Mervyn Pinto
Carmel,IN
Summary
Versatile professional with over a decade of experience in the pharmaceutical and IT sectors, driving operational excellence, ensuring regulatory compliance, and delivering measurable outcomes. Effective leader and a problem solver with a consistent track record of enhancing efficiency and instigating durable transformations through inventive strategies and process optimizations. In leadership positions in Validation, Quality Assurance, and IT has ingrained a unique insight that propels performance. This is complemented by a zeal for relentless knowledge acquisition and adaptability, alongside a collaborative strategy for resolving issues.
Overview
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1
Certification
Work History
Sr. Manager
GxP Systems, Moderna Therapeutics
- Led cross-functional digital team to achieve project milestones, deliver high-quality results; implemented Covid 19 testing lab in 2020, surpassing quality and timeline requirements, delivering lab in record time for increased testing volume due to Covid 19 requirements.
- Implemented innovative solutions to overcome challenges, enhancing productivity levels, managing large scale projects, introducing new systems, tools, and processes to achieve state-of-the-art lab 4x size of existing lab.
- Collaborated closely with peers from other departments to drive organizational success as one cohesive unit, steering Data Integrity CAPAs, deviations, and proactive initiatives to closure in anticipation of external Audits.
- Mentored junior staff for skill development and career progression within organization.
- Met or exceeded annual performance targets set by senior leadership.
- Achieved operational excellence by streamlining processes, implementing best practices.
- Improved team performance by providing comprehensive training, fostering collaborative work environment.
- Ensured compliance for global laboratory and quality systems used for commercial testing as Digital Lead for Data Integrity initiative, planned feasibility of move accounting for DI and business continuity.
Sr. QA and Data Integrity Engineer
Anika Therapeutics
- Oversaw comprehensive Gap assessment of Anika's over 25 Legacy Quality Control systems, pinpointing opportunities for enhancement.
- Formulated and executed strategic, cost-effective remediation plans to address identified deficiencies.
- Directed establishment of configuration, backup, and restore protocols, as well as Audit Trail processes, leveraging automated solutions and manual procedures to bridge gaps effectively.
- Ensured meticulous documentation of all remediation measures to maintain stringent adherence to regulatory standards and support ongoing system maintenance and upgrades.
Sr. QAV and Data Integrity Engineer
Vedanta Biosciences
- Minimized inventory management inefficiencies through detailed inspections and pinpointing improvement opportunities; led the implementation of SAP Business One to bolster inventory management and cut analyst time spent on paper-based systems by half.
- Established robust Computer System Validation policy framework, including creation of standard operating procedures (SOPs) and templates to streamline compliance processes.
- Conducted process and system audits to identify areas of improvement, enforce compliance with industry standards, introducing ComplianceWire Learning Management System as site LMS.
- Prevented costly quality shortcomings by proactively addressing potential risks before escalation into larger issues, introducing and incorporating Einfotree to bolster spreadsheet governance.
Sr. QA Data Integrity Specialist
Ipsen Bioscience
- Played pivotal role in cross-departmental collaboration aimed at upholding data integrity throughout data lifecycle for over 40 Lab and quality systems.
- Detected critical data integrity challenges, instrumental in devising strategic solutions to rectify issues, enhancing internal methodologies.
- Contributed to crafting of procedures that ensure preservation of high-quality data, consistent processes across organization.
- Took lead in initiating, evaluating pertinent change controls, quality incident probes, CAPAs, diligently monitoring advancements, ensuring comprehensive gap remediation to satisfy stringent criteria.
- Proactively surfaced, advocated for process optimization prospects.
Senior Verification and Validation Engineer
The RND Group
- Achieved successful project outcomes by maintaining accurate documentation, meeting strict deadlines for 10x Genomics Chromium Connect application and NeuMoDx application.
- Improved team productivity by providing technical guidance, mentoring junior engineers during software verification phase.
- Conducted rigorous quality assurance tests, identifying areas of improvement for product optimization.
Manager of Quality Assurance Validation
Shire
- Led and coordinated project teams, securing fulfillment of project aims with defined expectations and specs, focusing on systems like Empower3, RapID, TOC-M9, DXR Smart Raman, and Handheld Raman Spectrometer.
- Managed project lifecycle to meet project needs.
- Collaborated with cross-functional SME/management to delineate project boundaries and deliverables.
- Crafted and adhered to detailed project timeline, ensuring diligent monitoring, communication of developments, and alignment with project goals.
- Engaged multiple departments for planning to have adequate project support.
- Partnered with Information Technology to guarantee timely completion of Infrastructure Qualification and proper resource distribution to sustain project's validation lifecycle.
- Ensured consistent communication and nurtured relationships with both functional and cross-functional team members, fostering project commitment, and keeping all key parties—such as affected departments, system owners, and stakeholders—informed about project particulars.
Senior Validation Engineer
Shire
- Streamlined equipment qualification procedures for increased efficiency and reduced downtime.
- Conducted thorough root cause analyses to identify and resolve recurring issues in validation lifecycle.
- Validated analytical equipment in compliance with FDA, USP 1058 and Annex 11 regulations.
- Optimized validation schedules by prioritizing critical projects based on business needs and resource availability.
- Actively participated in policy making discussions and helped process development for Analytical Equipment Qualification.
- Assisted in vendor selection for lab instruments based on their Quality Management System and Supplier Assessment Questionnaire.
- Developed Validation Project Plans, Validation Protocols (IQ, OQ and PQ) and Validation Summary Reports in accordance with FDA and Annex 11 regulations.
- Owned change controls, remediation plans and change actions for implementation of lab systems.
Validation Engineer
Shire
- Conducted validation of analytical equipment, ensuring adherence to FDA, USP1058, and Annex 11 guidelines, and assessed vendor protocols to confirm compliance with international regulations.
- Ensured regulatory compliance with FDA guidelines by conducting thorough validations and maintaining accurate documentation.
- Improved validation processes by developing and implementing risk-based strategies for equipment, systems, and facilities.
- Collaborated with cross-functional teams to resolve complex issues, resulting in reduced downtime and increased production output.
Validation Engineer
TEVA Pharmaceuticals
- Prepared and executed validation lifecycle document for equipment used in manufacture of Metamucil done in accordance with to FDA, MHRA and EU regulations.
- Authored validation master plan for water treatment system used for agglomeration and other purposes.
- Evaluated the current procedures for CIP and SIP and implementing methods for improving cleaning and sanitization process of equipment.
- Wrote summary report for validation lifecycle.
Cleaning Validation Engineer
Janssen Pharmaceutical
- Reduced costs by identifying inefficiencies in operations and implementing cost-saving measures.
- Established and optimized cleaning procedures for equipment involved in Doxil production including process qualification and documentation.
- Authored validation protocols for lab equipment, enhanced sample collection methods, and collaborated with SMEs to refine cleaning and validation protocols.
- Updated SOPs for cleaning processes, particularly for vessels with spray-balls, and conducted cycle development to ensure effective spray-ball operation at low pressures.
- Developed strong client relationships through consistent communication and attentive service.
Lab Analyst
University of Texas
- Improved lab efficiency by streamlining sample processing and data analysis procedures.
- Enhanced quality control measures for increased accuracy in test results and reporting.
- Trained new team members on laboratory techniques, equipment usage, and safety protocols to maintain a high level of productivity.
Production Support Analyst
TCS E-Serve
- Collaborated with the analytics and support services department to troubleshoot PC issues and assist with software updates.
Intern
Sakav Ovens Dryers and Furnaces
- Contributed to positive team environment by collaborating with fellow interns on group projects and presentations.
- Worked on manufacturing and testing 1% relative humidity sensor for relative humidity measurement for commercial Oven Dryers and Furnaces.
Education
Master of Science - Biomedical Engineering
The University of Texas At Arlington
Arlington, TXBachelor of Science - Instrumentation And Process Control
Vidyavardhini's College Of Eng. And Tech.
Mumbai, IndiaSkills
- Leadership in Quality Assurance and Validation: Enthusiastic leader with expertise in Quality Assurance, Computer System Validation, and Data Integrity Implementation Skilled at propelling operational excellence, enhancing efficiency, and increasing profitability Recognized for comprehensive understanding of validation lifecycle, from budgeting and forecasting through execution and approval, with unwavering commitment to compliance and precision
- Validation Lifecycle Management: Skilled in designing and managing critical validation lifecycle documents, ensuring compliance and operational success in qualifying enterprise computer systems and various analytical equipment
- Audit Expertise: Extensive experience in conducting internal and external audits, ensuring adherence to regulatory standards and drive process enhancements based on audit outcomes
- Six Sigma and Continuous Improvement: Certified Six Sigma Green Belt with robust knowledge in quality engineering disciplines, employing lean methodologies to champion continuous improvement and sustainable change
- Communication and Stakeholder Engagement: Possess strong communication skills, adept at building relationships with diverse stakeholders, tailor management styles to individual needs, and nurture team success through proficient leadership and communication
- Regulatory Knowledge and Cloud Solutions: Thorough understanding of FDA regulations, including 21 CFR Part 11, 21 CFR Part 210 & 211, complemented by demonstrated proficiency in cloud solutions like AWS for application hosting, data archival, and ensuring regulatory compliance, with unwavering focus on data integrity and security
- Team Development and Leadership: Committed to motivating teams for self-development and career ownership, fostering presentation and communication skills alongside technical expertise Leadership approach is to encourage success through empathy, work-life balance, and effective collaboration
Certification
- Lean Six Sigma, Green Belt - GBMP, The Northeast Lean Conference (Moderna)
Timeline
Sr. Manager
GxP Systems, Moderna Therapeutics
Sr. QA and Data Integrity Engineer
Anika Therapeutics
Sr. QAV and Data Integrity Engineer
Vedanta Biosciences
Sr. QA Data Integrity Specialist
Ipsen Bioscience
Senior Verification and Validation Engineer
The RND Group
Manager of Quality Assurance Validation
Shire
Senior Validation Engineer
Shire
Validation Engineer
Shire
Validation Engineer
TEVA Pharmaceuticals
Cleaning Validation Engineer
Janssen Pharmaceutical
Lab Analyst
University of Texas
Production Support Analyst
TCS E-Serve
Intern
Sakav Ovens Dryers and Furnaces
Master of Science - Biomedical Engineering
The University of Texas At Arlington
Bachelor of Science - Instrumentation And Process Control
Vidyavardhini's College Of Eng. And Tech.
- Lean Six Sigma, Green Belt - GBMP, The Northeast Lean Conference (Moderna)
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