*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 robust 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 complete 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 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, th

📌 GxP - Computer System Validation Engineer (Scientific Informatics Systems) (India)
🏢 ITSoli India
📍 India