CSV Engineer

Job Overview

We are looking for an innovative and experienced Computer System Validation (CSV) Engineer to join our team. The CSV Engineer will be joining a quality team that is validating the quality of a new software/system. You will be responsible for oversight of all GxP regulated computerized systems at all applicable points of the computerized system lifecycle, ensuring compliance with regulatory requirements, Computer Systems Validation (CSV) and Lifecycle procedures with Data Integrity requirements.

Experience

Fresher to 2 Year

Responsibilities and Duties

· Preparation and review of Validation deliverables such as URS, GxP, Impact Assessment Checklist, VP, Specification documents (SDS, FRS, TS, CS), FRA, IQ Protocol & Scripts, OQ Protocol & Scripts, PQ Protocol & Scripts, DM (Data Migration) Protocol & Scripts, RTM, VSR, 21 CFR PART 11 & EU ANNEX 11 Compliance Checklist as per Webosphere CSV SOP.

· Execution/Support in the execution of IQ, OQ, PQ, and DM test scripts on the internal as well client side.

· Basic knowledge of industry standards related to computerized systems and Electronic Records/Electronic Signatures; 21 CFR Part 11, EU Annex 11, GAMP5.

· Coordinate with Client to carry out Validation activity of Computerized Systems and Software.

· Responsible for achieving & maintaining the validated status of in-scope computerized systems.

· Provide guidance on CSV validation issues and discrepancies.

· Support investigation of CSV defects and quality records (deviation, CAPAs).

· Ensuring systems are fully implemented and integrated with other quality management systems, site and global functions.

· Coordinating with teammates in achieving assigned tasks.

· Issue/bug tracking, and software incident management.

· Develop and execute test plans to ensure that all objectives are met.

· Implement and monitor test scripts to assess functionality, reliability, performance, and Coordinate and support to Quality Manager.

· Ensure that user expectations are met during the testing process.

· Documentation adherence to internal/Client SOP and compliance.

· Managing department functional process as specified in standard operation procedure & suggest changes if required.

Qualifications

· Bachelor’s/Master’s degree in Pharmacy, Life Sciences, Biotechnology, Computer Science, IT, or a related discipline.

· Good knowledge and practical understanding of Computer System Validation (CSV) principles, processes, and validation lifecycle.

· Experience in preparing, reviewing, and executing CSV documentation such as URS, Validation Plan (VP), Specifications, FRA/RA, IQ, OQ, PQ, RTM, VSR, and Compliance Checklists.

· Good understanding of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity, and ALCOA+ principles.

· Knowledge of Document Management practices, including document preparation, review, approval, version control, issuance, archival, retrieval, and maintaining controlled documentation.

· Understanding of SDLC and its relationship with the CSV lifecycle.

· Basic understanding of Change Control, Deviations, CAPA, Incident/Defect Management, and Periodic Review processes.

· Ability to identify validation gaps, compliance risks, documentation inconsistencies, and potential quality issues.

· Strong technical writing and documentation skills with excellent attention to detail.

· Good written and verbal communication skills with the ability to coordinate effectively with QA, IT, business users, customers, and technical teams.

· Strong soft skills, including communication, teamwork, adaptability, problem-solving, time management, and interpersonal skills.

· Demonstrates a strong sense of accountability and ownership for assigned validation activities, deliverables, timelines, and commitments.

· Possesses a strong quality mindset, with a focus on accuracy, compliance, completeness, traceability, and right-first-time documentation.

· Ability to take initiative, accept challenges, learn new concepts, and continuously improve technical and regulatory knowledge.

· Strong critical-thinking and problem-solving abilities, with the ability to analyse issues logically and propose practical solutions.

· Ability to manage multiple validation activities, prioritize tasks, and meet committed timelines.

· Ability to work independently with minimal supervision as well as collaboratively within cross-functional teams.

· Proficiency in MS Office tools, particularly Word, Excel, PowerPoint, and related documentation tools.

Apply Now : 9571305277

Pay: Up to ₹400,000.00 per year

Work Location: In person