What are the responsibilities and job description for the Validation Engineer position at SARACA?
Company Description
SARACA 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 Description
This 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 SOPs
- Develop and execute IQ/OQ/PQ protocols
- Conduct testing to ensure equipment performance under defined conditions
- Document test results, deviations, and corrective actions
- Ensure compliance with FDA and cGMP regulations
- Maintain accurate and audit-ready qualification documentation
- Collaborate with internal teams and external contractors
Mandatory Skills:
- Bachelor’s degree in Engineering / Life Sciences / related field
- 3–5 years of experience in equipment qualification & HVAC validation
- Strong knowledge of IQ/OQ/PQ processes
- Experience with cGMP and FDA regulatory standards
- Strong analytical, problem-solving, and documentation skills
- Proficiency in data analysis and reporting tools
- Ability 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.
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