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.  

 

Your role:

 

In the role of Validation Engineer, I – Process Validation, you will be reporting to the Head of MSAT. The Validation Engineer I position is responsible for developing, reviewing, and managing the execution of validation activities. In this role you will provide technical leadership within cross-functional teams with primary responsibility as subject matter expert in the strategy for process validation of unit operations within Bioconjugation and Bio Organics facilities. Job duties and tasks include:   

 

Define and implement process validation framework.  Implement consistent process qualification, process validation and continuous process verification (CPV) strategies. Define strategy for execution of process performance qualification (PPQ) and product life cycle. Generate, review, and approve process validation protocols and reports. Lead development of studies around process hold time, homogeneity, mixing etc. Lead establishment of drug substance/API manufacturing process control strategies and assess process performance by monitoring and analyzing process/product data. Lead process validation related investigations. Work closely with the client and personnel from Manufacturing, Process Development, Process Sciences, Quality Control, Quality Assurance, Operations, and Project Management to ensure the scientific and CMC strategies are robust and maintained. Maintain compliance with applicable regulatory requirements.  Data Management, Generation of Process Validation/CPV documents.  Organizes, manages, and interprets data, performs detailed data analysis.   Process Validation SME in audits and customer meetings as needed. Self-starter with ability to manage workload with minimal supervision. Ability to drive projects forward with collaboration and making sound decisions.

 

Who You Are:

 

Minimum Qualifications:

 

Bachelor’s Degree in Engineering (Chemical Engineering, Mechanical Engineering, etc.) or Life Science (Chemistry, Biology, etc.)1+ years of experience in Validation or 1+ year of experience in a GMP Environment.

 

Preferred Qualifications:

2+ years of experience/ SME level of understanding with manufacturing, process validation, Process Performance Qualification (PPQ) and Continued Process Verification (CPV)Ability to utilize GDP during document creation and reviewComfortable in a fast-paced environment with the ability to adjust to changing priorities.Flexibility and accountability Experience working with current regulatory guidelines and standards.  Experience working with pharmaceutical standards, rules, and guidance (e.g., FDA, EU, ISO, ISPE, etc.) 

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