Data Integrity Risk Assessments and Validation Support
About The Position
The Validation Specialist plays a critical role in ensuring that manufacturing processes, systems, and equipment meet all regulatory and quality standards before full-scale production. This position is responsible for designing, executing, and documenting validation protocols to confirm that processes consistently produce products that meet predetermined specifications. The specialist collaborates closely with cross-functional teams including quality assurance, engineering, and production to identify areas for process improvement and to implement effective validation strategies. By leveraging expertise in process optimization and digital transformation, the Validation Specialist helps drive efficiency and compliance within the manufacturing environment. Ultimately, this role ensures that all validation activities support the company’s commitment to product quality, safety, and regulatory compliance across the United States manufacturing sites.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
- 3+ years of experience in validation within a manufacturing environment, preferably in regulated industries.
- Strong knowledge of validation principles, regulatory requirements (e.g., FDA, ISO), and quality systems.
- Proven experience in project management and process documentation.
- Excellent communication skills and ability to work collaboratively in cross-functional teams.
Nice To Haves
- Certification in validation or quality assurance (e.g., ASQ Certified Quality Engineer, Certified Validation Professional).
- Experience with digital transformation initiatives and automation tools in manufacturing validation.
- Advanced training in process optimization methodologies such as Lean Six Sigma.
- Familiarity with manufacturing execution systems (MES) and electronic documentation management systems.
- Leadership experience in managing validation teams or projects.
Responsibilities
- Develop, review, and execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for manufacturing equipment and processes.
- Collaborate with engineering, quality assurance, and production teams to identify validation requirements and ensure compliance with industry regulations and company standards.
- Analyze validation data and prepare comprehensive reports documenting results, deviations, and corrective actions.
- Lead continuous process improvement initiatives by identifying inefficiencies and recommending optimized validation approaches leveraging digital tools and automation.
- Manage multiple validation projects simultaneously, ensuring timely completion while maintaining high standards of accuracy and documentation.
- Communicate effectively with stakeholders to provide updates on validation status, risks, and mitigation plans.
- Train and mentor junior staff on validation procedures and best practices to build team capability.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
