SHAWN GARNER
Media
Summary
Strategic, data-driven leader with over 13 years of experience at Johnson & Johnson/Kenvue, specializing in comprehensive supply chain excellence and external manufacturing. Expert in aligning regional MAKE strategies with business objectives (OGSM) across Self-Care franchise. Demonstrated success in managing intricate portfolios, enhancing financial performance, and guiding cross-functional teams to mitigate risk and optimize resource allocation within global manufacturing network.
Overview
24
24
years of professional experience
Work History
Senior Process Specialist - External Manufacturing
Johnson and Johnson/Kenvue
7050 Camp Hill Road
09.2024 - Current
- Drive the execution of multiple projects within strategic programs to achieve clear and impactful business results.
- Collaborated with department leaders to establish strategies and programs across departments, integrating them within external sites' strategies and objectives.
- Continually assessed the performance of multiple sites across the external manufacturing network, recognized gaps to standards and implemented actions to resolve.
- Identified project risks, execution issues, and opportunities; developed risk mitigation and contingency plans by engaging teams in balanced debate and leveraging risk management expertise.
- Developed project schedules, identified cross functional deliverables and detailed timelines, and managed project priorities and cross project dependencies.
- Worked with business leaders and project leaders to ensure program and site goals were achieved. Held teams and site leaders accountable to business process standards.
- Managed site needs, including supporting ERP onboarding, overseeing project budgets, creating purchase requisitions, facilitating site change controls, and supporting Quality Assurance with site investigations.
Site Lead, External Manufacturing
Johnson & Johnson
Fort Washington
12.2022 - Current
- Developed and executed manufacturing strategies aimed at improving site performance.
- Ensured long- and short-term capacity aligned with supply forecasts and schedules.
- Identified and executed cost improvement projects (CIPs) that optimized resource allocation.
- Led cross-functional teams to resolve issues and enhance operational efficiency.
- Reviewed and approved quality documentation, ensuring compliance with industry standards.
- Collaborated with Quality groups to uphold compliance and quality standards.
- Coordinated new product launches to meet customer commitments for product availability.
- Participated in EM network strategies, leading complex projects across multiple regions.
Senior External Manufacturing Investigator
Johnson & Johnson
Fort Washington
01.2013 - Current
- Synchronize with external suppliers and manufacturers to address deviations across 11 contract manufacturing sites.
- Conduct extensive investigations to identify root causes and associated risks.
- Coordinated with quality assurance, technical and non-technical operations, engineering, mechanical maintenance, calibration, safety, and supplier quality management to define scope and implement corrective actions.
- Recommended preventative measures to reduce frequency of deviations in collaboration with quality assurance and technical operations.
- Introduce new quality management systems, such as Symphony ETQ, and Trackwise to track status and remain up-to-date with new developments.
- Facilitated internal GMP audits and authored change controls to streamline departmental processes.
- Improved product quality and customer satisfaction by reducing 160 open deviations in the system with a minimum of 40% overdue to 35 open investigations (two extended and 33 closed on time) in 45 days.
- Reduced number of open investigations to five and headed micro-project to monitor historical projects every quarter: maximized efficiencies and achieved 45 SKUs on reduced testing.
- Executed proactive mitigation strategies and corrective actions to preserve product integrity and maintain strong business relationships.
Audit and Validation Specialist, Consent Decrees
Pharma Bio Serve
Fort Washington
09.2012 - 01.2013
- Administered GDP/GMP compliance for Consent Decree Project documentation.
- Coordinated audit outcomes communication with governance bodies.
- Managed validation processes, drafted procedures, and ensured cleanability to prevent cross-contamination.
- Designed and implemented SOPs for downstream flow booths, coaters, and granulators.
- Earned recognition from peers and executives for expertise in FDA quality systems.
- Built record-setting team, fostering collaboration and professional development.
- Led quality management system implementation for client engagements, including business development.
Senior Operations and Manufacturing Supervisor
Merck & CO. Inc.
West Point
01.2007 - 01.2012
- Achieved significant cost savings and increased vaccine production by streamlining first shift operations and communicating identified issues to second shift teams.
- Supervised manufacturing operations for MMR, enhancing productivity by leading a team of eight professionals.
- Directed FDA licensure efforts by stocking testing equipment and mentoring validation team, ensuring compliance with QA protocols.
- Developed and implemented team schedules to align with project deadlines and support business objectives.
- Monitored suppliers by assessing quality, timeliness, and compliance with deliveries to control costs and maximize operational efficiency.
- Improved organizational effectiveness by compiling business requirements and optimizing data models and reporting frameworks.
- Designed and executed robust SOPs and internal policies to maintain efficiency and responsiveness per capital funding requests of $200K from project approval to project closeout.
- Attained $300K savings in building budget by facilitating the department in coordinating design phases for new sterile goods supply facility.
Viral Vaccine Engineer
Pro-Staff
South Amboy
01.2004 - 01.2007
- Adjusted processing schedules and production orders to optimize inventory management, staffing, and duty assignments within budget and time constraints.
- Maintained accurate document database by following confidentiality protocols to protect vital data.
- Resolved qualification and cleaning validation execution issues through critical analysis, ensuring compliance and operational integrity.
- Developed and implemented new SOPs for BHT parts and tank washers, Fedegari autoclaves, and dry heat ovens to enhance operational consistency and safety.
- Prepared and reviewed comprehensive cleaning validation protocols and reports, coordinated room and equipment documentation collection, and executed protocols.
Lead Process Engineer, Pilot Plant
Philadelphia Water Department
Philadelphia
01.2002 - 01.2004
- Led operations of drinking water pilot plant, managing team of 12 water technology assistants and two junior engineers to ensure efficient plant functionality.
- Presented analysis of research findings and innovations to 12-member panel, applying sanitary engineering principles to develop models, diagrams, charts, and schematics.
- Enhanced process efficiencies by 50% by identifying challenges with process units/equipment and implementing cost-effective solutions.
Medic, Medical Dept.
United State Army Reserves
Fort Dix
- Maintained medical records of 500 incoming soldiers.
- Trained 25 EMTs in life support skills.
- Administered tests and medication to stabilize patients.
- Conducted equipment and vehicle checks to maintain continuous and safe operation.
Project Engineer, Measles, Mumps, Rubella (MMR)
Pro-Staff
South Amboy
- Directed cross-functional team in developing project schedules and monitored metrics to evaluate team performance and results.
- Collaborated with company executives and project managers to acquire required resources.
Plastic Additives Engineer
Atofina Chemicals
King of Prussia
- Trained 10 technicians in four weeks, on the digital Torque Rheometer, heat distortion tester, and industrial press while ensuring strict compliance with safety standards and efficiency procedures.
Lab Technician
Garlock Valves and Industrial Plastics
Camden
- Maintained inventory and reordered before supplies diminished.
- Tracked and collected specimens by initialing, dating, and noting collection times.
Education
Bachelor of Science - Chemical Engineering
Drexel University
Philadelphia, PAPhiladelphia, PA
Skills
- Lean
- six sigma
- Microsoft Office Suite
- Oracle
- SAP (ERP)
- Power BI
- Sharepoint
- Minitab
- ETQ
- Trackwise
- OGSM
- CIP
- PMO Governance, Capex/Opex Management
- Competencies: Portfolio Prioritization, Resource Allocation, Stakeholder Management, Financial Acumen, Risk Management
Websites
References
Jodie L., Professional and personal acquaintance, I have been working with Shawn at Johnson & Johnson for the last 10 years and at Merck for 3 years. I know him professionally and personally. He has grown tremendously over the years and has become one of the most valuable, very dependable, knowledgeable, and responsible individuals that I would always seek out for advice. At work, he is responsible for managing our external manufacturing partner’s deviations and Change Controls that must comply with regulatory, quality and manufacturing regulations.
Early Career Highlights
- Medic, Medical Dept., United States Army Reserves, Fort Dix, NJ, Maintained medical records of 500 incoming soldiers. Trained 25 EMTs in life support skills. Administered tests and medication to stabilize patients. Conducted equipment and vehicle checks to maintain continuous and safe operation.
- Project Engineer, Measles, Mumps, Rubella (MMR), Pro-Staff, South Amboy, NJ, Directed cross-functional team in developing project schedules and monitored metrics to evaluate team performance and results. Collaborated with company executives and project managers to acquire required resources.
- Plastic Additives Engineer, Atofina Chemicals, King of Prussia, PA, Trained 10 technicians in four weeks, on the digital Torque Rheometer, heat distortion tester, and industrial press while ensuring strict compliance with safety standards and efficiency procedures.
- Lab Technician, Garlock Valves and Industrial Plastics, Camden, NJ, Maintained inventory and reordered before supplies diminished. Tracked and collected specimens by initialing, dating, and noting collection times.
Professional Development
- Training in Engineering, Business Management, Business Strategy
- ASQ Certified Auditor
- Six Sigma Green Belt (2023)
Timeline
Senior Process Specialist - External Manufacturing
Johnson and Johnson/Kenvue
09.2024 - Current
Site Lead, External Manufacturing
Johnson & Johnson
12.2022 - Current
Senior External Manufacturing Investigator
Johnson & Johnson
01.2013 - Current
Audit and Validation Specialist, Consent Decrees
Pharma Bio Serve
09.2012 - 01.2013
Senior Operations and Manufacturing Supervisor
Merck & CO. Inc.
01.2007 - 01.2012
Viral Vaccine Engineer
Pro-Staff
01.2004 - 01.2007
Lead Process Engineer, Pilot Plant
Philadelphia Water Department
01.2002 - 01.2004
Medic, Medical Dept.
United State Army Reserves
Project Engineer, Measles, Mumps, Rubella (MMR)
Pro-Staff
Plastic Additives Engineer
Atofina Chemicals
Lab Technician
Garlock Valves and Industrial Plastics
Bachelor of Science - Chemical Engineering
Drexel University