We’re Hiring: Validation EngineersLocation: HyderabadExperience: 4–7 yearsJoining: ImmediateEmail your resume to: hr@pharmateksol.comVisit us @: https://pharmateksol.com/ Are you passionate about delivering quality and compliance for emerging life sciences companies across the globe? At Pharmatek Solutions, you’ll work on cutting-edge, GxP-compliant SaaS solutions that are widely used by emerging global pharma and biotech companies. We’re expanding our team and are hiring:Validation Engineers (4–7 years experience) What You’ll Do Validate GxP systems in Quality, GCP, and GLP domains — including Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Electronic Trial Master Files (eTMF), Drug Safety Systems, Regulatory Submission Platforms, Learning Management Systems (LMS), Quality Management Systems (QMS), and Laboratory Information Management Systems (LIMS)Experience with Veeva applications is a strong plusExperience with Enterprise Resource Planning (ERP) eg. SAP S/4HANA, NetSuite ERP etc. and Enterprise Management System (EMS) like IBM Maximo, Oracle NetSuite etc. is preferredAuthor, review, and approve key CSV documents — including Validation Plans/Summary Reports, Traceability Matrices, Change Controls, Risk Assessments, Specifications, and IQ/OQ/PQ (Qualification) protocolsEnsure systems meet 21 CFR Part 11 and data integrity standardsPartner with IT teams & vendors to validate and implement new IT systemsParticipate in GxP computer system audits ensuring compliance & make sure vendors are qualified before implementationOwn and manage CAPAs and CSV deviationsConduct audit trails and periodic reviews with IT and process ownersAuthor & continuously improve CSV procedures, forms, and training content What You’ll Bring Strong understanding of GxP CSV principlesHands-on experience with compliance documentation and entire system lifecycleExcellent communication, documentation, and collaboration skills Why Join Pharmatek? Accelerate your career with challenging roles and mentorship from globally respected industry leadersMake an impact by working with emerging, global pharma and life sciences companiesStay ahead with a company that values compliance, innovation, and continuous learningThrive in a people-first culture that supports work-life balance Ready to take your validation career to the next level? Apply now or share this opportunity with someone who could be a great fit!#ValidationEngineers #ComplianceCareers #Pharmatek Solutions Inc. #Vinay Parachuri #Bala Satish K #Subin Abraham

🧬 About the Project: Join a mission-critical greenfield project, as we validate enterprise-level systems supporting biologics manufacturing. This role involves comprehensive Computer System Validation (CSV) and Computer Software Assurance (CSA) aligned with GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines, using Agile and DevOps methodologies. 🔧 Key Responsibilities: Develop and execute validation deliverables: URS, FRS, Risk Assessments, IQ/OQ/PQ protocols, and VSR. Validate systems including SAP ERP, LIMS (LabWare), MES (Werum PAS-X), SCADA/PLC/HMI, and enterprise Data Lakes (AWS/Azure). Leverage Veeva Vault for e-validation document management and traceability. Collaborate with cross-functional teams: QA, IT, Manufacturing, and Labs. Perform realistic workload simulations, system integration tests, and streaming ingestion validations. Ensure audit readiness, data integrity, and compliance with ALCOA+ principles. Apply CSA methodology: functional criticality assessments and risk-based testing strategies. 🎓 Qualifications: 6+ years experience in CSV/CSA within the pharmaceutical or biotech industry. Strong understanding of regulatory requirements: 21 CFR Part 11, EU Annex 11, GAMP 5, ISPE C&Q. Expertise in one or more systems: SAP, LIMS, MES, Data Lake, SCADA/PLC. Hands-on experience with Veeva Vault and Agile/DevOps project environments. Experience in greenfield or biologics manufacturing projects preferred. Strong documentation and validation lifecycle skills (URS → VSR). Excellent communication and stakeholder engagement skills.