Designation: GxP Computer System Validation (CSV) Engineer
Qualification: Bachelor’s or Master’s degree in Computer Science, Information Technology, Life Sciences, Pharmacy, or a related discipline.
Experience: Minimum 5+ years of GxP Computer System Validation (CSV) experience within regulated Pharma/Biotech environments, with strong exposure to end-to-end validation lifecycle, compliance standards (21 CFR Part 11, EU Annex 11, GAMP 5), and validation of systems such as LIMS, ELN, and SDMS.
Work Timing: Once the Knowledge Transfer (KT) period for new joiners is completed, they will be required to work entirely in US (PST) hours (IST 9:00 PM to 5:00 AM). During the initial KT period of 3 months, the work schedule will also strictly follow full US (PST) working 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 groundbreaking 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: We are seeking a skilled GxP Computer System Validation (CSV) Engineer to support validation lifecycle activities for regulated systems within a Life Sciences environment. The role involves ensuring compliance with global regulatory requirements such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. The ideal candidate will collaborate with cross-functional teams to validate systems including LIMS, ELN, SDMS, and other GxP applications, ensuring data integrity, audit readiness, and adherence to quality standards.
Key Responsibilities:
- Execute end-to-end Computer System Validation (CSV) lifecycle activities
- Develop and review validation deliverables such as Validation Master Plans (VMP), User Requirement Specifications (URS), Functional/Design Specifications (FS/DS), IQ/OQ/PQ protocols and reports
- Ensure compliance with GxP regulations including FDA 21 CFR Part 11 and EU Annex 11
- Perform risk assessments and implement GAMP 5 risk-based validation approaches
- Support system implementation, upgrades, and change control processes
- Conduct periodic reviews, deviation management, CAPA handling, and audit support
- Collaborate with IT, QA, business stakeholders, and vendors for validation activities
- Ensure data integrity principles (ALCOA+) are maintained across systems
- Participate in regulatory inspections and internal audits
Required Skills:
- Strong hands-on experience in GxP CSV within Pharma / Biotech environments
- In-depth knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5
- Experience with validation of systems such as LIMS, ELN, SDMS, QMS, or ERP (GxP-relevant modules)
- Expertise in validation documentation and lifecycle management
- Knowledge of data integrity principles (ALCOA+)
- Familiarity with change control, deviation, and CAPA processes
- Strong stakeholder communication and documentation skills
Desired Skills:
- Experience with cloud-based GxP systems validation (AWS / Azure environments)
- Exposure to automation tools for validation or testing
- Knowledge of Agile / DevOps methodologies in regulated environments
- Experience with regulatory audit readiness and inspection handling
- Basic understanding of scripting or database validation (SQL, Python)
Personal Attributes:
- Strong attention to detail and quality mindset
- Analytical and problem-solving skills
- Ability to work in a cross-functional, global team environment
- Proactive, self-driven, and adaptable to dynamic project needs
- Excellent written and verbal communication skills
- High level of integrity and accountability in regulated environments
Job Type: Full-time
Pay: Up to ₹2,000,000.00 per year
Benefits:
- Provident Fund
- Work from home
Experience:
- validating GxP (LIMS / MES / ERP / QMS) systems: 3 years (Required)
- GxP CSV within (Pharma/Biotech) environment: 5 years (Required)
- compliance (21 CFR Part 11, EU Annex 11, GAMP 5) frameworks: 3 years (Required)
- validating (LIMS, ELN, SDMS, ERP, other GXP) systems: 3 years (Required)
- end-to-end validation (URS, FS/DS, IQ/OQ/PQ, VMP, etc.): 3 years (Required)
Shift availability:
- Overnight Shift (Required)
Work Location: Remote
