GxP - Computer System Validation Engineer (Scientific Informatics Systems)

*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 complete US (PST) working hours*

*Client Brief:* *A pioneering…

Skills

• Azure