Alexander Aguirre
Rowville
Summary
Experienced professional in Commissioning Qualification & Validation, with a Microbiology, Quality and Compliance background, and 24 years of expertise in the Biotech and Pharmaceutical Manufacturing Industry. Sterile, non-sterile (solid Dose) and biological process manufacturing.
Expertise in Sterilization/Sterile Manufacturing/Sterility Assurance. Steam-in-Place (SIP), and sterilization theory and application. Process bulk manufacturing, Clean in Place (CIP), product mixing qualification. Expertise in sterilization techniques, sterile filtration and implementation. Autoclave, facility HVAC and utilities qualification and validation.
Overview
24
24
years of professional experience
Work History
Project Manager
CSL Behring
03.2024 - Current
- Site Expansion Project: Project managing and execution of Commissioning and Qualification of Process Filling Equipment, Utilities, HVAC, Automated Vision Inspection systems.
- Filling lines (syringe and bottle), document generation, execution and report generation Established effective communication among team members for enhanced collaboration and successful project completion.
- Provided detailed project status updates to stakeholders and executive management. Mentored junior team members in qualification best practices to enhance their skills and contribute to better overall performance.
- Coordinated with cross-functional teams to resolve project issues and mitigate risks.
- Demonstrated respect, friendliness and willingness to help wherever needed.
- Monitored progress against established goals, adjusting schedules and resources as needed to keep projects on track.
Validation Manager - Engineering and Facilities
Moderna Inc
10.2023 - 03.2024
- Organising equipment commission qualification and validation for all equipment delivered to Moderna’s facility during site construction
- Liaising with Global counterparts and stake holders to unify one approach to qualification activities while implementing and facilitating access to 2 new EDMS systems to contractors
- Approval of User Requirement Specifications
- Coordinating the first stages of contractor responsibilities and cost during construction. Assessments and classification of manufacturing rooms and quantification of sampling requirements, equipment, and consumables cost estimates
- Planning qualification of single use systems for Drug Substance manufacturing of Nano Lipid -encapsulation, purification, formulation to filling of vials and prefilled syringes to packaging and serialisation of finished packs
- Developed and maintained courteous and effective working relationships.
Senior Quality and Validation Specialist
CSL RnD and Innovation Headquarters
01.2021 - 10.2023
- Introduction and execution of Validation Master Plans for CSL’s RnD Gloveless Filling Isolator
- CIP Skids commissioning and qualification
- Qualification of vial inspection units, manual and automated, and a new CCIT unit
- Disinfectant efficacy qualification for filling facility
- Reviewed and Approved User Requirement Specifications (URS), IQs and OQs.
- Executing and approving Design Qualifications (DQs), and Requirement Traceability Matrices (RTMs).
- Performed Quality Risk Assessments, FMEAs.
- Coordinating and working with project teams to deliver and meet major milestones
- Execution Review, and approval of Validation approach protocols, adherence to industry regulatory Requirements TGA/ FDA/ 21 CFR Part 11 and EU GMP Annex 15.
- Reviewer/Approver of vendor documentation as per project URS requirements
- Collaborated with cross-functional teams for identification and resolution of validation issues.
- Developed comprehensive validation master plans to ensure alignment across all projects and stakeholders.
- Fostered a culture of continuous improvement by actively seeking feedback from team members, implementing process enhancements based on lessons learned.
- Prepared detailed qualification documents including IQ/OQ/PQ protocols and reports for equipment and systems within regulated environments.
Validation Site Lead
Glaxo Smithkline
01.2015 - 12.2020
- Writing/Approving Site Validation Master Plans
- Responsible for all Validation activities carried out comply to relevant site GMP and OHS&E requirements
- Validation batch release: Site planning and logistics coordination. Maintaining site resource allocation for site’s re-qualification and validation reviews as per VMP schedule.
- Training, and mentoring of validation staff, engineering graduates in the advanced future leader program
- Compliance team member and assessor for site QMS/TGA/Specific market requirements, Approving Product Manufacturing Dossiers
- Change control panel approver
- Team Resources management of contractors for CSV and validation projects
- Managing CAPA Validation actions to meet deadlines and final implementation dates
- Reviewing and approving of regulatory Product Dossiers for Market registrations.
- Fronting internal and external auditors and implementing actions derived from inspections and preparing Audit responses
- Monitored inventory levels, ordering supplies as needed to minimize downtime due to shortages.
- Promoted a culture of continuous learning by offering professional development opportunities to team members regularly.
- Developed effective communication channels between onsite teams and offsite management staff.
- Trained new team members on site policies and procedures.
- Supervised material usage and contractor man-hours to keep projects in line with budgetary restrictions.
- Improved employee morale through consistent leadership support, fostering a positive working environment conducive to productivity.
- Oversaw equipment maintenance routines regularly ensuring optimal performance levels across all machinery used for validation purposes.
- Developed comprehensive site equipment requalification schedules to optimize resources and minimize downtime.
Senior Validation Specialist
Glaxo Smithkline
03.2011 - 01.2015
- Validation of Major/Minor production process projects
- Coordination of validation of new products (Injectable and solid dose)
- Lead Investigations and risk mitigation for batch deviations as a facilitator for Production Managers and Staff for Root Cause Analysis and Failure Mode (RCA 6 step facilitator).
- Validation Lead for Stage 2 of GSKs Boronia site Expansion Project
- Regulatory Submission writing and/approving of product registration dossiers for supply to new and existing markets
- Monitored and reported on test results and performance data to identify areas of opportunity for improvement. Collaborated with cross-functional teams for identification and resolution of validation issues.
- Proposed development and testing improvements to positively impact usability, function and performance.
- Provided technical expertise on industry best practices, contributing to continuous improvement initiatives within the organization.
- Implemented effective change management strategies during equipment modifications or upgrades, ensuring smooth transitions with minimal impact on operations.
- Conducted comprehensive risk assessments to prioritize validation efforts and maximize resource utilization. Assisted in the preparation of audit materials, demonstrating full compliance with internal policies and external regulations during inspections.
- Streamlined standard operating procedures for consistent results and increased productivity.
- Collaborated with engineering teams to optimize equipment design for ease of validation and operational excellence.
- Strengthened communication skills through regular interactions with others.
Validation Microbiologist/Bacteriologist
Glaxo Smithkline
01.2010 - 01.2011
- Coordinating the Testing of Non-sterile and sterile products
- Maintenance of in-house bacteria culture collection
- Coordinating the Validation of new testing methods for the introduction of new Pharmaceutical Products
- Authorization of sterile and non-sterile product release
- Completing Continuous Improvement Projects within the Laboratory
- Update of in-house SOPs and Procedure according to current GMP/PICS codes
- GMP /GLP checker of tests performed in the Laboratory
- Interpreted research findings and summarized data into reports.
Validation and Risk Specialist
Glaxo Smithkline
01.2007 - 01.2010
- Qualification and Validation of Major/Minor CAPEX/OPEX projects
- Validation of APIs changes and product format changes
- Execution of Periodic Product product, equipment and (PPRs), Validation Reviews: product, equipment and computerized systems
- Implementation of Operational Excellence (OE), and lean sigma principles
- Principal lead in a Kaizen exercise with the site’s validation, production, QA/QC, teams.
Education
Associate of Applied Science - Forensic Science/ Microbiology
Swinburne University of Technology
Melbourne, VIC03.2001
Skills
- Process Development
- Product Testing
- Equipment Qualification
- Clinical Manufacturing
- Microbiology/Analytical Method Validation
- Operational Excellence/Lean Manufacturing
- Audit SME
- Technical Report Writing
- CAPA Management,
- User Requirements Specifications (URS)
- Design Qualification, Installation Qualification, Operational Qualification
- Performance Qualification
- Change Control, Product Tech Transfer Validation
- QMS and Regulatory Compliance, Internal and external supplier qualification- ISO 13485/9001 Auditing
- GLP/GMP/GCP/GDP Compliance
Steam in Place (SIP), Dry Heat Sterilization
- VPHP Decontamination, EtO Sterilization, Autoclave Sterilization
- E-Beam Decontamination
- Non Sterile Manufacturing Qualification and Validation of Blending and Mixing Equipment, Tablet Press, Coating
- mRNA Vaccine process & filling qualification and validation
- Single Use Process Equipment/Ready to Use Components
- CCIT Equipment method validation
Biological Equipment Process Validation
- Bioreactor, Chromatography Skids, Buffer Tanks, TFF
- HVAC Qualification, and Utilities Qualification Validation
- Cleaning Validation (CIP)
- Continuous Improvement and Lean Sigma experience - Green Belt Certification, Root Cause Analysis, Deviation Investigation
- Project Strategic Planning
Contractor and Staff Management - Project resource allocation
- Coaching and Mentoring of Staff
Accomplishments
- Implemented and refined product co
- Presented with GSKs President's Award for AU/PAC Manufacturing and Supply Region for Continuous Improvement 2018
- Standardised validation protocols for routine validation and requalification activities resulting in document generation, execution and report approvals.
- Successfully led the relocation and revalidation of autoclave, and facility repurposing of the area for the introduction of new packing line and serialisation system and product palletiser.
- Part of of Australian project team as the validation lead for product transfers in collaboration with global sites.
- Initiated and completed a continuous improvement project to increase capacity in Sterile filling, Revised and optimised SIP sequences resulting in 5% increase in production yield.
- Consolidation of primary and secondary packaging, new pack art work, and finished product presentation for introduction of new products.
- Operational Excellence and Lean Sigma and Continuous Improvement (CI) projects:
- Site Utilities; Water Testing reduction for Operational Excellence Greenbelt Project savings achieved 75K per year.
- Validation Project Lead for the introduction of GSKs Rotarix Vaccine in a Nebule presentation qualified and developed filling parameters using BFS technology.
- Validation Lead for Stage 2 Expansion Project Building and facility for product process manufacturing, filling, and packing inspection.
- Validation Technical Support Lead for the Regulatory submission and registration dossiers for supply to new and existing markets.
- Lead the implementation of new shipping containers for Rotarix vaccine transport routes, packaging configuration, new insulated container (Australian and International Supply Chain). Achieving Significant reductions in Cold Chain Supply deviations by 40%
- Project Validation Lead for CSL Melbourne.
- Total savings of $600.000/year
- Reduction in filling/packing change overs efficiency improvement of 35%
- OEE improvements in key products 58%
- Implementation of Operational Excellence (OE), and lean sigma principles. Lead and collaborated in a Kaizen exercise with the site’s validation , production, QA/QC, teams achieved outcomes
- Identified minor and major CI projects
- Defined Value streams
- Implementation of 5S in production QA/QC areas.
- Developed standard ways of working.
- Implemented DEMAIC system (visual boards) to measure, analyze data in real time to control, and act on encountered issues.
- Qualification of two containment Cell Culture Isolators for processing Chinese Hamster Ovarian Cells (CHO) and harvesting.
- Chromatography, Bioreactor and Buffer preparation Equipment qualification
- Validation of a gloveless Robotic Filling Line
- Cycle Development and qualification the Vapour Phase Hydrogen Peroxide (VPHP) cycle parameters for the filling isolator.
Profileskills
Facility, Utilities, and Equipment Validation of sterile and non-sterile process manufacturing., Experienced in fronting regulatory inspections as an SME for TGA/FDA/EMA/ANVISA., Internal L1/L2 GMP Auditor., Sterilization theory and practical methods., Cleaning validation (CIP), vessels, packing lines for solid dose., Lean Sigma and Operational Excellence principles and practices.
Keywords
- Process Development
- Product Testing
- Equipment Qualification
- Regulatory Guidelines
- Clinical Manufacturing
- Analytical Method Validation
- Lean Manufacturing
- Audits
- Technical Reports
- CAPA Management
- Pharmaceutical Sample Management
Soccer, Music, Drums, Latin Percussion.
Enjoy playing and coaching Soccer
I really enjoy playing the Drums and Timbales to unwind.
Languages
Spanish
Native or Bilingual
Portuguese
Professional Working
Italian
Limited Working
Timeline
Project Manager
CSL Behring
03.2024 - Current
Validation Manager - Engineering and Facilities
Moderna Inc
10.2023 - 03.2024
Senior Quality and Validation Specialist
CSL RnD and Innovation Headquarters
01.2021 - 10.2023
Validation Site Lead
Glaxo Smithkline
01.2015 - 12.2020
Senior Validation Specialist
Glaxo Smithkline
03.2011 - 01.2015
Validation Microbiologist/Bacteriologist
Glaxo Smithkline
01.2010 - 01.2011
Validation and Risk Specialist
Glaxo Smithkline
01.2007 - 01.2010
Associate of Applied Science - Forensic Science/ Microbiology
Swinburne University of Technology
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