Remote Computer system validation Jobs – 103 Open Jobs Today

ELN Computer System Validation (CSV) Engineer
ITSoli India Pvt Ltd. —Remote
- Up to ₹20,00,000 a year
- Overnight shift
- Remote
- Computer Science
- DevOps
- Laboratory experience
- Work from home
- Flexible schedule
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GxP Computer System Validation (CSV) Engineer - Biovia (ELN / Discoverant)
ITSoli India Pvt Ltd. —Remote
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- Overnight shift
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- Azure
- Computer Science
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- Work from home
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7d
Discoverant Computer System Validation (CSV) Engineer
ITSoli India Pvt Ltd. —Remote
- Up to ₹25,00,000 a year
- Overnight shift
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- Computer Science
- Master's degree
- SQL
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GXP Computer System Validation (CSV) Engineer
ITSoli India Pvt Ltd. —Remote
- Up to ₹20,00,000 a year
- Overnight shift
- Remote
- Azure
- Computer Science
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- Work from home
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- Microsoft Excel
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Discoverant System Administrator
ITSoli India Pvt Ltd. —Remote
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- Overnight shift
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ELN Computer System Validation (CSV) Engineer

ITSoli India Pvt Ltd.
Remote

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Job details

Permanent | Full-time
Up to ₹20,00,000 a year

Benefits

Provident Fund
Work from home
Flexible schedule

Qualifications

Computer Science
DevOps
Laboratory experience
.NET
Master's degree
Analysis skills
Quality assurance
Bachelor's degree
Scripting
Agile
SaaS
Communication skills
Python
FDA regulations
Information Technology

Full job description

Designation: ELN Computer System Validation (CSV) Engineer

Qualification: Bachelor’s or master’s degree in Life Sciences, Computer Science, Information Technology or a related discipline.

Experience: Minimum 3+ years of hands-on CSV experience in GxP Life Sciences environments, with expertise in ELN systems (Biovia preferred), validation lifecycle (URS to VSR) and regulatory compliance (FDA 21 CFR Part 11, EU Annex 11, GAMP 5).

Work Timing: Work schedule can be split into 4 hours PM (IST) and 4 hours AM (PST) working hours once KT (Knowledge Transfer) days are completed for new Joiners – During KT Period (i.e. 3 months) work schedule will be complete US (PST) working hours.

Client Brief: A pioneering biopharmaceutical leader, our organization is driven by a mission to discover, develop and deliver transformative therapies that improve the lives of people around the world. With a deep focus on innovation, we have introduced groundbreaking treatments across areas such as virology, oncology and inflammation. Our trailblazing work has contributed to global advancements in HIV treatment and the fight against viral diseases. Recognized for a robust pipeline and a legacy of scientific excellence, we continuously invest in cutting-edge research and strategic partnerships. Our commitment to access, sustainability and patient-centric innovation has earned us accolades as one of the most admired and socially responsible companies in the healthcare industry.

Job Role: We are seeking a skilled ELN CSV Engineer to support validation activities for Electronic Laboratory Notebook systems in regulated Life Sciences environments. The role involves ensuring compliance with global regulatory standards while managing validation lifecycle activities for ELN platforms, with a strong preference for experience in BIOVIA-based applications. The candidate will collaborate with cross-functional teams including IT, Quality and Business stakeholders to ensure validated, compliant and audit-ready systems.

Key Responsibilities:

Execute end-to-end CSV lifecycle activities for ELN systems (planning, execution and reporting)
Develop and review validation deliverables including Validation Plans, URS, FS/DS, Risk Assessments, IQ/OQ/PQ protocols and Summary Reports
Ensure compliance with regulatory standards such as FDA 21 CFR Part 11, EU Annex 11 and GAMP 5 guidelines
Perform impact assessments, change control evaluations and periodic reviews
Support audit readiness and participate in internal/external audits and inspections
Collaborate with IT, Quality Assurance and business stakeholders to gather and define system requirements
Ensure data integrity, system security and compliance with ALCOA+ principles
Support incident management, deviation handling and CAPA processes
Work closely with ELN platform teams for system enhancements, upgrades and integrations

Required Skills:

Strong hands-on experience in Computer System Validation (CSV) in GxP environments
Experience with Electronic Laboratory Notebook (ELN) systems (BIOVIA preferred)
In-depth knowledge of validation lifecycle documentation (VMP, URS, FS/DS, IQ/OQ/PQ)
Good understanding of regulatory compliance: FDA 21 CFR Part 11, EU Annex 11, GAMP 5
Experience in risk-based validation approaches and data integrity principles (ALCOA+)
Familiarity with change control, deviation management and CAPA processes
Strong documentation, review and stakeholder communication skills

Desired Skills:

Experience with BIOVIA ELN or related laboratory informatics platforms
Exposure to LIMS, SDMS or other Lab Informatics systems
Knowledge of cloud-based validation and SaaS platforms
Basic understanding of scripting or system configuration (e.g., Python, .NET)
Experience with Agile/DevOps environments in validated systems

Personal Attributes:

Strong analytical and problem-solving mindset
Detail-oriented with a focus on quality and compliance
Excellent communication and stakeholder management skills
Ability to work independently and in cross-functional teams
Proactive, adaptable and audit-ready approach

Job Types: Full-time, Permanent

Pay: Up to ₹2,000,000.00 per year

Benefits:

Flexible schedule
Provident Fund
Work from home

Experience:

Computer System Validation (CSV) within GxP environments: 3 years (Required)
Electronic Laboratory Notebook (ELN) systems: 2 years (Required)
executing end-to-end validation lifecycle activities : 2 years (Required)
Regulatory Compliance (21 CFR Part 11, EU Annex 11, GAMP 5): 2 years (Required)

Shift availability:

Night Shift (Required)
Overnight Shift (Preferred)

Work Location: Remote

Quick apply

Refine Your Search

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ELN Computer System Validation (CSV) Engineer

GxP Computer System Validation (CSV) Engineer - Biovia (ELN / Discoverant)

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