Validation (CSV) Engineer - Biovia ELN (Electronic Laboratory Notebook)

ITSoli India Pvt Ltd.; Singapore; Remote; SGD 80,000 - 100,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Validation (CSV) Engineer specializing in Biovia ELN. This role involves overseeing the validation lifecycle for GxP-compliant systems, requiring strong expertise in regulatory standards and documentation processes. Ideal candidates will have a background in life sciences with a proven track record in validation within an R&D setting.

Qualifications

• Minimum 3+ years of hands-on experience in Computer System Validation (CSV).
• In-depth knowledge of Biovia ELN validation.
• Experience in writing and executing validation documentation (VP, URS, IQ, OQ, PQ).

Responsibilities

• Plan, execute, and document validation activities for Biovia ELN.
• Author and review validation deliverables including Validation Plan and Test Protocols.
• Participate in audits and inspections, providing validation documentation.

Skills

GxP regulations awareness

Validation documentation skills

Analytical skills

Communication skills

Education

Bachelors or Masters degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Computer Science

Tools

Biovia ELN

Veeva Vault

Master Control

SharePoint

Job description

Validation (CSV) Engineer - Biovia ELN (Electronic Laboratory Notebook)

Designation: Validation (CSV) Engineer - Biovia ELN (Electronic Laboratory Notebook)Qualification: Bachelors or Masters degree in Life Sciences, Pharmaceutical Sciences, Biotechnology, Computer Science, or a related technical field.Experience: Minimum 3+ years of hands-on experience in Computer System Validation (CSV) of Biovia ELN (Electronic Lab Notebook) or similar GxP-regulated R&D applications.Work Timing: US (PST) Hours (Work schedule can be split into 4 hours IST and 4 hours PST working hours once KT (Knowledge Transfer) days are completed for new Joiners - depending on daylight saving)Client Brief: Founded with a mission to advance global health, this leading biopharmaceutical company is dedicated to discovering, developing, and delivering innovative medicines that address life-threatening diseases. With a strong focus on virology, oncology, and inflammatory diseases, the company has pioneered groundbreaking treatments that have transformed patient care worldwide. Committed to scientific excellence and access to healthcare, it continuously strives to expand its portfolio through cutting-edge research, strategic collaborations, and a deep commitment to improving lives. Driven by innovation and a patient-centric approach, the company remains at the forefront of medical advancements, shaping the future of healthcare.Job Role: As a Validation (CSV) Engineer, you will be responsible for leading and executing the validation lifecycle of GxP-regulated R&D systems, with a strong focus on Biovia ELN. You will work closely with global stakeholders, QA, IT, and business teams to ensure compliance with 21 CFR Part 11, GAMP 5, and relevant regulatory standards.Key Responsibilities: Plan, execute and document validation activities for Biovia ELN and associated scientific systems. Author and review validation deliverables including Validation Plan, User Requirements, Risk Assessments, Test Protocols (IQ/OQ/PQ), Traceability Matrix, and Validation Summary Reports. Work with IT and business stakeholders to gather system requirements and ensure compliance with internal SOPs and regulatory guidelines. Support periodic reviews, change controls, and re-validation processes. Participate in audits and inspections by regulatory bodies and provide validation documentation as needed. Collaborate with system vendors, internal QA, and compliance teams for validation-related activities. Ensure proper ALCOA+ principles and data integrity practices are followed throughout the validation process. Provide guidance on best practices for GxP documentation and SDLC processes in an Agile/Waterfall hybrid environment.Required Skills: In-depth knowledge and hands-on experience with Biovia ELN validation. Strong understanding of GxP regulations (21 CFR Part 11, Annex 11, GAMP 5). Experience in writing and executing validation documentation (VP, URS, IQ, OQ, PQ, etc.). Familiarity with CSV tools and Document Management Systems (e.g., Veeva Vault, Master Control, or SharePoint). Strong analytical and problem-solving skills. Excellent verbal and written communication skills to work with US-based teams.Desired Skills: Experience with other Biovia suite tools (e.g., Biovia Pipeline Pilot, Biovia Workbook). Working knowledge of Agile methodologies or experience in Agile GxP environments. Understanding of cloud-based and on-prem scientific system deployments. Familiarity with data integrity assessments and Audit Trail Reviews.Personal Attributes: Self-starter with strong attention to detail and quality mindset. Flexible and adaptable to work across time zones and changing priorities. Ability to work independently and in a cross-functional team environment. Strong interpersonal skills to collaborate with diverse teams across geographies. Commitment to continuous learning and staying updated on regulatory trends.Job Types: Full-time, PermanentSchedule: Monday to Friday US shiftExperience: Validation (CSV) Engineer: 3 years (Required) Biovia ELN (Electronic Lab Notebook): 2 years (Required) (Biopharma / Life sciences) domain: 2 years (Required)Shift availability: Night Shift (Required) Overnight Shift (Preferred)Work Location: Remote,

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