US_East | Manufacturing & Process Engineer_L1

" Validation EngineerWork Location: Richmond, VAJob DescriptionThe Validation Engineer is responsible for ensuring that manufacturing systems, processes, and equipment comply with regulatory requirements, internal company standards, and quality specifications. This role ensures that all equipment and production processes consistently deliver high-quality products while adhering to applicable regulations, including FDA and other relevant regulatory authorities.The Validation Engineer role is highly cross-functional, combining engineering expertise with regulatory compliance knowledge. The individual will ensure that all stages of the manufacturing process—from raw material handling to final product packaging—are properly validated for efficiency, safety, and compliance.Key Responsibilities:Ensure all manufacturing equipment (e.g., mixers, conveyors, packaging lines) undergo Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to confirm compliance with operational requirements.Validate manufacturing processes to ensure consistent production of products that meet defined quality standards (e.g., blending, cutting, rolling, packaging).Perform periodic revalidation of equipment and processes when changes occur, such as equipment upgrades, material changes, or regulatory updates.Conduct risk assessments related to equipment, processes, and production areas that may impact product quality, safety, or compliance.Identify risks (e.g., equipment failures or process deviations) and implement Corrective and Preventive Actions (CAPA) to maintain compliance and process integrity.Develop, review, and execute validation protocols for new or modified equipment, systems, and processes in alignment with regulatory and internal requirements.Ensure all validation documentation is accurately maintained, archived, and readily available for audits and regulatory inspections, including reports, test results, and CAPA records.Document and control changes in manufacturing processes and equipment, ensuring proper validation prior to implementation.Provide training to production teams on validated processes, equipment usage, and compliance with regulatory and quality standards.Mandatory Skills & Qualifications:Bachelor's degree in Engineering (Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or related field.3–7 years of experience in Quality, Validation, or a regulated manufacturing environment.Strong understanding of validation methodologies, including IQ/OQ/PQ, risk assessment, and data analysis.Knowledge of FDA regulations, GMP guidelines, and food/consumer industry compliance standards.Experience with Manufacturing Execution Systems (MES) and Enterprise Resource Planning (ERP) systems (preferred).Strong communication skills to collaborate with cross-functional teams, leadership, auditors, and regulators.Ability to lead and coordinate onshore and offshore teams."All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"