Henry Baez

Experience

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  Wyeth Biotech

  Jun 2006 - Jan 2007

  Intern

  As an intern my responsibilities included:• Conduct field reviews of process equipment • Lead decommissioning of master and working seed storage, low temperature equipment during plant shutdown• Define User Requirement Specifications and serve as the end user representative on major process capital projects• Procure instrumentation through site capital engineering SOPs and prepared Change Control documentation• Gathered, reviewed and corrected documentation and drawings to create process binders• Assisted in engineering projects i.e. pH testing, optical instrumentation installation and process walkthroughs Show less

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  Pfizer Biotech

  Jun 2007 - Aug 2010

  As a compliance Investigator, it was my job to investigate and write reports on major and minor batch manufacturing deviations to $3 Billion Prevnar(R) Vaccine including:performing root cause (PEMMES and Fishbone Diagram), regulatory license, validation and impact analyses, determining and initiating short and long-term corrective actions and providing recommendations for multi-million dollar batch disposition. In my current position I also lead Departmental Continuous Improvement/Kaizen initiatives. This leadership position includes performing cost savings/impact analyses for departmental projects, and providing Project Plans and Implementation Timelines. Show less Under this position it was my responsibility to provide engineering support in manufacturing $3 billion Prevnar Vaccine. This responsibilities included:• Managing multiple capital projects simultaneously within a budget and planned execution schedules• Developing User Requirement Specifications, and served as Process Engineering/End User Representative on major process capital projects procurement, installation and qualification (IQ, OQ, PQ, CV, PV) for Fermentation, Clarification and Purification processes• Leading Cross Site Process Analytical Technology (PAT) initiatives• Developing and Author Standard Operating Procedures (SOP) and Regulated Documents for the Production Area• Redlining and annotate P&IDs and Process flow diagrams• Performing Risk Analysis Evaluations on process equipment, instrumentation and procedures• Assisting in resolving FDA and Regulatory observations• Developing and implement low pH process to enhance production batch yield for • Assisting in resolving Manufacturing Investigations and Ensuring Commitment closures• Performing equipment and facility evaluations to optimize performance and ensure enhanced schedule adherence• Resolving emergency and safety issues in the process area• Participating in and running Operational Excellence teams i.e. Kaizen, Risk assessments, Continuous Improvements Show less

  • Compliance Investigator

    Jan 2010 - Aug 2010

  • Process Engineer I/II

    Jun 2007 - Dec 2009
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  Zimmer TMT

  Aug 2010 - May 2014

  Manager of Quality Systems operations including CAPA, manufacturing investigations, design control, supplier control, Validations and all other QSR elements. - Maintain and improve manufacturing processes - Design and execute equipment/process validations- Perform manufacturing investigations to resolve product and product/manufacturing issues-Lead corrective and preventative action (CAPA) projects to resolve - Assisting in the design, FAT, SAT, commissioning, process development and validation (IQOQPQ and product validations)of new production reactors as well as new Design and review Equipment, Process and Software Validations, Manage the site Validation Master Plan, Assist in Manufacturing Investigations. Process Improvement and Process Remediation Planning.

  • Quality Engineering Manager

    Feb 2013 - May 2014

  • Senior Process Engineer II

    Aug 2012 - Feb 2013

  • Senior Quality Engineer

    Aug 2010 - Aug 2012
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  Siemens

  Jun 2014 - Jul 2016

  Responsible for planning and managing internal Audits of all Siemens healthcare global medical device manufacturing sites.

  • Senior Compliance Audit Manager

    Jan 2016 - Jul 2016

  • Manager, Compliance Audit

    Jun 2014 - Dec 2015
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  Siemens Healthineers

  Jul 2016 - now

  Global multi-site Responsibilities for Instrument Manufacturing quality. Multi-site quality management representative with oversight of Quality Assurance personnel and activities at the Flanders, NJ and Brookfield, CT manufacturing locations.

  • Vice President, Head of Lab Solutions Manufacturing Quality

    Jul 2023 - now

  • Head of Laboratory Diagnostics Global Quality Management

    Jul 2021 - Jul 2023

  • Head of Global Instrument Manufacturing Quality

    Nov 2019 - Jul 2021

  • Senior Director of Quality Assurance, Instrument Manufacturing - USA

    Jul 2016 - Nov 2019