Quality Assurance Validation Engineer

MilliporeSigma; Missouri; On-site; USD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Validation Engineer to lead validation activities ensuring compliance with regulatory standards. This role is pivotal in generating validation documentation and collaborating with cross-functional teams to enhance product quality. If you are passionate about quality assurance and eager to drive innovation in a diverse and inclusive environment, this is an exciting opportunity to make a significant impact in the fields of Healthcare and Life Sciences. Join a team that values curiosity and creativity, and help shape the future of science and technology.

Qualifications

• Bachelor's degree in Biology, Chemistry, or related field.
• 1+ year of quality and/or validation experience preferred.

Responsibilities

• Coordinate validation activities for systems and equipment.
• Develop and execute validation protocols ensuring compliance.
• Collaborate with cross-functional teams to improve product quality.

Skills

Quality Assurance

Validation Protocols (IQ, OQ, PQ)

Regulatory Compliance (FDA, ISO, GMP)

Risk Assessment

Data Analysis

Education

Bachelor’s Degree in a scientific discipline

Job description

Join us to apply for the Quality Assurance Validation Engineer role at MilliporeSigma.

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

The Quality Assurance Validation Engineer coordinates validation activities (e.g., IQ, OQ, PQ) for systems, equipment, and processes to ensure compliance with regulatory standards and internal policies. This role involves generation of validation documentation, e.g., protocols and reports, and coordination of validation activities to ensure effective execution. This role will work closely with cross-functional teams to maintain compliance and improve product quality.

Key Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems, ensuring compliance with applicable regulations (e.g., FDA, ISO, GMP).
• Perform risk assessments and develop validation strategies based on those assessments.
• Analyze validation data and generate comprehensive validation reports; identify and resolve deviations during validation activities.
• Maintain accurate and up-to-date validation documentation.
• Collaborate with engineering, manufacturing, and quality assurance teams to ensure successful validation outcomes; provide technical support and training to personnel on validation-related topics.
• Manage and maintain calibrated equipment used in validation activities.
• Stay up-to-date on industry trends and regulatory changes related to validation.
• Participate in internal and external audits.
• Support CAPA (Corrective and Preventive Action) investigations related to validation.
• Actively seek ways to improve validation processes, applying lessons learned to enhance efficiency and compliance in future projects.

Who You Are

Minimum Qualifications:

• Bachelor’s Degree in a scientific or engineering discipline (e.g., Biology, Chemistry, Molecular Biology, Biomedical Engineering, Chemical Engineering, etc.)

Preferred Qualifications:

• 1+ year of quality and/or validation experience

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 mean to us, please visit https://www.emdgroup.com/en/company/press-positions.html