Mattieu Claude
Hatboro
Summary
Detail-oriented CQV/CSV Engineer skilled in process and computer system validation. Known for strong problem-solving abilities and effective cross-functional collaboration, consistently achieving successful project outcomes and enhancing client relationships.
Overview
6
6
years of professional experience
Work History
Lead CSV Engineer
CAI - Celltrion
03.2025 - Current
- Developed lifecycle documentation in Kneat, including trace matrices and summary reports, for purification area automation system and downstream purification process system.
- Led client-focused design reviews, pinpointing and resolving testing scope deficiencies prior to validation execution.
- Authored and Executed Installation and Operational Verification test cases in Kneat validating automation changes to Purification Area MES through simulated and field testing, including two new automated process modes.
- Authored and Executed Installation and Operational Verification test cases in Kneat to validate automation changes to phases and recipes for Purification Chromatography Skid Systems.
- Collaborated with automation engineers and CSQA to resolve discrepancies and identify corrective actions, including functional specification changes and software updates, to adhere to operational specifications.
- Supported project management efforts by preparing status reports and updating stakeholders on progress.
- Improved client satisfaction with detailed progress reports and proactive communication during project execution phases.
Commissioning Engineer
CAI - Spark Therapeutics
01.2025 - 07.2025
- Develop commissioning pre-functional and functional performance checklists for critical and non-critical utilities, HVAC systems, and building security systems for Cell Gene Therapy Center.
- Conducted comprehensive P&ID walk-downs for building utilities, HVAC systems, and architectural finishes.
- Facilitated start-up processes for HVAC, boiler, and chiller systems.
- Verified construction documentation to meet client requirements for a complete and accurate TOP.
- Supported project timelines by coordinating with vendors and contractors effectively.
- Provided detailed progress reports on commissioning activities to keep stakeholders informed throughout the project lifecycle.
Validation Engineer
CAI - Catalent Pharma Solutions
04.2023 - 08.2023
- Authored and executed Installation and Operational Qualification protocols for cell and gene therapy process equipment including Class II Biological Safety Cabinets, Peristaltic Pumps, PCR System, Tube Sealers, and Rotators.
- Authored comprehensive protocols to ensure successful installation and operational qualification of upgraded clean compressed air distribution system.
- Authored Component Level Risk Assessment and System Impact Assessment for facility Clean Compressed Air Distribution.
- Engaged with vendors to assess and obtain all missing documentation essential for the comprehensive completion of the turnover package.
CSV Engineer
CAI - Celltrion
08.2022 - 03.2025
- Developed comprehensive lifecycle documents, including trace matrices, component impact assessments, and summary reports for buffer preparation and purification tanks, chromatography skid systems, air handlers, cold rooms, and system utilities within Kneat.
- Facilitated design review sessions with clients to enhance testing scope and ensure comprehensive verification strategy.
- Authored and executed Installation and Operational Qualification protocols for upstream & downstream processing equipment, air handlers, temperature controlled rooms, and system utilities.
- Executed temperature mapping for controlled classified environments and cold storage rooms.
- Executed and redlined P&ID walkdowns for system equipment and utilities.
- Documented discrepancies in Kneat during execution, coordinating with validation and QA to ensure timely resolution through functional specification adjustments, equipment repair, and software modifications.
- Mentored junior engineers, providing guidance on best practices and fostering a collaborative work environment.
- Established strong working relationships with clients through exceptional communication skills, fostering trust and collaboration.
Validation Engineer
CAI - SP, Scientific Products
04.2022 - 08.2022
- Authored detailed technical documents to ensure compliance for aseptic manufacturing equipment, encompassing SOPs, user requirements, functional specifications, trace matrices, site and factory acceptance tests, and I/O lists.
- Reviewed and adjusted styles and formatting in documents and templates to ensure adherence to client specifications.
- Engaged with project manager to coordinate efforts for the successful and timely execution of project deliverables within established project budget.
Analyst
Stursberg & Fine
08.2020 - 03.2022
- Developed and delivered an investment pitch for acquisition of $7MM manufactured housing community, securing $4.25MM in debt financing and $3.2MM in equity from investors.
- Developed underwriting models utilizing Excel to analyze historical and projected cash flows for over 50 properties.
- Conducted market research on the subject property and assisted with the due diligence process for over 30 transactions.
- Assisted senior analyst through the loan process from initial kick-off to closing and assisted with post-closing servicing representing 20 refinances, 2 acquisitions, and generating $45MM in financing to clients.
Education
Master of Science - Integrated Biomedical Engineering & Business
Drexel University
Philadelphia, PA06-2022
Bachelor of Science - Biomedical Engineering
Drexel University
Philadelphia, PA06-2020
Skills
- Time Management
- Critical Thinking
- Project Management
- Equipment Qualification
- Process Validation
- Computer system Validation
- GAMP 5 knowledge
- GxP
Affiliations
- International Society of Pharmaceutical Engineers – Member of Delaware Valley Chapter
Timeline
Lead CSV Engineer
CAI - Celltrion
03.2025 - Current
Commissioning Engineer
CAI - Spark Therapeutics
01.2025 - 07.2025
Validation Engineer
CAI - Catalent Pharma Solutions
04.2023 - 08.2023
CSV Engineer
CAI - Celltrion
08.2022 - 03.2025
Validation Engineer
CAI - SP, Scientific Products
04.2022 - 08.2022
Analyst
Stursberg & Fine
08.2020 - 03.2022
Master of Science - Integrated Biomedical Engineering & Business
Drexel University
Bachelor of Science - Biomedical Engineering
Drexel University