What are the responsibilities and job description for the CSV Engineer position at TekOne IT Services Pvt. Ltd.?
Position Responsibilities
- Validation Expertise: Validate non-product software (e.g., development, testing, mechanical) within the healthcare domain, ensuring adherence to FDA guidelines.
- Risk Assessment: Conduct risk assessments to identify and prioritize validation activities effectively.
- Documentation Management: Create and maintain essential validation documentation, including User Requirements Specifications (URS), Validation Plans, Test Protocols (IQ, OQ, PQ), and Final Validation Reports.
- Execution of Validation Activities: Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities to ensure software tools operate as intended.
- Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including IT, quality assurance, and regulatory affairs, to align on validation strategies and maintain compliance.
- Regulatory Knowledge: Maintain an in-depth understanding of FDA guidance related to non-product software validation (e.g., 21 CFR Part 820) and familiarize yourself with risk management principles.
- Standards Familiarity: Be knowledgeable about GAMP 5 and Computer Software Assurance for Production and Quality System Software.
- Education: Bachelor’s or Master’s degree in Computer Science or a related field.
- Experience: Proven experience in software validation within regulated environments, with a solid track record in tool validation processes.
- Specialization: Experience with semiconductor manufacturing processes is preferred.
- Skills:
- Strong analytical and problem-solving abilities.
- Excellent communication and documentation skills.
- Ability to work effectively in cross-functional and cross-cultural global teams.
- Knowledge of various software testing methodologies.
- Proficient in validation tools and methodologies.
- Capability to work independently and collaboratively in a fast-paced environment.
