Waleed Hindawi

Senior Quality/Validation Engineer Consultant, Johnson & Johnson Aug 2013 - Present


* Tracking, coordinating, and executing remediation activities per consent decree work plan.
* Supervising end-to-end packaging validation activities and reviewing/auditing packaging equipment qualification and validation documents.
* Leading validation execution and support to develop and qualify activities at contract packaging sites, including the transition to new validation SOPs.
* Serving as a Subject Matter Expert (SME) with respect to validation requirements for solid and liquid dosage packaging.
* Reviewing and auditing past qualification activities in support of future validations.
* Analyzing processes and multiple source documents to identify critical technical and compliance requirements.
* Developing and implementing enhanced packaging validation processes and procedures as well as providing technical inputs for strategic company guidelines and policies.
* Auditing and reviewing existing qualification documentation (IQ/OQ), confirming packaging equipment information to support development activities, and communicating company validation requirements.
* Assessing current documents against new standards, reviewing PQ and PPQ protocols and final reports, resolving related issues, and preparing completions reports.

Senior Quality/Validation Engineer Consultant, Terumo Cardiovascular Sep 2012 - Aug 2013


* Developed documents to remediate production and process controls for electro-mechanical surgical equipment and instruments to address FDA consent decree.
* Ensured all computer system work is executed as per corporate standards, master plan, practice documents, and other elements of the quality system.
* Created user requirements, System Configuration Specifications (SCS), and Traceability Matrix (TM) documents.
* Performed risk assessment, design review, testing, and FS/DS besides developing protocols, test plans, and scripts.
* Generated requirements documentation and equipment qualification protocols for non-automated manufacturing equipment and calibrated measuring devices.
* Executed process operational qualification protocols for pouch sealer machines.
* Conducted software quality assurance reviews to validate lifecycle documentation for various medical device product families.
* Conducted readiness/auditing review for existing completed validation documents to determine compliance with current procedures and regulation.

Senior Quality/Validation Engineer Consultant, Novartis/Sandoz Jan 2012 - Sep 2012


* Developed and executed dirty and clean hold time study cleaning validation protocols for pharmaceutical equipment, such as, bins, utensils, coating pans, granulators, roller compactors, fitzmills, etc.
* Well versed with swap recovery techniques. Created in-process information forms for detailed documentation of the manufacturing process.
* Developed and executed product hold time process validation protocols as well as process performance qualification protocols for various pharmaceutical solid dose products.
* Performed batch records reviews on a variety of products.

Senior Quality/Validation Engineer Consultant, Saint Jude Medical Corporation Sep 2011 - Jan 2012 | Mar 2010 - Mar 2011


* Conducted gap analysis and remediation activities for various medical device documents.
* Developed and executed cleaning validation protocol for implantable devices.
* Created PFMEA and master validation plans for NurseMate and Ensite velocity display workstations.
* Developed and executed process validation protocols, attributes, and variable test method validation.
* Trained and led team members to develop validation lifecycle documentation, including Equipment User Requirements (URS), Equipment Functional Design Specifications (FDS/FRS), DOE, attribute and variable test method validation, master validation plan, installation/operational/performance qualifications, and summary reports policies and procedures and template development.