Validation Engineer Resume Madison, NJ - Hire IT People

PROFESSIONAL SUMMARY:

5 years of experience in FDA regulated Pharmaceutical industry with concentration in Equipment Qualification, Computer System Validation, and Process Validation.
Implemented current industry best - practices for auditing and compliance to governmental regulations and guidelines such as FDA 21 CFR Part 11, 58, 210, 211; EU Annex 11, Annex 15; ASME BPE; ICH Q9, ICH Q10; GAMP 5; and cGMPs.
Applied Commissioning & Qualification (C&Q) and ASTM E2500 approaches for the Validation Life Cycle of various systems.
Validated Legacy Systems using GAP Analysis, Risk Management, and Change Control.
Working knowledge and extensive understanding of System Development Life Cycle (SDLC), Validation Life Cycle, Testing methodologies, Deployment, SOP’s, and Good Documentation Practices (GDPs).

TECHNICAL SKILLS:

Manufacturing/Lab: Bioreactors, Filtration Skids, Filter Integrity Testers, Kaye Validators, and Homogenizers.

Automated Systems: SCADA systems, Isolators, RABS, Vial Washers, Filling/Capping/Stoppering Machines, Data Acquisition Systems, PLCs, CIP & SIP stations.

Temperature Mapping: Warehouse, Autoclave, Chillers, Refrigerator, and Incubator.

Process Validation: Media Fills and Parenteral Drug.

Software: SAP ECC, HPQC ALM, Documentum, Maximo, Microsoft Visio, Microsoft Office.

PROFESSIONAL EXPERIENCE:

Confidential, Madison, NJ

Validation Engineer

Responsibilities:

Review and approve Data Mapping Documents.
Perform risk assessment of Data Objects and author risk-based Data Migration protocols for testing and production environments.
Perform Data Profiling of the source and target data files to identify and mitigate data issues.
Develop Work Instructions (WI) and conduct s.
Oversee thirty-seven (37) people from IT, Business, and Quality teams at different geographical locations to facilitate the Data Migration process.

Confidential, La Verne, CA

Validation Engineer

Responsibilities:

Authored and executed IQ/CQ/OQ protocols for PLC based SCADA systems associated with automated Data Acquisition systems and utilities systems using Commissioning & Qualification (C&Q) Approach.
Performed temperature mapping/qualification of Warehouse and Cold-Rooms.
Developed/revised system SOPs using Information Mapping techniques.
Applied Risk-Based Family Approach to qualify multiple Filter Integrity Testers and Kaye Validators.
Executed Spreadsheet Validation.
Developed System Impact Assessments, Component Criticality Assessments, and 21 CFR Part 11 Compliance Assessments for computerized systems.
Performed Job Hazard Analysis (JHA) and system P&ID walk-downs to support IQ of Utility Systems.
Coordinated with multiple departments and vendors to streamline validation activities.

Confidential, Lexington, KY

Validation Engineer

Responsibilities:

Validated Legacy Manufacturing Equipment using Gap Analysis and Risk Assessment methodologies.
Authored and executed IQ, OQ, and PQs protocols for Filling Machine, Filtration Skids, and Aseptic Isolators & RABS.
Executed Smoke Studies and VHP Decontamination studies for the aseptic primary packing line.
Wrote lifecycle documents such as URS/FRS/CS, performed supplier assessments and Design Qualifications (DQ).
Performed temperature mapping/qualification of Refrigerators, Chillers, and Autoclaves.
Qualified Kaye Validator - AVS thermal validation system using GAMP5 guidelines.
Participated in the execution of Media Fill Studies and Process Validation (PV) protocols.
Assisted department manager in development of Validation Plans for various systems in support of company’s expectation.

Confidential, Dayton, OH

Research Assistant

Responsibilities:

Validated Bioreactors and Mixers.
Performed Temperature Mapping and Mixing Process Improvement Studies of the Tanks.
Participated in the development of Clean In Place (CIP) and Steam In Place (SIP) Cycles for the tanks and their associated piping systems.
Performed Pilot Plant Scale-Ups of the Bioreactors.
Exercised judgment between using defined practices and company’s policies in selecting methods and techniques for addressing deviations and continuous improvement activities.
Participated in Commissioning activities, performed Risk Assessments, reviewed Factory Acceptance Tests (FATs), Site Acceptance Tests (SATs), and mixing equipment inspections in a Pilot Plant.

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Validation Engineer Resume

Madison, NJ

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