Computer System Validation Engineer
Computer System Validation Engineer
Posted on :
21-02-2025
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1 Vacancy
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Job Description
Computer System Validation Engineer
Chennai India
Indian Time shift (Some overlap to US time)
Key Responsibilities
Requirements Gathering & Analysis: Collaborate with IT Quality and business stakeholders to elicit analyze translate and document business requirements into functional and technical specifications.
Preparation and Execution of Validation Deliverables as per GAMP5 and 21 CFR Part 11 requirements.
Perform validation activities of Computerized Systems in the Life Sciences/Pharma Industry.
System Implementation & Support: Work with business users to configure systems resolve bugs and implement enhancements.
SOP Development: Draft and update SOPs templates and operational documentation to align with regulatory standards.
System Administration: Manage user access provisioning security roles and configuration management for supported systems.
Stakeholder Engagement: Partner with global teams to ensure timely project delivery meeting regulatory compliance standards (e.g. CFR Part 11).
Training & Manuals: Develop user manuals and provide training to ensure effective system usage by the business community.
Requirements
Minimum 3 years in IT and/or R&D and Quality operations within the biotech or life sciences industry.
5 years of experience implementing solutions for quality clinical operations and regulatory affairs.
Handson experience with Veeva Vault Benchling or similar platforms is required.
Knowledge of clinical trial management regulatory operations and Computer Systems Validation (CSV).
Familiarity with Software Development Life Cycle (SDLC) policies in regulated environments.
Education:
Bachelor s degree in Computer Science Pharmaceutical Science Biochemistry Chemistry or related fields is required.
Master s degree preferred.
Technical Skills:
Demonstrated expertise in writing software requirements test specifications and validation protocols.
Proficiency in managing global/regional projects with crossfunctional teams.
Certifications (Preferred):
Training in Clinical Trial Management Regulatory Operations and CFR Part 11.
CBAP or ISTQB Certifications
Skills:
veevavalidation & testing stakeholder engagement validation system administration software development life cycle computer systems validation cfrcomputerized system validation (csv) requirements gathering benchling documentation clinical trial management life sciences regulatory operations sop development veeva vault training & manuals system implementation & support
Write, edit, review, and approve lifecycle documentation for computerized systems. URS, FRS, CDS, CS, ERES assessments, IA, IOQ Use both Veeva and Kneat to do the above Integrate equipment with DeltaV and PI historian using OPC, EtherNet/IP, PI interfaces and PI connectors Execute IQs and IOQs in Kneat on DeltaV
Education
Bachelors degree
Employment Type
Full Time
Company Industry
Key Skills
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