What are the responsibilities and job description for the Validation Engineer (IQ/OQ/PQ, FDA & GMP) position at SARACA?
We are currently hiring for a Validation Engineer role for an onsite opportunity in Richmond, VA. Please find the details below:
Role Overview:
We are seeking a detail-oriented Validation Engineer to ensure that manufacturing systems, processes, and equipment meet regulatory requirements, quality standards, and operational specifications. This role focuses on validating end-to-end manufacturing processes to ensure consistent product quality while maintaining compliance with FDA, GMP, and industry regulations.
Role: Validation Engineer
Location: Richmond, VA (Onsite)
Experience: 3 Years
Key Responsibilities:
- Execute IQ/OQ/PQ (Installation, Operational, and Performance Qualification) for manufacturing equipment such as mixers, conveyors, and packaging lines
- Validate manufacturing processes (e.g., blending, cutting, rolling, packaging) to ensure consistent quality output
- Perform revalidation activities when changes occur (materials, equipment, or regulatory updates)
- Conduct risk assessments and implement CAPA (Corrective and Preventive Actions)
- Develop, review, and execute validation protocols and reports
- Maintain accurate and audit-ready validation documentation
- Manage change control processes and ensure proper validation before implementation
- Provide training to production teams on validated systems and compliance standards
- Collaborate with cross-functional teams including Quality, Production, and Engineering
Required Skills & Qualifications:
- Bachelor’s degree in Engineering (Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or related field
- 3–7 years of experience in validation, quality, or manufacturing within a regulated environment
- Strong knowledge of IQ/OQ/PQ methodologies, risk assessment, and validation processes
- In-depth understanding of FDA and GMP regulations (Food/Consumer industry preferred)
- Familiarity with MES and ERP systems
- Strong communication and documentation skills
- Ability to lead and collaborate with cross-functional and distributed teams.