Designation: GxP Validation Engineer – Scientific Informatics Systems
Qualification: Bachelor's Degree in Computer Science, Information Technology, Biotechnology, Life Sciences, Pharmaceutical Sciences, Bioinformatics, Engineering or a related discipline. Equivalent combination of education and relevant industry experience may be considered.
Certifications: (Preferred)
- GAMP 5 Foundation or Advanced Certification
- Certified Computer System Validation (CSV)
- Regulatory Compliance Training (FDA 21 CFR Part 11, EU Annex 11)
- ITIL Foundation Certification
- Scientific Informatics or Laboratory Systems Training
Experience: Minimum 5+ years of hands-on experience in GxP Computer System Validation (CSV) within Pharmaceutical, Biotechnology or Life Sciences environments, with experience validating regulated laboratory and scientific systems such as SDMS, ELN, Empower CDS, LabX, SoftMax Pro, LIMS and related applications. Experience with BIOVIA Discoverant is preferred. Candidates should possess a strong understanding of FDA 21 CFR Part 11, EU Annex 11, GAMP 5, Data Integrity (ALCOA+) and validation lifecycle activities, including IQ/OQ/PQ, risk assessments, change controls, CAPA and audit readiness.
Work Location: Remote (India) - Working in collaboration with US Service Delivery Team, supporting US Biopharmaceutical clients.
Work Timing: Must be willing to work in US (PST) business hours
Client Brief: A pioneering biopharmaceutical leader, the 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, they have introduced ground breaking treatments across areas such as virology, oncology and inflammation. Their 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, they continuously invest in cutting-edge research and strategic partnerships. Their commitment to access, sustainability and patient-centric innovation has earned them accolades as one of the most admired and socially responsible companies in the healthcare industry.
Job Role: The GxP Validation Engineer will be responsible for planning, executing and maintaining Computer System Validation (CSV) activities for regulated Scientific Informatics and Laboratory Systems used across Research, Quality Control, Manufacturing and Clinical environments. The role will ensure compliance with global regulatory requirements, support validation lifecycle activities and maintain audit readiness of regulated systems throughout their lifecycle. The engineer will collaborate closely with Quality Assurance, Laboratory Operations, Manufacturing, IT, Business Stakeholders and Vendors to support implementation, upgrades, integrations and continuous compliance initiatives.
Key Responsibilities:
A) Computer System Validation
- Execute end-to-end Computer System Validation (CSV) activities for regulated laboratory and scientific applications.
- Develop, review and maintain validation documentation including:
- Validation Plans
- User Requirements Specifications (URS)
- Functional Specifications
- Risk Assessments
- IQ, OQ and PQ Protocols
- Traceability Matrix (RTM)
- Validation Summary Reports
- Develop and execute validation test scripts and document test evidence.
B) Compliance & Regulatory Support
- Ensure compliance with:
- FDA 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Data Integrity (ALCOA+)
- Internal Quality and Compliance Standards
- Maintain audit-ready documentation and support regulatory inspections and compliance audits.
- Participate in periodic reviews and revalidation activities.
C) Change Control & Lifecycle Management
- Perform impact assessments for system upgrades, patches, enhancements and configuration changes.
- Support Change Control, CAPA, Deviation Management and validation lifecycle processes.
- Participate in implementation, migration, upgrade and retirement activities for validated systems.
D) Cross-Functional Collaboration
- Work closely with:
- Quality Assurance
- IT Teams
- Laboratory Operations
- Manufacturing Teams
- Business Stakeholders
- External Vendors
- Provide validation guidance and compliance support throughout project lifecycles.
Required Skills:
A) Validation & Compliance
- Strong hands-on experience in Computer System Validation (CSV) within GxP-regulated environments.
- Experience preparing and executing validation deliverables including:
- URS
- Risk Assessments
- IQ/OQ/PQ
- RTM
- Validation Plans
- Validation Reports
- Thorough understanding of:
- FDA 21 CFR Part 11
- EU Annex 11
- GAMP 5
- Data Integrity (ALCOA+)
- Experience supporting regulatory inspections and compliance audits.
B) Scientific Informatics Systems
Hands-on validation experience with following systems:
- Scientific Data Management Systems (SDMS)
- Electronic Laboratory Notebooks (ELN)
- Waters Empower CDS
- LabX
- SoftMax Pro
- Laboratory Information Management Systems (LIMS)
Experience with BIOVIA Discoverant is highly preferred.
C) Validation Lifecycle Management
- Change Control Management
- CAPA Management
- Deviation Handling
- Risk-Based Validation Approaches
- Periodic Reviews
- Revalidation Activities
D) Technical Skills
- Understanding of Software Development Lifecycle (SDLC)
- Validation lifecycle methodologies
- Electronic Records and Electronic Signatures
- Audit Trail Reviews
- Data Integrity Controls
- Validation and test management tools such as Jira, HP ALM, Azure DevOps or similar platforms
Desired Skills:
- Experience validating cloud-based or SaaS applications.
- Knowledge of laboratory instrument integrations and data acquisition systems.
- Familiarity with Pharmaceutical R&D, Quality Control, Manufacturing and GMP processes.
- Experience supporting system upgrades, migrations and implementation projects.
- Exposure to scientific informatics ecosystems and laboratory automation platforms.
Personal Attributes:
- Strong commitment to quality, compliance and documentation excellence.
- Excellent analytical and problem-solving skills.
- Ability to work independently in highly regulated environments.
- Strong written and verbal communication skills.
- Effective stakeholder management and collaboration abilities.
- Self-motivated organized and capable of managing multiple priorities simultaneously.
Pay: Up to ₹3,000,000.00 per year
Benefits:
- Flexible schedule
- Provident Fund
- Work from home
Application Question(s):
- Years of hands-on experience in Computer System Validation (CSV) within GxP-regulated Pharmaceutical, Biotechnology, or Life Sciences environments?
- Years of experience validating Scientific Informatics and Laboratory Systems such as SDMS, ELN, Empower CDS, LabX, SoftMax Pro, LIMS, or related applications - Please mention which all Systems from the above list have you worked with?
- Years of experience creating and executing validation deliverables including URS, Risk Assessments, IQ/OQ/PQ, RTM, Validation Plans, Test Scripts, and Validation Reports?
- Do you have experience working with BIOVIA Discoverant (Manufacturing Analytics / CPV) platform - Yes / No ?
- Current - Cost to Company (CTC) ?
- Expected - Cost to Company (CTC) ? (Negotiable / Non Negotiable)
- Notice Period ? (Negotiable / Non Negotiable)
Work Location: Remote
