What are the responsibilities and job description for the Senior Validation Engineer position at SARACA?
Company Description
SARACA is a global engineering R&D services company working with over 25 Fortune 500 clients. With expertise spanning industries like MedTech, Aerospace, Automotive, and Semiconductor, SARACA delivers innovative solutions in embedded software, UI/UX, mechanical engineering, systems, and product testing. Their MedTech experience includes ISO 13485-certified design and compliance expertise in standards like IEC 62304 and EU MDR. Supported by a highly skilled team of 400 engineers and consultants, SARACA addresses complex challenges for clients worldwide. SARACA fosters an inclusive, innovative, and growth-focused work culture, enabling customers to achieve industry leadership.
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