Quality Assurance Validation Engineer

Merck Gruppe; St. Louis (MO); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Validation Engineer to coordinate validation activities for systems and processes. This role is crucial in ensuring compliance with regulatory standards and internal policies. You will be responsible for developing validation protocols, performing risk assessments, and collaborating with various teams to enhance product quality. If you have a passion for quality assurance and a background in scientific or engineering disciplines, this opportunity will allow you to make a significant impact in a dynamic environment focused on continuous improvement and compliance.

Qualifications

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

Responsibilities

• Develop and execute validation protocols ensuring regulatory compliance.
• Collaborate with cross-functional teams to improve product quality.
• Analyze validation data and generate comprehensive reports.

Skills

Quality Assurance

Validation Protocols (IQ, OQ, PQ)

Regulatory Compliance (FDA, ISO, GMP)

Risk Assessment

Data Analysis

Education

Bachelor’s Degree in a scientific or engineering 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:

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

Who You Are:

Minimum Qualifications:

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

Preferred Qualifications:

1. 1+ year quality and/or validation experience

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.