A Senior Validation Engineer takes responsibility for planning, creating, and executing tests to check the company’s manufacturing equipment and ensure that it meets quality, performance, and safety standards. While specific duties are determined by where the engineers work, the following are certain core tasks seen on the Senior Validation Engineer Resume – calibrating manufacturing equipment, designing and performing validation tests; analyzing equipment test results; correcting quality issues; creating and recording documentation of all measures taken, and developing quality improvement plans for long-term or future references.
Employers pick resumes denoting the following skills – good understanding of manufacturing processes; quality testing skills; the ability to develop ways to generate and check complex data for solving problems; and troubleshooting skills. This role is suitable for engineering degree holders with strong industry knowledge.
Summary : Software/Firmware Engineer, post-Silicon Validation Engineer, pre-Silicon Verification Engineer. Worked Technical Leader and Individual Contributor. Contributed to multiple successful hardware/software products ranging from Intel's flagship Server Processors, DSP/VOIP SoC, Network Processor SoC, Embedded Systems and Development Toolsets.
Served individual contributor on loan from post-Si debug capabilities team (at Carolina) to pre-Si Architecture Verification team (at Santa Clara).
Authored part of global PSMI Snippet test plan; needed to clarify with DFD architects on hooks supporting PSMI flow steps.
Wrote PCU (Power Control Unit) PSMI test snippets (in Specman) in Xeon uncore test bench environment.
Confirmed critical PCU PSMI HW issues in early pre-Silicon phase.
Got invited to contribute rogramming skills realize idea.
Wrote a C++ random transaction test macro module for driving PSMI state snapshot data collection and flagging determinism violations.
Published a technical paper on the PSMI tagging approach.
M.S. In Computer Science
Sr. Senior Validation Engineer Resume
Headline : Proven record fourteen years of experience in biotechnology, pharmaceutical , medical device industry environment. Experience as Technology Transfer Project Manager, Validations, QA and compliance, expertice in rwgulatory documents. Knowledge in Utilities Process Water (WFI/ USP), Pharmaceutical Manufacturing Utilities support, Investigation Reports, Change Controls, Deviations, Corrective and Preventive Actions, Project Schedule, Management of Construction Operations, and Commissioning & Validation (IQ, OQ and PQ).
Skills : Microsoft Office, Trackwise, Microsoft Project.
Wrote discrepancy reports arise during Functional Test and Installation Verification and assure its completion Documentation, closure and review of discrepancy reports related to commissioning and / or qualification test cases.
Coordinated meetings that provide support to resolve issues found during Functional test execution Full technical responsibility for interpreting, organizing, executing, coordinating and carrying out technical assignments/programs with extensive and diversified requirements.
Followed up issues that arise during test execution and assure its completion Development and execution of Site Acceptance Test of several equipments Support various Change Controls within limited time frame available as part of new product introduction inspection and packaging.
Responsible for Validation, Maintenance, Regulatory Affairs) to ensure timely completion and closing of CR.
Followed up equipment and documentation changes (including change in Forms and SOP's).
Developed the IOQ and summary reports for Inspection Booths for PD Laboratory, AML-1 Packaging area andAML-14 in line inspection for syringe and vial line.
M.B.A. In Technology Management
Jr.Senior Validation Engineer Resume
Summary : Project management professional with over 20 years of experience managing , supporting multiple stages of project management from initiation to closeout.
Skills : Program / Project Management, Computer System Validation,.
Directed and guided project execution for validation teams on projects ranging from $750K to $5M in size domestic and international.
Validated and commissioned million dollar expansion projects including writing IQ/OQs for clean rooms, CIP systems, vessels and wide range of processes and process support systems.
Participated on one of first projects to implement new modular design for utility process systems.
Coordinated development and execution of documentation related to validated systems including SOPs, protocols and completion reports.
Facilitated project meetings and assign action items for various departmental personnel.
Acted in HR capacity by providing time sheet training, coordinating travel and lodging for short term and long term site resources.
Coordinated team meetings to achieve project deliverable and support all activities.
Masters In Management
Asst.Senior Validation Engineer Resume
Headline : Extensive experience with Bio-Pharma process equipment, control systems, computer validation, process & product validation, BMS/HVAC, utilities laboratory equipment qualifications. Knowledgeable in SOP's, ISA Standards, P& ID and MSDS regulations , Preventive Maintenance procedures. Knowledge in Maximo, SAP, (Maintenance and Inventory) Program and Trackwise.
Skills : Microsoft Word, Excel, Outlook, Project, Visio.
Responsible for preparing executing commissioning, equipment, utilities and facility protocols (IQ/OQ/PQ) in process validation.
Responsible for preparing and executing computer validation deliverables (functional requirements, system specifications, validation plan, protocols and SOP's in area such as: PLC (Allen Bradley), HVAC and manufacturing equipment.
Responsible for preparing SOP's and Preventive Maintenance documents for systems above.
Responsible for supervise validation specialists to complete tasks on programmed schedule.
Supported client QA in cGxP document review approval process, mentoring client personnel, closing incident reports and resolving technical issues.
Responsible for preparing and executing commissioning, equipment, utilities and facility protocols (IQ/OQ/PQ) in injectable process validation.
Worked with laminar flow module, Budzar cooling/heating system, Nitrogen, WFI, Compress Air and Portable Tanks.
Associate.Senior Validation Engineer Resume
Headline : Senior Engineer with 20 years of experience in Process, Metrology, Facilities,Maintenance Management. Extensive validation experience in pharmaceutical equipment systems for GxP compliance. Strong background in critical systems such as: WFI, Clean Steam, Compressed Air, and HVAC. Seasoned in corrective preventive maintenance practices, process systems for operational support and compliance.
Skills : Aseptic Technique, Quality Auditing, Quality Systems Remediation, CAPA, Consent Decree Problem Solver.
Managed project based on assigned tasks and report project status and progress to home based Project Manager.
Performed reviews and gap analysis on executed deliverables such as Commissioning and IQ/OQ documents to validate aseptic equipment and aseptic processes.
Provided on-site quality control and proof of performance testing.
Responsible for preparing and executing protocols in compliance with cGMP's.
Developed project schedules for validation and execution scope.
Developed SOP's for the Packaging Inspection and EBR's for AML-14 building and Packaging Area on AML-1.
Followed up with QA contacts, Manufacture Operations and Packing Area & various Assessors.
Senior Validation Engineer III Resume
Headline : Accomplished Senior Validation Quality Engineering Consultant who has 30 years of software design control, verification and validation, software and quality engineering, supplier interface, product commercialization and IT project management experience for medical device, pharmaceutical, rail car, document imaging system, and software solution industries.
Skills : Analysis, Verification, Validation, And Certification Of Aircraft, Medical Device, And Military Life Critical Systems In FDA, FAA, And DoD Regulatory Environments., LabView Development.
Managed validation activities and resources for various capital projects.
Worked major pharmaceutical companies including Pfizer (Global R&D and Global Manufacturing) and Eli Lilly Drug Manufacturing.
Developed user requirements equipment specification documents for automated equipment following GAMP for Pfizer Global Manufacturing and Eli Lilly.
Developed and lead team responsible for executing temperature/relative humidity mapping of warehouses and environmental chambers.
Developed and implemented validation program for equipment and facilities used in the manufacture of clinical products in phase 3 for Pfizer - Michigan Pharmaceutical Sciences.
Developed and implemented templates for equipment/computer validation and facility qualification for Pfizer - Michigan Pharmaceutical Sciences (Clinical Sterile and Non-Sterile Manufacturing).
Supported implementation of validation program to train and qualify personnel at Pfizer- Michigan Pharmaceutical Sciences R&D Facility.
Bachelor In Chemical Engineering
Senior Validation Engineer Resume
Summary : BS Chemical Engineer with 20+ years of Engineering and Project Management experience in Pharmaceutical bulk API (Active Pharmaceutical Ingredient), aseptic liquid, gel, & solid dosage), Bio-Pharmaceutical, Pediatric Vaccine, Blood Fractionation (21 CFR 210 & 211), Medical Device (21 CFR 820) facilities and Environmental Remediation.
Skills : Microsoft Office, Saleslogix, Customer Relationship Management.
Followed Validation Policy and execute Validation Master Plan.
Performed equipment and process validations.
Maintained calibration and maintenance program scheduling and coordinate calibration maintenance activities required for GMP equipment/systems.
Oversaw validation and calibration activities performed contract service providers.
Performed IOQs of standard equipment (ex: controlled temperature units).
Assisted with writing, reviewing and executing FATs, SATs and IOQs for customized equipment.
Supervised calibration contract service providers.
Senior Validation Engineer I Resume
Objective : Manufacturing leader with over 10 years of experience and keen eye for business practices and record of success in bio pharmaceutical industry and within current Good Manufacturing Practice (GMP) environments. Works collaboratively across departments to successfully achieve goals and expectations.
Skills : Regulatory Environments, Root Cause Analysis.
Managed, maintained and operated all Compression technology in use at Network; and proactively monitor all inbound and outbound transport streams for errors via the NMX servers, logical maps, DBS analyzers, and visual confirmation.
Identified and document trends in service affecting outages.
Responsible for departmental requirements of on-air operations, and provide oversight.
Conducted daily test and monitor developmental or operational product, while troubleshooting problems and providing corrective action.
Worked with vendors involved in implementation process and track action items to ensure satisfactory levels of customer support.
Assisted Operations and Maintenance departments with solutions to on-air problems.
Reviewed system design documents, including single line drawings, cable schedules and equipment layouts.
(DeVry University - Phoenix, AZ)
Lead Senior Validation Engineer Resume
Headline : Quality Professional with MS in Quality Management and BS in Biology with extensive years of experience within Quality, QC, Manufacturing, Research/Development, Aseptic Techniques, Validation, Root Cause Analysis (CAPA) Process Improvement, Facilities (CAD), Technical Support arena with proven success in process improvement, Validation, Six Sigma, ISO 9000 and 13485, Project Management, Reformulations, Problem Solving, Auditing, Lean Manufacturing, Analytical Test Methods, and improving quality systems.
Skills : Process Validation, Cell Culture, Pegylation, UFDF,.
Managed Facilities and Utilities Validation: annual budget, capital expenditures (CapEx), equipment procurement, employee reviews, management of staff of seven including 6 validation engineers and 1 technician.
Supported manufacture of drug eluting stents (DES) and catheters.
Established and implement validation strategy for medical device cleanrooms.
Reviewed, writing and execution of Validation documentation for cleanroom facilities and utilities.
Used 6-Sigma statistical techniques to validate and improve production processes.
Wrote and signed-off CAPA after found the root cause and resolved the issues.
Performed routine maintenance on compression systems via logical and topographical mapping and through physical walkthroughs on a daily basis.
B.Sc. In Environmental Sciences
Senior Validation Engineer Resume
Objective : Experience in generating all validation documents, including validation plan, Gap Analysis, Remediation Plan, URS, FRS, FAT, PFMEA, Risk Assessment, Design Specifications, IQ, OQ, and PQ Test Protocols, Traceability Matrices, Test Method Validation, DOEs, Standard Operating Procedures (SOPs), and Validation Summary Reports.
Skills : Program / Project Management, Computer System Validation,.
Successfully implemented 90% of production assembly fixtures tooling for medical devices.
Developed new manufacturing processes, validation and verification methods.
Wrote and executed IQ/OQ/PQ test protocols and validation reports for respective medical devices.
Developed process limit settings for OQ test protocols by using DOE.
Worked with QA department with respect to Validation Master Plan to ensure project is aligned with original new product development specifications Supported and troubleshot new and existing manufacturing equipment and processes.
Transferred manufacturing to outsourcing vendors and then managed process improvement projects.
Redesigned and improved products by using Design for Manufacturing Assembly (DFMA) methodologies to reduce cost, waste, operator dependent.