What are the responsibilities and job description for the Manufacturing Qualification Engineer (IQ/OQ/PQ) position at SARACA?
Company Description SARACA is a global engineering R&D services company serving over 25 Fortune 500 customers across industries including MedTech, Aerospace, Rail, Automotive, Semiconductor, Defense, and Farm equipment. The company is ISO 13485 certified and has extensive experience with all classes of medical devices, covering embedded software, UI/UX, mechanical systems, and product testing. SARACA has unique expertise in IEC 62304, EU MDR, and scientific and regulatory writings such as Clinical and Performance Evaluation Reports. With a technically proficient team of 400 engineers and management consultants, SARACA delivers solutions to complex business problems through onsite and offsite projects worldwide. SARACA is an equal-opportunity employer that fosters a culture of innovation, continuous learning, and customer-focused growth.
Role Description This is an on-site contract role for a Manufacturing Qualification Engineer (IQ/OQ/PQ) located in Richmond, VA. The individual in this role will plan, execute, and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment and systems. Day-to-day responsibilities include preparing and reviewing qualification protocols, coordinating and performing tests, analyzing data, and ensuring that equipment meets regulatory and quality requirements. The engineer will collaborate closely with manufacturing, quality assurance, maintenance, and laboratory teams to troubleshoot issues, manage deviations, and implement corrective and preventive actions. The role also involves maintaining detailed records, supporting audits and inspections, and contributing to continuous improvement of qualification processes and standards.
Key Responsibilities:
✔️ Execute and document Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities
✔️ Develop, review, and approve qualification protocols and reports
✔️ Perform equipment qualification and process validation
✔️ Investigate deviations and support CAPA activities
✔️ Ensure compliance with FDA and cGMP regulations
✔️ Prepare qualification documentation for audits and regulatory inspections
✔️ Collaborate with cross-functional teams to ensure successful qualification and validation activities
Required Qualifications:
✅ Bachelor's degree in Engineering, Life Sciences, or a related field
✅ 3–5 years of experience in equipment qualification or validation within a regulated industry
✅ Hands-on experience with IQ/OQ/PQ execution and documentation
✅ Strong knowledge of FDA regulations and cGMP requirements
✅ Experience with validation protocols, process validation, deviation investigations, and quality documentation
✅ Excellent communication and problem-solving skills
If you're interested or know someone who would be a great fit, please send your updated resume or reach out to me directly or avnish.kumar@saracasolutions.com