Gerald Jacques Email & Phone Number

United States

Rahway, New Jersey, US

• Collaborated with cross-functional teams to troubleshoot and resolve validation issues, enhancing efficiency.
• Developed and optimized validation protocols for new and existing equipment to ensure compliance with industry standards.
• Authored and executed Change Control documents in adherence to Regulatory GMP requirements.
• Documented validation activities and results in detailed reports for regulatory audits.

Irvine, CA, US

• Reviewed and approved supplier PPAPs to ensure quality standards were met.
• Conducted root cause analysis to implement corrections for non-conformities related to supplied components.
• Developed inspections and test methods to verify product conformance and improve Supplier Quality system performance.

Bloomington, Indiana, US

• Applied accurate TMV standards to legacy products to adhere to EUMDR requirements.
• Authored and executed a full suite of validation documentation which included: Installation / Operational / Performance Qualification (IQ/OQ/PQ) and Test Method Validation (TMV) Protocols, Summary Reports.
• Generated Computer System Validation (CSV) Functional and Configuration Specifications to ensure that the User Requirements are met and documented in Traceability Matrixes.
• Collaborated to support the validation of new metrology equipment introduction to obtain variable measurement data.
• Lead a cross-functional team to prioritize/delegate remediation activities, and escalated issues pertaining to the project schedule for resolution.
• Facilitated risk-based remediation activities through the application of statistical methods to create, develop, and validate test methods.

St Petersburg, Florida, US

• 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/delegate remediation activities and escalated issues pertaining to the project schedule for resolution.
• Collaborated with cross-functional teams to strategically structure change controls to support new process/equipment introduction.
• Authored and executed a full suite of validation documentation which included: Validation Plans, User Requirement Specifications, Functional Requirements, Factory Acceptance Test (FAT), GR&R, Installation / Operational.
• Conducted tests to verify that the specifications were met, and key manufacturing parameters fell within predetermined acceptance criteria tolerances.
• Applied statistical methods to create, develop, remediate, and validate test methods.

Kalamazoo, MI, US

• Collected, cleaned, and prepared data from various sources in order to conduct a deep analysis used for data-based decision making.
• Served as Data Analyst focused on getting the right data presented in an actionable way to key decision makers allowing them to drive towards business goals and be more effective.
• Developed and maintained analytical dashboards with visualizations and reports to track key performance indicators and provide insights to stakeholders.
• Benchmarked and tracked process changes against key operational performance indicators.
• Created reports, dashboards, and visualizations that effectively communicated data insights to internal stakeholders, including executives, and various cross-functional teams.
• Conducted data mining, regression, and quantitative analysis while maintaining data documentation for both internal and external consumption.

Kalamazoo, MI, US

• Supported the development and introduction of new orthopedic products by working extensively with Product Development, Metrology, Quality, and Operations to take a product from design concept through production ramp up.
• Responsible for validating Test Methods (TMV) to ensure quality, reliability, and consistency.
• Developed, coordinated, and conducted technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE)
• Utilized Minitab to conduct Measurement System Analysis (MSA) or Gauge R&R to assess total %Study Variation
• Managed new equipment installation and inspection activities with the metrology team.
• Create and release QMS documentation and Preventive Maintenance schedule for multiple equipment including CNC milling, Bead Blast, Laser engraving, Coordinate Measuring Machine (CMM), Robotic Tending, and Furnaces.

• 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.
• Execute IQ/OQ/PQ and Test Method Validation (TMV) protocols and characterization studies, summarize data, and write-up report drafts.
• 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, in order to resolve spikes in NCRs and improved the manufacturing process flow.
• Planned, identified and performed quantitative risk analysis as needed to facilitate the development and completion of risk file documentation.

Parsippany, New Jersey, US

• Croll Reynolds Company is an engineering firm specializing in the research, design, and manufacture of process equipment
• Developed and managed teams capable of executing performance in adherence of Quality System procedures.
• Managed project knowledge and 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 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.

• Syntonic Corporation distributes and installs renewable energy components and turnkey solutions for residential, municipal, and commercial applications.
• Conducted system sizing and predictive modeling for PV systems using PVsyst, taking into account shading and pitch effects on projected annual energy production.
• Applied value engineering methods on the design of systems by using prewired harnesses, direct bury armored cables, and aluminum wires for cost savings on labor and materials.
• Managed two third-party engineering firms to complete drawings for final issue of design deliverables.
• Oversaw projects throughout the development phase obtaining various permits from government agencies and utilities.
• Liaised with clients, subcontractors, and project managers throughout all phases of the projects.

Kingsville, TX, US

• 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
• Responsible for assisting in the design of experiments used in the Chemical Engineering undergraduate curriculum.
• Implemented pilot scale unit operations and associated PLC control systems such as Liquid Level, Temperature, and Pressure control systems.

• Corpus Christi Infusion Center is an outpatient facility which provides 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 company’s 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