Quality Assurance Validation Engineer

Merck KGaA Darmstadt Germany • Saint Louis, MO

265d

About The Position

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.

Requirements

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

Nice To Haves

• 1+ year quality and/or validation experience

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.
• Ensure adherence to company policies and procedures.
• 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.

What This Job Offers

• Job Type: Full-time
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree