Qualification/Validation Engineer

Company DescriptionSARACA is a global engineering R&D services company providing innovative solutions to industries such as MedTech, Aerospace, Rail, Automotive, Semiconductor, and Defense. With ISO 13485 certification, the company specializes in the design and development of next-generation medical devices, offering expertise in embedded software, UI/UX, mechanical systems, and product testing. SARACA has unique expertise in compliance with global standards such as IEC 62304 and EU MDR, as well as a strong reputation for scientific writings in MedTech. Supported by a team of over 400 technically skilled engineers and consultants, SARACA delivers exceptional results across onsite and offsite projects worldwide. Committed to fostering innovation and professional growth, SARACA is an equal-opportunity employer with a focus on helping customers achieve business success.Key Responsibilities:Perform equipment and HVAC qualification activities as per SOPsDevelop and execute IQ/OQ/PQ protocolsConduct testing to ensure equipment performance under defined conditionsDocument test results, deviations, and corrective actionsEnsure compliance with FDA and cGMP regulationsMaintain accurate and audit-ready qualification documentationCollaborate with internal teams and external contractors Mandatory Skills:Bachelor’s degree in Engineering / Life Sciences / related field3–5 years of experience in equipment qualification & HVAC validationStrong knowledge of IQ/OQ/PQ processesExperience with cGMP and FDA regulatory standardsStrong analytical, problem-solving, and documentation skillsProficiency in data analysis and reporting toolsAbility to work in cross-functional teams 📩 Interested candidates, please share your updated resume at:akshat.gaur@saracasolutions.com or connect with me here on LinkedIn. #Hiring #ValidationEngineer #QualificationEngineer #IQOQPQ #cGMP #FDA #PharmaJobs #EngineeringJobs #PhoenixJobs #Capgemini #OpenToWork