Validation Engineer

Company DescriptionSARACA is a global engineering R&D services company serving 25+ Fortune 500 customers across diverse industries such as MedTech, Aerospace, Automotive, and Defense. As an ISO 13485 certified design and development organization, SARACA specializes in medical devices, offering expertise in embedded software, UI/UX, mechanical systems, and product testing. With over 400 engineers and management consultants worldwide, SARACA solves complex business challenges through innovation and technical excellence. The company prides itself on a culture of learning and growth while helping clients excel in their industries. SARACA is committed to fostering an inclusive and equal-opportunity work environment.Role DescriptionThis is a full-time, on-site role for a Validation Engineer located in Phoenix, AZ. The Validation Engineer will be responsible for ensuring reliable and high-quality systems through validation processes, including functional verification, debugging, and compliance adherence. Additional responsibilities include coordinating technical efforts with cross-functional teams and supporting product development to ensure Good Manufacturing Practice (GMP). The validation engineer will also engage in hardware and software RTL design processes.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 contractorsMandatory 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:avnish.kumar@saracasolutions.com or connect with me here on LinkedIn.#Hiring #ValidationEngineer #QualificationEngineer #IQOQPQ #cGMP #FDA #PharmaJobs #EngineeringJobs #PhoenixJobs #Capgemini #OpenToWork