Digital Platform Senior Validation Engineer
Millipore Corporation

Job Info

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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 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. You will also provide expert guidance during regulatory audits and will provide project management support for projects which don't have site specific support systems in place.

• 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.

• Operational Change Control, including 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.

Who You Are:

Minimum Qualifications:

• Bachelor's degree in Chemistry, Computer Science, Engineering or other Life Science discipline.

Or

• High school Diploma or GED with 10+ years of experience in validation.

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.
• Global travel based on the need of project and business.

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!

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 Colorado or New York City, 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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