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:

In this role, you will be the Digital Platform Senior Validation Engineer. This position is responsible for the guidance and direction of validation projects covering all the Life Science digital products, applications, and computerized systems.  Your primary focus will be creating automated devices and instrumentation that facilitate chemical synthesis and sample preparation, ensuring these systems are robust, precise and scalable.

Responsibilities include but not limited to:

Reviews regulatory requirements based on the systems need and scope of target market and internal and external use in GMP and Non-GMP areas.Performs 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. Develops Test Summary Report, Traceability Matrix, Validation Summary Reports, QMS, Data Integrity White papers, IQ, OQ Protocols, FAT and management of deviation and observation.Leads the Operational Change Control, deviation, CAPA management, customer complaints handling, periodic review, and re-validation of multiple digital products and software applications. Actively participating as auditee presenting and explaining validation and qualification documents or reports to the regulatory, customer auditors and internal and external auditors.

Who You Are: 

Minimum Qualifications:

Bachelor’s degree in Life Science (Chemistry, Biology etc) or  Engineering, (Chemical, Mechanical etc) or Computer Science. 5+ years software  or computerized validation experience. 

Preferred Qualifications:

Experience with Project Planning, Word, Excel, PowerPoint and 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