Venkat Manohar M.
Validation Lead | CQV, CSV / CSA, Change Controls & Data Integrity | Delta V, Automation, Utilities, HVAC, Facilities | FDA & EMA‑regulated Pharma/Biotech
- Role
- Cqv Engineer at Dynamixe, Inc. By Efor
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Venkat Manohar M.
Validation Lead with 8+ years of experience across automation, manufacturing, utilities, facility systems, and process/computer system validation (CSV) in FDA‑ and EMA‑regulated pharmaceutical, medical device, and biotech environments. At my previous role at Pfizer Rocky Mount, NC site I lead CQV, CSV, and change control activities that keep products, processes, and data compliant and audit‑ready.My core focus areas include:CQV & CSV for process equipment, clean utilities, Automation, HVAC, and facility systems (URS, FDS/SDS/HDS, FAT/SAT, IQ/OQ/PQ, PPQ, CPV, Alarm Assessments, Computer & Equipment Classification Assessments, RTM, SOP Drafting, Line Templates, SOJTs)Computer System Validation and Data Integrity (21 CFR Part 11, ER/ES, GAMP‑aligned life cycle, risk‑based CSV)Change Controls, deviations, CAPAs, risk assessments (pFMEA, FMEA, 5 Why, Fishbone) and inspection readinessCross‑functional collaboration with Automation, Packaging, Maintenance, Project Management, Manufacturing, QA, IT, and Engineering to deliver validated systems on timeOwned validation life cycle documents and execution (URS to PQ) for 75+ systems at Pfizer, contributing to successful internal and regulatory inspections with zero major validation observations.Led change controls, deviation resolution, and validation protocol execution that reduced recurring issues by 40% and improved right‑first‑time execution across automation and utilities.Performed data integrity and Part 11 assessments at Lonza and Takeda, driving remediation plans and SOP improvements that strengthened GxP compliance across lab and manufacturing systems.I hold a master’s in Industrial Engineering (St. Mary’s University) and a bachelor’s in Mechanical Engineering (NIT Raipur), plus training in Lean Six Sigma, QMS auditing, and automation and control systems. I am actively pursuing Validation Lead/Senior/Manager opportunities in pharmaceutical and biotech organizations where I can own site/system validation strategy, guide teams through complex CQV/CSV programs, and support reliable, compliant supply of medicines to patients.
Experience
Cqv Engineer
Feb 2026 — Present · Wilson, NC, US
Responsible for generating and executing Pre-commissioning, Shakedown testing, SAT, IV/OV of site wide Clean (WFI, Clean Steam, Clean Compressed Air, Process gases, vacuum,CIP/SIP), Black Utilities (Compressed Air, Chilled water, Hot Water, Plant Steam, PortableWater), Upstream, Downstream, Process and HVAC systems.Commissioned Colling Towers, Pump skids, Brine Maker, Plant steam boilers, Natural gas lines, Process waste Tanks, Chiller Units, Boiler units.Participated in qualification activities of Honeywell BMS, Delta V DCS for Utility systems.Drafted Area set up plans for each piece of equipment in the Central Utility Building plant.Co-ordinated with Vendors on SAT, Shake down testing.Drafted Job hazard analysis (JHA), SPA for the Black Utilities area.
Education
National Institute of Technology Raipur
Bachelor's degree, Mechanical Engineering
Infercon Automation
MASTER DIPLOMA IN AUTOMATION AND CONTROL SYSTEM ENGINEER, Automation
St. Mary's University
Master's degree, Industrial Engineering
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