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 over 25 Fortune 500 clients across diverse industries, including MedTech, Aerospace, Automotive, and Defense. As an ISO 13485-certified organization, SARACA specializes in designing and developing innovative medical devices, with expertise in areas such as embedded software, UI/UX, and product testing. The organization has a team of over 400 skilled engineers and consultants with deep knowledge in product engineering and compliance with global standards like IEC 62304 and EU MDR. With a global presence, SARACA is dedicated to solving complex challenges, fostering innovation, and driving business growth for its clients. Committed to diversity and inclusion, SARACA offers a supportive work environment that encourages professional growth.
Role Description
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.
Responsebilities:
- Execute equipment & process validation
- Develop validation protocols & reports
- Perform risk assessments & CAPA
- Ensure compliance with regulatory standards
- Support audits and maintain documentation
Key Skills:
- IQ/OQ/PQ Validation
- FDA & GMP Compliance
- Risk Assessment & CAPA
- Manufacturing Process Validation
- MES / ERP Systems
Preferred Skills
- Food / Consumer / Pharma manufacturing industry
- Experience in regulated environments
- Exposure to audit and compliance processes