Sr Validation Engineer

Company DescriptionSARACA is a global engineering R&D services company working across industries like MedTech, Aerospace, Rail, Automotive, Semiconductor, and more. With ISO 13485 certification, SARACA specializes in medical device design and development, supporting all classes of devices with expertise in embedded software, UI/UX, mechanical systems, and product testing. The organization is highly skilled in industry standards such as IEC 62304 and EU MDR, boasting a technically proficient team of over 400 engineers. Headquartered globally, SARACA delivers innovative solutions to complex business challenges for Fortune 500 clients. As an equal-opportunity employer, SARACA fosters an environment of learning and innovation, dedicated to driving customer growth and industry leadership.Role Overview We are seeking a Validation Engineer to ensure that manufacturing systems, processes, and equipment meet regulatory requirements, company standards, and quality specifications. The role involves validating equipment and processes to ensure consistent product quality while maintaining compliance with FDA, GMP, and industry regulations.Key ResponsibilitiesExecute IQ/OQ/PQ validation for manufacturing equipment and systems Validate manufacturing processes (blending, packaging, etc.) to ensure consistency and quality Perform revalidation when changes occur (materials, equipment, regulations) Conduct risk assessments and implement CAPA Develop and execute validation protocols and reports Maintain proper documentation for audits and regulatory inspections Manage change control processes and ensure compliance Provide training to production teams on validated processes Collaborate with cross-functional teams (Quality, Production, Engineering) Required Skills & QualificationsBachelor’s degree in engineering (Mechanical, Chemical, Industrial) or related field 3–7 years of experience in validation / quality / manufacturing Strong knowledge of: IQ/OQ/PQ validation methodologies FDA & GMP regulations Experience with risk assessment and CAPA Familiarity with MES / ERP systems Strong communication and documentation skills Ability to lead and collaborate with onshore/offshore teams Preferred ExperienceFood / Consumer / Pharma manufacturing industry Experience in regulated environments Exposure to audit and compliance processes