| Candidate Information | | Title | Project Management Chemical Engineer | | Target Location | US-NJ-Rahway |
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Click here or scroll down to respond to this candidateSUMMARYExperienced Validation Engineer with over 10 years in the Pharmaceutical, Medical Device, and Life Sciences industries. Proven expertise in equipment qualification, validation protocol preparation, and project management. Skilled in leading cross-functional teams to ensure compliance with cGMP, FDA, and ISPE guidelines. Dedicated to driving quality and efficiency in validation processes, with a strong focus on meeting client needs in adherence to industry standards.TECHNICAL PROFILEProject Management, Change Management, Technology Transfer, Continuous ImprovementCleaning Validation, Autoclaves, Aseptic Processing, Parts Washers, Equipment Qualification, PLC Diagnostics, PID Loop Performance Testing, Validation ProtocolsAuthored and executed a full suite of validation documentation which included: Validation Plans, User Requirement Specifications, Functional Requirements, Factory Acceptance Test (FAT), Installation / Operational / Performance Qualification (IQ/OQ/PQ) and Test Method Validation (TMV) Protocols, Trace Matrix, Summary Reports. root cause analysis, Risk Mitigation, CAPA, and Design of Experiment (DOE)Knowledge of Regulatory GXP requirements, FDA Guidelines, ISO13485, and Quality Systems (cGMP).Advanced Microsoft Excel skills for Statistical Process Control (SPC), financial analysis and reporting.Data analytics and visualization using tools like Power BI and Tableau.Agile Project Management Certification.Software: Microsoft Office Suites, Microsoft Visio, Microsoft Project, Minitab, AutoCAD, Solid Works, SQL, Agile QMS, SmartSheet.PROFESSIONAL EXPERIENCEValidation Engineer, Automation (Contract) Merck Pharmaceuticals, Rahway NJ(January 2024 to August 2024)Worked in the certification of cleanrooms and the qualification of Environmental Monitoring Systems (EMS).Served as a Validation SME for a Cleanroom validation project.Developed and optimized validation protocols for new and existing equipment, ensuring compliance with industry standards and regulatory requirements.Collaborated with cross-functional teams to troubleshoot and resolve issues during the validation process, reducing downtime and improving efficiency.Created and executed Building Management System (BMS) and Environmental Monitoring System (EMS) qualification documents which included Installation/Operational Qualification (IQ/OQ).Authored and executed Change Control documents in adherence to Regulatory GMP requirements.Documented all validation activities and results in detailed reports, providing comprehensive records for regulatory audits and inspections.Sr. Supplier Quality Engineer (Contract) Edwards Life Sciences, Draper UT(August 2023 to January 2024)Worked in the life science medical device division with flagship products which include transcatheter heart valves, and surgical valve technologies.Review and approve supplier PPAPs (Production Part Approval Process).Assess the Supplier Management, QA Management system and SOPs for continual improvement opportunities.Collaborated to support the Computer System Validation (CSV) of new metrology routines to obtain accurate variable measurement data.Sustained quality engineering within Receiving Inspection, Manufacturing, and Product Verification as applied to supplier related issues.Conducted root cause analysis and investigations to implement corrections for non-conformities related to supplied components.Track metrics related to non- conformity incidents. Monitor, evaluate, report, and improve Supplier Quality system performance while providing technical support to suppliers.Developed inspections and test methods (including writing and executing protocols) to verify supplied product conformance.Identified and implemented statistical engineering tools and techniques to evaluate supplier process capability and technical performance.Collected and analyzed quality metrics relating to Supplier Quality.Facilitated risk-based remediation activities through the application of statistical methods to develop and validate test methods.Supported supplier quality vendor management, audits, and improvements while contributing to continued Quality System improvements.Communicated Supplier Quality risks to upper management while suggesting improvements and cost savings where possible.Sr. Lead Test Method Validation Engineer, Manufacturing (Contract) Cook Medical, Bloomington IN (September 2022 to February 2023)Worked in the medical device division with flagship products which include catheters, needles, and wire guides.Applied appropriate TMV standards to legacy products in adherence to EUMDR requirements.Collaborated to support the Computer System Validation (CSV) of new metrology equipment introduction to better obtain accurate variable measurement data.Lead a cross-functional team where remediation activities were prioritized/delegated; and when necessary, escalated issues for resolution pertaining to maintaining the project schedule.Facilitated risk-based remediation activities through the application of statistical methods to develop and validate test methods.Maintained consistent communication with stakeholders on changes in priority, status, and timelines.Reviewed and approved validation protocols and reports.Developed and approved robust sampling plans for execution during validation activities.Provided support for internal and external audits and Quality System investigations.Sr. Validation Engineer, Manufacturing (Contract) Jabil Inc., Monument CO(January 2022 to September 2022)Worked in the Medical Devices, life sciences, department doing equipment validations for CNC machines associated with the production of Class 3 medical devices.Managed relationships with stakeholders while facilitating new equipment inspection and installation activities to deliver work on schedule and budget.Lead meetings with the core team to prioritize then delegate equipment validation activities and, when necessary, escalated issues pertaining to the project schedule for resolution.Collaborated with cross-functional teams to strategically structure change controls in the support of new process/equipment introduction.Conducted tests to verify that the specifications were met, and key manufacturing parameters fell within predetermined acceptance criteria tolerances.Drove continuous improvement of the manufacturing process, which included reporting metrics, and progression of key milestones.Sr. Validation Engineer Data Analyst, Advanced Operations (Contract) Stryker, Mahwah NJ(January 2020 to December 2021)Worked at Stryker Orthopedics in validations associated with the manufacture of joint replacement solutions which offer market-leading implants for the hip, knee, ankle, and shoulder.Contributed to the development and introduction of new orthopedic products by collaborating with cross- functional teams, which included: Product Development, Metrology, Quality, and Operations to take a product from design concept through production ramp up.Served as the Validation SME in Clean Environment Room (CER) project. Created Building Management System (BMS) qualification documents which included Preventive Maintenance schedules.Streamlined data validation procedures through the use of SPC, resulting in a 80% reduction in validation cycle time, saving an average of 100 hours per week.Utilized Minitab to conduct Measurement System Analysis (MSA) and Gage Repeatability and Reproducibility (GR&R) to assess total %Study Variation with the metrology team.Created and released electronic Quality Management System (QMS) documentation for multiple equipment including CNC milling, Bead Blast, Laser engraving, Coordinate Measuring Machine (CMM), Robotic Tending, Furnaces, and HVAC systems.Drafted Standard Operating Procedures (SOPs) for the operation of new equipment and coordinated necessary training activities.Developed and maintained turnkey analytical dashboards with visualizations and reports, in Power BI and Excel, to track key performance indicators and provide data insights to internal stakeholders, including executives, and various cross-functional teams.Benchmarked and tracked process changes against key operational performance indicators.Conducted data mining, regression, and quantitative analysis while maintaining data documentation for both internal and external consumption.Developed metrics and conducted analysis for measuring impact of decisions on Key Performance Indicators (KPI).Provided input on design of experiments that appropriately measured impact of process variables.Sr. Process Quality Engineer (Contract)- Validation Consulting Inc, Irvine CA(April 2018 to April 2019)Validation Consulting, Inc. is a resource solutions provider for industry-leading biotechnology, medical device, and pharmaceutical companies.Interfaced with cross-functional internal and external stakeholders on quality related matters. Liaised with contract manufacturing organizations to manage quality control schedules.Planned, managed, and controlled Test Method Validations (TMVs) ensuring that various methods were suitable for intended use.Conducted tests to verify that specifications were adhered to, and tolerances of key manufacturing parameters fell within predetermined acceptance criteria.Conducted quantitative root cause analysis to identify corrective and preventative actions, and resolved spikes in NCRs which improved the manufacturing process flow.Identified, planned, and performed quantitative risk analysis as needed to facilitate the development and completion of risk file documentation.Compiled technical data, analyzed key parameters, and drafted technical reports on quality findings.Participated In Failure Modes Effects Analysis (FMEA) and conducted Risk-based decision making in the successful resolution of issues.Lead technical presentations to communicate quality findings, and project updates to internal stakeholders.Setup SOPs and Runbooks for technical review and final signoffs from relevant stakeholders.Followed change request procedures to modify project scope.Process Quality Engineer Croll Reynolds, Parsippany NJ(April 2014 to April 2018)Croll Reynolds Company is an engineering firm specializing in the research, design, and manufacture of process equipment.Developed and managed teams capable of adherence to Quality System procedures.Managed technical documents such as drawings, Production and Process Control Procedures, Inspection Plans, etc.Planned, managed, and monitored communications to ensure that scrubber systems were fabricated in accordance with manufacturing prints.Developed and planned schedules with defined deadlines and sequenced activities based on estimated activity durations.Planned risk responses such that specifications were adhered to, and tolerances of key manufacturing parameters fell within predetermined stakeholder acceptance criteria.Streamlined design process to increase the right the first-time percentage (RTFT%).Liaised with fabrication and component vendors to reduce lead times and meet deadlines.Consulted with and completed projects for DOW, BASF, Johnson & Johnson, Evonik, PCS Phosphates and more.Project Engineer I - Syntonic Corporation, Morris Plains NJ(June 2013 to April 2014)Worked with this renewable energy firm specializing in the design and installation of residential and commercial use solar and wind systems with both on and off-grid capabilities.Planned and scheduled engineering efforts associated with completing assigned projects.Ensured accuracy and completeness of both verbal and written technical communication of assigned activities.Drafted and completed Final Reports including technical drawings for the installation of turbines.Performed field evaluations utilizing decision-making skills to determine feasibility of turbine installations.Coordinated cross-functional team efforts to achieve project performance within financial projections and regulatory compliance.Managed stakeholder engagement through scheduled communications related to project deadlines and the execution of procurements.Actively monitored project control work and performed integrated change controls.Assessed human, financial, and equipment resource requirements while securing stakeholder approval.Defined overall budgets and efficiently managed costs, achieving monthly financial and unit goals.Developed execution plans and master schedules to address project goals and milestones.Laboratory Technician - Texas A&M University, Kingsville TX(September 2011 to May 2013)Texas A&M University Department of Engineering is ranked amongst the top engineering schools in the nation.Oversaw proper operation and maintenance of pilot scale unit operations including a scrubber, batch enzyme reactor, constant pressure filtration system, heat exchanger, and both tray and packed bed distillation columns.Ensured accuracy of data through calibration of measurement systems such as Nuclear Magnetic Resonance (NMR), Infrared (IR), Gas Chromatography (GC), and PLC Controllers.Increased experiment efficiency by authoring well-defined laboratory experiment procedures.Pharmacy Lab Tech C.C. Infusion Center, Corpus Christi TX(August 2008 to September 2011)Worked with outpatient facility which provided medium- and long-term infusion services for ambulatory patients.Utilized basic knowledge of Six Sigma Methodologies to lead efforts aimed at the identification of problematic situations, the reporting of issues, and the development of resolutions and decision making.Know and follow all laws and policies that apply to distributing medical devices and providing quality care.Prepared weekly and quarterly budget reports mapping the companys fiscal status and overall progress.Implemented Quality System improvements to meet compliance and overall business goals.Reduced overall cost of antibiotics by 43% by implementing the installation of cleanroom which included a Laminar Airflow Hood (LAH) which met Class 100 (ISO 5) clean bench standards for IV admixture preparation.EDUCATIONB.S. Chemical Engineering, Minor: MathematicsMagna Cum LaudeTexas A&M University- Kingsville TXGPA: 3.74ACTIVITIES & AFFILIATIONSOmega Chi Epsilon Honors Society: TreasurerSPE Engineers: Vice PresidentEngineering Student Council: TreasurerSPE ACTE Conference San AntonioGolden Key International Honor SocietyAmerican Institute of Chemical EngineersASGMT Annual Conference Houston |
