{"id":2325888,"url":"https://alion.io/job/quantiphi-associate-engagement-manager-gxp-validation-expert","title":"Associate Engagement Manager (GxP Validation Expert)","company":{"id":6155,"name":"Quantiphi","domain":"quantiphi.com","url":"https://alion.io/company/quantiphi","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"services","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"C","score":69,"open_postings":70,"ghost_share":0.514,"stale_share":0,"repost_share":0,"time_to_fill_p50_days":30,"computed_at":"2026-10-15T05:46:00Z"}},"role":"Solutions","role_family":"Solutions","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Mumbai, India","Bengaluru, India","Thiruvananthapuram, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":11500,"max_usd":31000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":490},"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"AWS","optional":false},{"name":"Azure","optional":false},{"name":"Azure DevOps","optional":false},{"name":"GCP","optional":false},{"name":"Hyper-V","optional":false},{"name":"IAM","optional":false},{"name":"Jira","optional":false},{"name":"SIEM","optional":false},{"name":"VMWare","optional":false},{"name":"CI/CD","optional":true},{"name":"CloudFormation","optional":true},{"name":"Terraform","optional":true},{"name":"Vault","optional":true}],"status":"live","first_seen_at":"2026-10-12T07:22:21Z","employer_posted_date":"2026-10-12","last_verified_at":"2026-10-14T14:37:09Z","board_verified":true,"closed_at":null,"days_open":3,"trust":{"level":"ok","repost_count":0,"flags":["company_stale"],"days_open":2},"description":"While technology is the heart of our business, a global and diverse culture is the heart of our success. We love our people and we take pride in catering them to a culture built on transparency, diversity, integrity, learning and growth.\nIf working in an environment that encourages you to innovate and excel, not just in professional but personal life, interests you- you would enjoy your career with Quantiphi!\nRole: Associate Engagement Manager - GxP Validation Expert\nExperience Level: 5-12 Years\nWork location: Mumbai, Bengaluru, Trivandrum\nRole & Responsibilities:\nThe ideal candidate will lead and execute GxP validation activities across various infrastructure components. This includes:\n Infrastructure Qualification: Leading IQ, OQ, and PQ for cloud platforms (AWS, Azure, GCP), virtualized environments, network components, and storage/backup systems.\n Validation Deliverables: Developing and reviewing key validation documents (Validation Plan, URS, FS/DS/CS, Risk Assessments, Traceability Matrix, Validation Summary Report) using a GAMP 5 risk-based approach.\n Hands-on Execution: Performing protocol execution with meticulous evidence capture (logs, screenshots, system outputs).\n Cloud Validation Strategy: Defining validation strategies for GxP-compliant cloud environments (IaaS, PaaS, SaaS) and qualifying cloud services (IAM, logging, encryption, backup/DR).\n Regulatory Compliance: Ensuring alignment with FDA (21 CFR Part 11) and EMA (EU Annex 11) regulations, applying ALCOA+ principles, audit trail requirements, and electronic records/e-signature controls.\n CSA & GAMP 5: Applying risk-based validation per GAMP 5, including system categorization and GxP impact assessment, and driving Computer Software Assurance (CSA) adoption.\nLifecycle Support: Supporting the validation lifecycle through periodic reviews, requalification, and change control impact assessments.\nCollaboration: Partnering with IT and DevOps teams for infrastructure changes, patch management, and configuration drift validation.\nPrimary Requirements:\nExperience: 5+ years in GxP CSV/Validation, with 3+ years specifically in hands-on Infrastructure Qualification.\n Technical Expertise: Proven hands-on experience in Cloud Qualification (AWS/Azure/GCP), Virtualization (VMware/Hyper-V), and Networking validation.\n Industry Background: Experience in regulated industries (Life Science, Healthcare, Medical Devices).\nSecurity & Compliance: Proficiency in IAM, RBAC, Encryption mechanisms, and SIEM/logging tools.\n Tools & Documentation: Familiarity with Validation tools (e.g., HP ALM, Azure DevOps, Jira) and creating essential Documentation (SOPs, Validation Plans, RTM).\nSecondary Requirements (Good to Have):\nExperience with specific GxP application systems (e.g., LIMS, QMS, MES, Veeva Vault).\nExperience with Infrastructure as Code (IaC) tools (Terraform, CloudFormation).\nKnowledge of DevOps / CI-CD validation practices.\nKnowledge of AI/ML system validation.\nExperience with automated testing tools.\nAbility to design validation strategies and troubleshoot qualification issues.\nIf you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!","description_format":"text","description_chars":3191,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Healthcare & Life Sciences Consulting","Document AI","Cloud Consulting & Migration","Data Engineering & 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