Validation / Quality Engineer
venkatesh Kulkarni
Position: Software Validation & Documentation Specialist
Duration: Contract
Mode: [Remote]
Project Overview
The project involves validating and documenting software installed on laboratory instruments in compliance with EMA regulatory guidelines. The selected professional will be responsible for transitioning the management of instrument software to PPD IT Software Management SOPs, ensuring all software requirements, configurations, and operational details are accurately captured and maintained.
Key Responsibilities
Validate and document software installed on laboratory instruments in accordance with regulatory standards.
Collect, analyze, and document business and technical requirements.
Develop, execute, and maintain software validation test cases.
Prepare comprehensive software specifications, configuration details, and supporting documentation.
Design infrastructure and data flow diagrams to support system understanding and traceability.
Conduct risk assessments related to software and system configurations, ensuring compliance and mitigating potential issues.
Collaborate with cross-functional teams including IT, QA, and laboratory operations to ensure software validation aligns with organizational SOPs.
Required Skills and Qualifications
Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related field.
Proven experience in software validation, documentation, or regulatory compliance (preferably in a laboratory or healthcare domain).
Strong technical writing and documentation skills.
Excellent verbal and written communication abilities.
High attention to detail with strong organizational and analytical skills.
Familiarity with EMA, FDA, or GxP guidelines is an added advantage.
Proficiency with tools for documentation and diagram design (e.g., Visio, Lucidchart, Confluence, MS Office).
Preferred Skills
Experience working in a regulated environment (pharmaceutical, biotech, or healthcare).
Knowledge of software development lifecycle (SDLC) and validation principles.
Understanding of risk management frameworks and change control processes.
Address: 3400 State Route 35, Suite 9B, Hazlet, New Jersey, 07730 USA