilliporeSigma, the Quality Validation Engineer is recognized as a strong quality presence and technical resource. The Engineer is responsible for developing, reviewing, and managing the execution of validation activities, and ensuring that the qualifications are consistent with the user’s/manufacturer’s requirements and quality standards.

 

  • Interact cross-functionally with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance
  • Oversee and perform computer systems validation activities for automated equipment and analytical equipment per requirements.
  • Provide input on improvement of testing documentation.
  • Utilize GDP in a GMP atmosphere while generating protocols and reviewing documents. 
  • Review and generate closing reports for executed protocols.
  • Work through a Management of Change system to determine the impact of proposed changes to the qualification status of equipment, software, or facilities.
  • Identify and establish revalidation requirements.
  • Write and execute qualification packages, technical reports, and validation master plans.

 

Who you are:

 

Minimum Qualifications:

  • Bachelor’s Degree in Computer Science, Biomedical Engineering, Chemical Engineering, Chemistry, Biochemistry or other life science discipline

 

 Preferred Qualifications:

  • Ability to apply and incorporate regulatory standards, rules, and guidance. (e.g. FDA, EU, ISO, ISPE, etc.)
  • Comfortable in a fast-paced environment with the ability to adjust to changing priorities
  • Detailed-oriented work standards
  • Sound understanding of Quality Risk Management concepts

RSRMS


 

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!

 

Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com

 

If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html

 

If you are a resident of NYC, 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.

 

As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.

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