Principal, Design Assurance Quality Engineer + 15 years of experience Resume
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Resume:
WENDY DELGADO
voice mail
SUMMARY OF QUALIFICATIONS
Strong quality assurance /validation background coupled with excellent communication and project management skills. Experience in biologics, biopharmaceutical, active pharmaceutical ingredient (API), solid dosage, and medical device industries. Areas of expertise include: validation of automated equipment and systems such as, BMS, PLC and DCS and software validation including CFR Part , process validation, utilities, sterilization, and engineering. Experienced with CFR , , , . This includes preparation/execution of Master Plans, Software Risk Analysis, Gap Analysis, Validation Protocols, PS/PDP, PRS/SRS, FAT, SAT , Risk Management (PHA, HA, FMEA, RMP & RMR), DHF, MDR, Standard Operating Procedures, Change Control, CAPA, Re-qualification and Preventive Maintenance Programs for utilities and systems used in these industries. Assess quality systems for QSR, EN/ISO , ISO , EN ISO /collaterals and regulatory compliance MDD, AIMDD, R-PAL and other quality standards/regulations. Proficiency in written and spoken Spanish
PROFESSIONAL EXPERIENCE
CAREFUSION, Corp., Yorba Linda, CA –
Principal, Design Assurance Quality Engineer
- Ensure compliance of Quality and system processes including: design control, design assurance, product risk management and V&V activities for new development and legacy products.
- Manage input and output project deliverables were on schedule and provide support to engineering during the development of DHF.
- Perform project (DHF) audits to ensure compliance of product development activities/deliverables to site quality standards. Assigned corrective actions to individuals based on audit results prior to design phase.
- Provide assistance in the investigation/correction of design failures/challenges and facilitate required corrective/preventive actions.
- Support multiple projects at varying Life Cycle stages. Participate in Product Life Cycle Phase Reviews.
- Review and approve product specification, verification, data analysis, testing evaluation, validation, aging studies, DV build plans, process validation, product labels/packaging, engineering drawings, DHF, technical file, and document control for consumables, hardware and software changes.
- Ensure effective V&V efforts and their supporting documentation are in compliance with applicable regulation and standards.
- Established and improve product/process quality individually and through team based problem solving efforts.
- Lead activities as an input to product Risk Management activities; plans, hazard analysis and DFMEA / PFMECA with core team and generation of documents for new development and legacy products.
- Lead in annual and bi-annual Notified Bodies audits of each QMS. Participated in routine FDA audits and non-regulatory agencies as well. Manage the stage “War” room, review documents and coach auditee during audits. Assist Regulatory Affairs with submissions and documentation.
- Collaborate with Supplier Quality group and assist in audits as needed.
- Trained and lead training sessions for personnel in response to a corporate audit finding. Identified and evaluate personnel files were out of compliance and required to be trained per QMS.
- Collaborate with personnel and upper management to implement training compliance as required per job function.
- Manage local calibration Management System.
MEDTRONIC DIABETES, INC., Northridge, CA –
Principal SW Quality Engineer, Lead
World leader manufacturer of insulin pumps and continue glucose monitoring devices.
- Managed staff of engineers to ensure Software product releases during development were tested accordingly prior to its final intended use software.
- Verification and validation testing of medical devices & network systems. Hands-on product analysis through direct testing, design reviews, risk analysis and other best engineering practices.
- Team resource for designing to standards, guidance’s, and technical file requirements.
- Responsible for providing quality-engineering support for product development//legacy projects, technical support, procedure generation and auditing.
- Conducted FMEAs, risk analysis and other technical reviews of product design.
- Managed projects internationally to achieve successfully and to strongly demonstrate compliance with Japan Regulatory agencies (PMDA & MHLW) for approval of Manufacturing Site Accreditation (MSA) of OEM and vendors from US, Mexico, Puerto Rico and Denmark.
- Collaborate with Supplier Quality group and assist in audits as needed.
- Implement a quality system and become an expert as a source for designing to standards, guidance, and technical file requirements with FDA, MDD, AIMDD, R-PAL, and other standards.
- Actively involved in internal as well as FDA and EU NB audit processes.
- Participate in Product Life Cycle Phase Reviews initial concept, design and final product realization.
- Provide input to compliance team for quarterly management review. Present data as needed.
- Feasibilities studies in-house, clinically approved sites domestic and international, reviewed and approved documentation for FDA submission.
- Demonstrated strengths in achieving business goals anticipating the customers’ questions (cross-functional and cross geography teams) and demands as well as meeting tight schedules, deadlines and handling shifting priorities effectively.
AMGEN, INC., Thousand Oaks, CA –
Senior Validation Consultant – Owner Consulting Inc.
Validation and Consulting services throughout Southern California
- Execution and generation of final reports for medium steam sterilization and sterilization of fermentors, autoclaves and incubators. Generation of technical writing documents for commercial product – automation system such as Asea-Brown-Boveri (ABB) DCS for EtO and L fermentor systems.
- Project management of utility system and equipment such as: HVAC, RO/DI, Compressed Air, and Dust Collection.
- Generation of technical writing documents using standard procedures, CFR and compliance with cGMP requirements to an upgraded facility for manufacturing of Clinical Phase solid dosage formulations of small molecule products.
BIOGEN IDEC, Oceanside, CA –
Senior Validation Consultant – Owner Consulting Inc.
Building Management System (BMS) , I/O Siemens (DCS) at the Biogen Idec, NIMO Facility. This is a newly constructed facility, which includes the following buildings; Lab Office, Warehouse, Administration, Utilities and , sq/ft Bulk Protein Manufacturing NIMO building.
- Project Leader duties included: Assigning and tracking work for (client and independent contractors) personnel. Reviewed FAT, SAT and protocols documentation for quality. Train BMS team and other validation-consulting contractors on Insight Siemens Automation software. Approved, reviewed and mentored Siemens ( –) personnel with GMP and validation related issues in various capacities throughout the project.
- Interactions with Biogen Idec upper management, third-party vendors and lead personnel to oversee the validation effort as it relates to the BMS.
- Review for technical accuracy and generate analysis of documents such as Validation Master Plan, Software Risk Analysis, Critical Component, SDD, HDD, FRS, FAT and SAT ensuring adherence to Biogen Idec policies as they apply to the software development life cycle (SDLC) methodologies and compliance practices ensuring with CFR Parts , , and , GaMP and cGMP.
- Advised and generated necessary documentation for upcoming Regulatory and non-regulatory Agencies inspection and attended update meetings.
ALLERGAN INC., Irvine, CA
Senior Validation Consultant – Owner Consulting Inc.
Generate FAT documentation for an Anaerobic Isolator features a self-contained Incubator. The isolator provides a controlled environment for the growth and proliferation of C. botulinum. The isolation protects from external microbial contamination in a BL laboratory facility. Accountable for IQ/OQ/PQ writing, execution and final report generation of the Anaerobic Isolator unit.
- Protocol development IQ/OQ of a -Liter Fermentor Control System that consist of four () fermentors that communicates with other Biologics Support Facility PLCs, and SCADA server via Ethernet network system to the BL laboratory for cell purification and fermentation.
- Generated IQ/OQ protocol and final report for Utility Control System – WFI, Clean Steam, Compressed Gases, Processed Water and Chilled Water. Equipment included Allen-Bradley PLCs, Intellution HMI, RSLogix, process transmitters, valves, and local controllers, monitoring equipment and associated with SCADA control system.
BAXTER BIOSCIENCE, Los Angeles, CA -
Senior Validation Consultant – Owner Consulting Inc.
BAXTER BIOSCIENCE, Los Angeles, CA –
Senior Quality Engineer
Worked in a research, development, and manufacturing facility for blood plasma products.
- Led the restructure of the Requalification Program equipment related with sterilization for parenterals products. Generated SOPs, FEMA Risk Analysis, GAP Analysis, CAPA, ER, final reports, exception reports and train personnel involved with all aspects of the process. Lead duties included: assigning and tracking work for direct reports. Review and approve technicians’ re-qualification and sterilization documentation.
- Manage internal and external audits and generate audit response, monitored corrective action follow-up and commitments to Domestic and International Regulatory Agencies.
- Accountable for the integration of Software Engineering practices as they apply to the software development life cycle (SDLC), Software Quality Assurance (SQA) methodologies and compliance practices ensuring with CFR Electronic Records/Electronic Signatures (ER/ES).
- Responsible for protocol generation for computerized systems in the Aseptic Filling Area such as: client/server application, design, development, implementation, data base design testing for PLC/SCADA (WonderWare ™ Intouch ® and SQL), enterprise-wide system for BAS system DCS (Siemens) factory floor automation.
- Provide technical guidance to Phase . Aseptic Filling team. Development of protocol generation and project management of equipment and systems such as: HVAC system, Capper/Laser/Vision system, Tray Loader system.
- Participate on a shutdown project Lyophilizer control system (Allen-Bradley PLC & visualization software WonderWare ™ Intouch ®) Validation Master Plan and IQ and OQ protocol generation.
VALICOR ASSOCIATES, INC., Corona, CA –
Validation Specialist II
Pharmaceutical contract validation services throughout the United States.
- Various assignments for interacting with the client to document the equipment or system, protocol writing, protocol execution including field measurements and final report writing including conclusions and exception reporting.
- Project management of equipment such as: Tablet Press, Fluid Bed Processor, Clean Steam Generator, Encapsulator, Lyophilization CIP/SIP Systems, Homogenizer, Transfer Pump, Syringe Packaging unit, Syringe Assembly unit, Leak Detector Tester, Bonder LCD Overlay, Electronic Module Tester, Bushing Staking Tool, UV Curing System, Process Heat Exchanger, Microfluidizer, Mixing Vessels, Parts Washer, Autoclave, Reactor Systems, Chemical Refrigerator, Rotavapors, Distillation Columns, Molecular Still, Heat Exchanger, Evaporator System, Storage, Dilution and Horizontal Tanks, Blender Unit and Packaging unit, Freezers, Cold Rooms, and PLC control systems.
- Project management of utility systems such as: HVAC, WFI, Clean Steam, Nitrogen, Compressed Air, Purified Water Systems, Portable Clean Room Systems, Lighting and Electrostatic Discharge.
- Technical writing of systems description, purpose, testing and documentation using standard procedures and forms customized to the clients’ equipment or system.
- Professional meetings clients discussing progress and scheduling. Anticipating the clients’ questions and demands as well as meeting deadlines.
Validation Engineer II, PHARMACEUTICAL SERVICES CORP., Glendale, CA
Validation Engineer, ALPHA THERAPEUTIC CORP., Los Angeles, CA –
EDUCATION AND CERTIFICATIONS
BS, Chemical Engineering, California State University, Long Beach
HVAC System Engineering, California State University, Long Beach - Certification
Six Sigma Engineer – Baxter in-house Certification
PROFESSIONAL DEVELOPMENT
MDD & AIMDD, R-PAL, ISO, IEC, CE, labeling, sterilization, other standards and guidelines
FMEA & FTA for medical devices and Bio-Pharmaceutical industries
Risk Management for Medical Device and Bio-Pharmaceutical industries
Advance Computerized Systems Validation including SDLC approach
Various companies’ GLP and GMP training per industry requirements
SECURITY BACKGROUND
Federal Bureau of Investigation (FBI) – BL and BL Clearance on file
Drug Enforcement Agency (DEA) – E Clearance Control Substances on file
Department of Defense (DOD) – Top Secret Clearance on file
ADDITIONAL DEVELOPMENT & CERTIFICATIONS
- Worked in clean rooms ranging from Class K to K room environments.
- Aseptic Clean Room Gowning Certified – Baxter BioScience
- Performed airflow pattern studies for filling suites and re-qualification.
- Highly experienced on sampling for viable and non-viable particles for compressed gas systems.
- Exceptionally experienced on environmental monitoring test for non-viable, viable air, viable surface (aerobes and anaerobes) and sterility assurance sampling. Temperature mapping using biological indicators (strip or suspension), for moist steam and dry heat systems.
- Proficient with, MS Word, MS Excel, MS Access, Power Point, MS Project, Kaye Validator and Validator Software.
- Proficient with Insight Siemens DCS Automation software.
- Proficient with Asea-Brown-Boveri (ABB) DCS Automation software
PROFESSIONAL AFFILIATIONS
American Society for Quality, ASQ – Senior Member
Orange County Regulatory Affairs, OCRA
International Society for Pharmaceutical Engineering, ISPE
Parenteral Drug Association, PDA
