Digital Platform Senior Validation Engineer

Posted 21 Dec 2023

St. Louis, Missouri - United States

Req Id 270571

 

Work Your Magic with us!  Start your next chapter and join MilliporeSigma. 

 

Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.  

 

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

 


Your Role:

At MilliporeSigma, the Digital Platform Senior Validation Engineer is responsible for the guidance and direction of validation projects covering all the Life Science digital products, applications, and computerized systems.  You will provide expert guidance on all aspects of computerized systems validation, quality governance and will need to travel to directly assist individuals/site requiring specific support for a limited time during regulatory inspections and/or large projects. You will review and become an expert in the regulatory guidelines as well as being current on potential changes which may impact the validation requirements. 

Responsibilities will include working within the following categories:

  • Computerized systems / digital products/ Control Systems/ Software / OT (Operational Technology - industrial software) / Cloud based solutions, IT Validation (IQ,OQ,PQ, Test Scripts, Protocols, Infrastructure qualification protocols, back-up restoration testing, audit trail testing) / quality assurance, Validation Master Plan meeting GAMP, QMS (Quality Management Systems), P/D-DP (Product/Digital Development Process) and regulatory requirements based on the systems need/scope of target market and internal/external use in GMP and Non-GMP area.
  • Perform 21 CFR Part 11, Annex 11, Risk Assessments, Functional risk assessments, Data Integrity Assessments, FMEA to ensure the requirements, controls are captured prior to development and ensure tested system/products met those requirements. Including ability to review URS, Functional Spec, Design Spec, Test Scripts, User Manual for computerized systems, digital products, software applications (for both COTS and new products/solutions for target markets). 
  • Develop Test Summary Report, Traceability Matrix, Validation Summary Reports, 21 CFR Part 11 / QMS/ Data Integrity White papers, IQ, OQ Protocols, FAT and management of deviation and observation.
  • Leading the Operational Change Control, deviation/CAPA management, customer complaints handling, periodic review, and re-validation of multiple digital products / software applications. Actively participating as auditee presenting / explaining validation and qualification documents / reports to the regulatory, customer auditors and internal /external auditors.

 

Potential for both local and global travel based on the need of project and business.

 

Who You Are:

Minimum Qualifications:

  • Bachelor’s degree in Chemistry, Chemical, Computer Science, Biomedical, Engineering, or other Life Science discipline
  • 5+ years of software / computerized validation experience
  • 5+ years of experience in handling multiple software validation projects within quality assurance

 

Preferred Qualifications:

  • Good written and verbal skills.
  • Excellent computer skills, i.e., Project Planning, Word, Excel, PowerPoint, SharePoint
  • Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes


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 and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
 
Apply now and become a part of our diverse team!

 

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


US Equal Employment Opportunities

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.

We are committed to an equitable hiring process for candidates from a diverse range of backgrounds. As part of this commitment, applicants with disabilities may be entitled to reasonable accommodations. Please contact USLeavesandAccommodations@milliporesigma.com, if a reasonable accommodation is needed or if you otherwise need assistance to participate in the hiring process.


North America Disclosure

If you are a resident of California, Colorado, New York, or Washington, 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.


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