Senior Validation Quality Engineer

Posted 12 Feb 2024

Danvers, Massachusetts - United States

Req Id 271992

Work Your Magic with us!

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.


Your Role:

 

You will be in responsible for developing and executing equipment and process validation projects with a quality focus and risk based approach. You will interact on a daily basis and develop strong relationships with Operations, Quality, Process Engineering, Planning, and other key internal/external stakeholders ( R&D, Supply Chain, etc.)

Responsible for design transfer validation of New Product Introduction (NPI) to manufacturing at MilliporeSigma Danvers, MA site.

 

This will be a hybrid role and it will be necessary to live within a reasonable commute of our site in Danvers, MA.

 

Primary Responsibilities:

  • Generate and execute validation protocols (Feasibility, OQ, PQ, PPQ) for various raw materials, fixtures and equipment’s. 
  • Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls for product validation, process validation, and applicable validation activities.
  • Perform and facilitate raw material change and new equipment risk assessments.
  • Manage project schedules with strict adherence to critical milestones to ensure quality and security of supply to EMD Millipore customers 
  • Coach and mentor new and junior members of the team.
  • Lead all validation involving design transfer of New Product Introduction
  • Lead in building quality related infrastructure, & instruments including preparation of URS, System Risk Assessment, and subsequent validation
  • Lead in troubleshooting.
  • Proactively identifying risks and opportunities through a variety of surveillance activities including trending of non-conformance events
  • Lead in implementing change and improvement solutions across cross- functional teams
  • Lead product risk assessment activities through application of a working knowledge of applicable standards and tools such as (application, design, process) FMEAs and FTA.
  • Lead by addressing lessons learned and reviewing complaint data in support of development, modification and improvement of design processes and quality management system
  • Lead process validation by generating Validation Master Plan (VMP), IQ, OQ and PQ protocols and reports.
  • Perform and facilitate raw material change and new equipment risk assessments and validation.
  • Develop validation strategy, protocols, and reports with a risk-based approach in alignment with the established critical process controls (CTQ, CQA, CPP) for product validation, process validation, and applicable validation activities.
  • Review the Change Control system to determine the impact of proposed changes to the qualification status of equipment and processes.
  • Generate CTQ monitoring data for equipment and processes.
  • Lead in troubleshooting and Root Cause Analysis (RCA)

 

Who you are:

 

Minimum Qualifications:

  • 5+ years validation experience handling of multiple projects within the biopharma, biotech or medical device industries.
  • Minimum B.S. degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Chemical Engineering, Biochemistry or equivalent
  • Full understanding of product, equipment and process validation
  • Demonstrated capability of applying risk management concepts and tools
  • Hands-on experience in troubleshooting and the application of quality system standards
  • Experienced at working in cross-functional teams
  • Strong written and verbal communication skills (internal/external)
  • Strong teamwork and collaboration skills
  • Experience with GMPs, GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems in support of validation of processes
  • Experienced with Quality & GxP IT compliance requirements

 

Preferred Qualifications:

    • ASQ Quality Engineer Certification (CQE)
    • Six Sigma Certification
    • Quality by Design
    • Applied/industrial statistics experience
    • Detailed Knowledge of GMP, ISO and FDA design and development quality requirements
    • Knowledge of aseptic processing

 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 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.

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