Quality Assurance Validation Engineer

MilliporeSigma; St. Louis (MO); On-site; USD 80,000 - 100,000; 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 involves generating validation documentation, coordinating with cross-functional teams, and improving product quality through effective validation strategies. The ideal candidate will have a Bachelor’s degree in a scientific discipline and experience in quality assurance or validation. Join a dynamic team and contribute to maintaining high standards in product quality and compliance within a collaborative environment.

Qualifications

• Bachelor’s degree in a scientific or engineering discipline required.
• 1+ year quality and/or validation experience preferred.

Responsibilities

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

Skills

Validation Protocol Development

Risk Assessment

Data Analysis

Technical Support

Regulatory Compliance

Education

Bachelor’s Degree in a scientific discipline

Job description

Work Location: St. Louis, Missouri
Shift: No
Department: LS-SC-PMLQD Cell Marque Quality
Recruiter: Ashley Hennessy

This information is for internals only. Please do not share outside of the organization.

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.
• 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.

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 quality and/or validation experience