Arlene Simmons
Sacramento,CA
Summary
Accomplished CQV professional with over 30 years in the pharmaceutical and biotechnology sectors. Expertise in commissioning, qualification, and validation, complemented by project management and regulatory compliance, ensures high-quality, inspection-ready manufacturing environments.
Overview
12
12
years of professional experience
Work History
Senior CQV Engineer
Lonza
Vacaville, USA
01.2022 - Current
- Executed Installation Qualification (IQ/IOQ) and Computer System Validation (CSV) for Vi-CELL BLU Cell Viability Counter, ensuring compliance with GMP and internal validation requirements to maintain product integrity.
- Authored quality documentation for Project VV2030, including System Impact Assessments (SIA), Administration SOPs, Equipment Qualification and Computer System Validation (CSV) protocols, Vendor IOQ Summary Reports, User Requirements Specifications (URS), Data Audit Trail Assessments, Maintenance Strategies, Exception Report, Risk Record, and Data Lifecycle Flow Charts
- Coordinated QC equipment procurement by serving as liaison between vendors and client, managing shipping and receiving, onboarding Field Service Engineers (FSE), and supporting onsite vendor IOQ activities to streamline equipment readiness.
- Performed Supplier Quality Management activities, verifying approved vendor status, coordinating supplier qualification documentation, and facilitating new vendor approvals to ensure quality supply chain.
- Completed equipment categorization and classification in accordance with approved procedures and validation requirements
- Supported engineering design reviews by verifying chloride calculations, confirming Mechanical Bill of Materials (MBOM) accuracy against P&IDs, and updating GEMU component documentation.
- Provided Environmental Monitoring Performance Qualification (EMPQ) support during DARA PQ activities and during Operational Qualification (OQ) testing of automated doors in Building B9.
Senior CQV Specialist
Regeneron
Rensselaer, USA
01.2022 - Current
- Led validation engineering for Tempel Lane Project, managing validation scope, project schedules, cross-functional activities, and quality reviews of qualification documentation to ensure GMP compliance.
- Authored System Impact Assessments (SIA), Design Qualifications (DQ), Equipment Qualification Assessments (EQA), and Installation Qualification (IQ) protocols for critical GMP utility systems, ensuring effective operation of Water Pre-Treatment, Water for Injection (WFI) Generation, Clean Steam Generation, and Compressed Air Generation systems.
- Collaborated with cross-functional teams to support project initiatives.
- Analyzed data to identify trends and inform decision-making processes.
- Developed training materials for new staff onboarding and ongoing education.
CQV Specialist
Foundation for Biomedical Research and Innovation
Kobe, Japan
01.2022 - Current
- Authored and executed Installation and Operational Qualification (IOQ) protocols for Barkey Plasmatherm, Cell Saver 5+, SEPAX 2 Cell Processing, and Elutra Cell Separation systems to ensure compliance and operational readiness.
- Prepared Final Summary Reports (FSRs) and assembled validation packages, ensuring documentation accuracy and compliance with GMP and internal quality standards for audit readiness.
- Trained FBRI personnel on equipment qualification processes and GMP validation requirements, enhancing team knowledge and adherence to regulatory standards.
CQV Specialist
Applied Biosystems
Foster City, USA
01.2022 - Current
- Authored and executed Installation and Operational Qualification (IOQ) protocols for controlled temperature environments (CTEs) to ensure compliance and operational integrity of refrigerators, freezers, biosafety cabinets, laminar flow hoods, and shrink-wrap machines.
- Generated Final Summary Reports (FSRs) and compiled qualification packages to maintain accuracy and compliance, ensuring audit-readiness of validation documentation.
- Managed research protocols to ensure compliance with biomedical standards.
- Collaborated with cross-functional teams on innovative research projects.
- Developed training materials for new staff on laboratory procedures.
CQV Specialist
Theravance Biopharma
South San Francisco, USA
01.2022 - Current
- Prepared qualification documentation for process equipment including Buchi reactor/distillation systems, Nutsche-type filters, filter dryers, centrifuges, portable vessels, and vacuum tray dryers to ensure compliance with GMP standards and facilitate equipment qualification.
- Collaborated with researchers to support biomedical project execution.
- Assisted in developing protocols for experimental procedures and data collection.
- Coordinated with multidisciplinary teams to ensure project alignment and progress.
CQV Specialist
Aerojet Fine Chemicals
Rancho Cordova, USA
01.2019 - Current
- Authored and executed Installation and Operational Qualification (IOQ) protocols and generated Final Qualification Reports for process equipment, utilities, and facility systems, including reactors, filter dryers, vacuum pumps, solvent distribution systems, nitrogen, plant air, steam, USP water, breathing air systems, Temperature Control Units (TCUs), HVAC systems, and MultiColumn Chromatography (Varicol) systems.
- Authored Validation Plan and qualification protocols for IOQ activities in Building 05-111 and Filter-Dryer Building, facilitating compliance and operational readiness.
- Compiled Engineering Turnover Packages (ETOPs) for qualified systems, ensuring thorough and accurate documentation transfer that met project and GMP requirements.
Senior CQV Engineer
BioMarin
Novato, USA
01.2018 - Current
- Authored and executed Commissioning Test Plans (CTPs), Site Acceptance Test (SAT) protocols, Installation, Operational, and Performance Qualification (IOPQ) protocols, Verification Summary Reports (VSRs), Design Verification Test Matrices (DVTM), Test Matrices (TM), and Performance Qualification (PQ) protocols for new and modified equipment, systems, and facilities.
- Executed qualification activities for facility, utility, and process equipment, ensuring compliance with regulatory standards for ERGO Drum Lifters, Single-Use Bioreactors (SUBs), Verdot Chromatography Columns, Compressed Dry Air (CDA), O₂/N₂/CO₂ Gas Manifolds, Pure Steam, Water for Injection (WFI), and RO/DI water systems.
- Executed commissioning activities for Necropsy Tables, Lighting Control Systems, Lab Effluent Systems, Facility Fit & Finish, and Tempered Water Systems, contributing to operational readiness and safety standards.
- Authored and executed the Security System Commissioning Test Plan and Verification Summary Report for the Petaluma Research Project.
- Developed and authored qualification protocols and reports for CTEs including refrigerators, ultra-low temperature freezers, cold rooms, liquid nitrogen freezers, and incubators, supporting BioAnalytical Sciences, Quality Control, and Manufacturing operations across San Rafael and Novato, CA facilities, ensuring adherence to GMP requirements and validation procedures.
Validation Specialist II
Bayer Healthcare
Berkeley, USA
01.2018 - Current
- Executed qualification of Millipore Milli-Q Integral 15 Water Purification Systems, ensuring compliance with quality standards at Emeryville Station East (ESE) facility.
- Qualified Controlled Temperature Environments (CTEs) for the QC Stability (ESE) and Building 55 Freezer Farm facilities.
- Executed Cleaning Validation (CV) protocols for buffer tanks, product tanks, stockpots, filter housings, and miscellaneous process parts used in Aseptic and Non-Aseptic Processing Areas (APA/NAPA) within Building 49.
- Developed Commissioning Test Plans (CTPs) for autoclave, parts washer, biowaste, and waste neutralization systems supporting the CCTC project.
- Performed electronic execution of commissioning and qualification protocols using ValGenesis, ensuring compliance with GMP documentation requirements.
- Authored Site Test Verification Plans (STVPs), Process Development (PD) protocols for mixing and cleaning studies, and final summary reports; performed quality review of validation documentation to ensure accuracy and compliance.
- Executed Process Development (PD) studies for autoclave liquid load sterilization, tangential flow filtration (TFF) skid mixing, and chromatography skid in-line dilution processes.
- Authored decommissioning periodic review reports for qualified analytical and non-analytical laboratory equipment across Buildings 28A, 53, and 80, facilitating regulatory compliance for HVAC systems, biosafety cabinets, analytical instruments, and other CTEs.
CQV Specialist
Chiron Corporation
Vacaville, USA
01.2018 - Current
- Developed and executed Clean-In-Place (CIP) validation protocols for centrifuges, fermenters, and homogenizers to verify cleaning process effectiveness and compliance with established acceptance criteria.
- Authored and executed qualification protocols for GMP production equipment, ensuring compliance and operational readiness of glassware washers, depyrogenation ovens, media preparation/mixing systems, and buffer tank systems.
- Executed Cleaning Validation protocols for manual cleaning processes, verifying effectiveness and compliance of various process parts and equipment components.
- Supported process validation activities for client products by ensuring aseptic collection, handling, and aliquot of in-process samples into appropriate containers, and coordinating shipment to client laboratories within defined sampling timeframes for QC testing.
Microbiology Supervisor
Point Biomedical
San Carlos, USA
01.2015 - Current
- Established and supervised Quality Control (QC) Microbiology Laboratory, ensuring compliance and effective quality system activities to support laboratory operations.
- Developed and implemented laboratory procedures in alignment with current Quality System Regulations (QSRs), regulatory guidelines, and company quality standards.
- Developed and optimized environmental monitoring program for Point Biomedical San Jose facility, enhancing contamination control measures and maintaining regulatory compliance.
- Authored and reviewed standard operating procedures (SOPs) and QC test methods, aligning practices with company requirements and regulatory expectations.
QC Laboratory Associate II
Matrix Pharmaceutical
Fremont, USA
01.2015 - Current
- Executed viable and non-viable environmental monitoring and personnel monitoring activities in support of cGMP manufacturing operations; reviewed documentation for compliance with approved SOPs and quality requirements.
- Performed QC Microbiology testing activities, including Endotoxin testing (Kinetic Chromogenic assay), bioburden testing by membrane filtration, and microbial identification using the Biolog system.
- Performed environmental monitoring activities within aseptic processing areas and calibrated RCS air sampling equipment to ensure accurate contamination monitoring.
- Sampled and tested purified water systems for Total Organic Carbon (TOC) using Anatel instrumentation and conductivity to support water quality monitoring programs.
- Managed inventory and prepared microbiological media, including TSA settling/contact plates, SDA/RBA agar strips, and TSB broths, ensuring timely availability for routine monitoring activities.
- Generated deviation reports for out-of-specification (OOS) results and streamlined laboratory procedures to enhance environmental monitoring data entry, tracking, and trend analysis.
- Reviewed batch records and quality documentation, compiled lot packet summaries, and ensured compliance with regulatory and company quality standards.
Chemistry Technician 1
Consolidated Veterinary Diagnostics
Sacramento, USA
01.2015 - Current
- Executed clinical chemistry assays on automated analyzers, including hormone testing (cortisol, T3, progesterone) using radioimmunoassay (RIA) methods to support accurate patient diagnosis.
- Conducted coagulation testing, routine urinalysis, and stool and stone specimen analysis, ensuring precise and timely reporting of results to aid in effective patient management.
- Conducted routine chemical analyses for veterinary diagnostics.
- Maintained laboratory equipment to ensure optimal performance.
- Prepared samples for testing using standard operating procedures.
Laboratory Assistant, R&D
Baxter Diagnostics – Microscan Division
Sacramento, USA
01.2015 - Current
- Conducted antibiotic bioassays to determine antimicrobial potency and support product quality evaluation.
- Managed daily inventory and viability of fresh microorganisms, ensuring compliance with laboratory operations and quality control standards.
- Conducted moisture analysis on dried panels during dryer validation studies, accurately documenting results to support research objectives.
- Facilitated pilot plant manufacturing runs by coordinating production and freezing of panels, preparing pH buffers and fluorogenic concentrates, and performing wet-read analyses.
- Performed quality assurance testing on production and refurbished WalkAway and AS4 instrumentation to verify equipment performance and reliability.
Laboratory Assistant, Clinical Pathology and Histology
Genentech inc
South San Francisco, USA
01.2015 - Current
- Processed, embedded, mounted, and stained histology specimens according to laboratory protocols to support diagnostic evaluation.
- Executed histology laboratory operations, including slide archiving, preventive maintenance of staining equipment, and management of laboratory supply inventory to ensure seamless workflow.
- Assisted in preparing laboratory samples for experiments and testing.
- Maintained laboratory equipment and ensured proper functioning.
- Documented experimental procedures and maintained accurate records.
Education
B.S. - Medical Technology
University of Santo Tomas
PhilippinesSkills
- Process Validation
- Process Equipment Qualification
- Performance Qualification
- Cleaning Validation
- Computer System Validation
- Utility qualification
- Controlled temperature environment qualification
- Laboratory Equipment Qualification
- Room Qualification
Locations
- Vacaville, Vacaville, CA, 95688
- Novato, Novato, CA, 94945
- Berkeley, Berkeley, CA, 94704
- Rensselaer, Rensselaer, NY, 12144
- Kobe, Kobe, Japan
- Foster City, Foster City, CA, 94404
- South San Francisco, South San Francisco, CA, 94080
- Rancho Cordova, Rancho Cordova, CA, 95670
- San Carlos, San Carlos, CA, 94070
- Fremont, Fremont, CA, 94536
- Sacramento, Sacramento, CA, 95814
Continuing Education
- CAI training: Tier 1, Tier 2
- Veeva Quality Docs Document Management
- Cybersecurity Training
- Security Basics Training
- Gowning Training
Timeline
Senior CQV Engineer
Lonza
01.2022 - Current
Senior CQV Specialist
Regeneron
01.2022 - Current
CQV Specialist
Foundation for Biomedical Research and Innovation
01.2022 - Current
CQV Specialist
Applied Biosystems
01.2022 - Current
CQV Specialist
Theravance Biopharma
01.2022 - Current
CQV Specialist
Aerojet Fine Chemicals
01.2019 - Current
Senior CQV Engineer
BioMarin
01.2018 - Current
Validation Specialist II
Bayer Healthcare
01.2018 - Current
CQV Specialist
Chiron Corporation
01.2018 - Current
Microbiology Supervisor
Point Biomedical
01.2015 - Current
QC Laboratory Associate II
Matrix Pharmaceutical
01.2015 - Current
Chemistry Technician 1
Consolidated Veterinary Diagnostics
01.2015 - Current
Laboratory Assistant, R&D
Baxter Diagnostics – Microscan Division
01.2015 - Current
Laboratory Assistant, Clinical Pathology and Histology
Genentech inc
01.2015 - Current
B.S. - Medical Technology
University of Santo Tomas