Validation Engineer

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

Validation Engineer will be responsible for managing the technical quality aspects associated with validation and regulatory requirements for the manufacture of clinical and commercial APIs. Areas of emphasis include but are not limited to process (product and cleaning) validation and capability assessments, periodic review of validated systems, trend analysis of facility and utility control data.

This position organizes, manages and interprets data, performs detailed data analysis. Generates PPQ/PV and/or CPV documents (plans, protocols, reports) according to timelines and commitments/Quality Agreements.

Compile and interpret quality data, which includes:

• Process capability studies, trending of system and facility performance and contributing to root cause analysis of deviations.
• Create and execute Qualification/Validation Protocols for manufacturing equipment, facilities, utilities, and manufacturing processes.

Essential Duties and Responsibilities of this position include but are not limited to:

• Acts as a technical liaison, as needed, between product development, manufacturing, external manufacturers & suppliers.
• Assist in determining process capability of new equipment. Assists in ensuring product development activities have all necessary validation support.
• Assist in identifying root causes and coordinate corrective action to quality issues in the facility.
• Assisting in creating process documentation to ensure production processing consistent within validated parameters.
• Singular project management (within the realm of validation Engineering) for smaller scope validation engineering plans.
• Collaborate to develop, maintain, and improve validation master plans, PPQ protocols, CSV protocols, reports, risk assessments, gap analyses, traceability matrices, SOPs, and other validation documents.
• Provide support and expertise to multiple projects.
• Design and execute validation engineering related protocols; and summarize studies to ensure consistency of data and compliance with manufacturer and customer specifications with current Good Manufacturing Practices.
• Evaluate equipment or process problems and design testing to determine possible causes or solutions.
• Issues data, memos, presentations and reports concerning qualification projects or areas of interest.
• Lead projects in cross-functional teams to ensure the overall success of a Validation & Qualification projects. Work with Validation management to provide cross-functional leadership to ensure project goals are met.
• Monitor event trends in order to provide proactive corrections/improvement alternatives to minimize the potential for repeat incidents.
• Perform risk assessments and ensure appropriate test plan development, test execution, data analysis, and report writing.
• Provide input on re-validation, assess risk, develop and/or review validation requirements and design deliverables when the facility undergoes changes.
• Review and approve validation deliverables from vendors or contractors. Author cover/gap protocols for vendor supplied Commissioning & Qualification documents and provide oversight for vendor executed test scripts.
• The Validation Engineer is responsible for the design, schedule, execution, and evaluation of scientifically and statistically sound Qualification/Validation experiments which define and demonstrate that critical Cleaning, Controls, Equipment, Facilities, Processes and Utilities function in a consistent and repeatable manner, and are in compliance with regulatory requirements, product license restrictions, and policies affecting final product integrity.
• Use risk analysis to ensure appropriate parameters are evaluated with the required statistical approach to associated testing for justification and support of critical process parameters and quality attributes.
• Write risk assessments to assess and identify potential risks associated with various manufacturing and facility activities.

Physical Attributes

• Occasional reaching, twisting, bending in the performance of job duties.
• Wear appropriate PPE (personal protective equipment) as required for exposure to pharmaceutical operations (i.e. respirators, over-gowning, gloves, steel toe shoes).

Who You Are 

Minimum Qualifications:

• Bachelor’s degree in Science, or Engineering related field.
• 5+ years’ experience in GMP environment.

Preferred Qualifications

• Oral and written communication skills across diverse levels of the organization
• Strong organization, relationship-building, and leadership skills
• Ability to work independently or as part of a cross-functional team under deadlines and changing priorities
• Strong problem-solving, critical thinking, and math skills
• Ability to perform long-range planning in a team environment
• Ability to collaborate and negotiate successfully in a team environment
• Risk analysis, problem-solving, and troubleshooting skills.
• Proficient knowledge of ALCOA+ and Data Integrity principles.

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