Michael Ii
Principal Validation Engineer at Performance Validation | Fowlerville, Michigan, United States
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As a Principal Validation Engineer at Performance Validation, Michael II brings a wealth of expertise in pharmaceutical validation, underpinned by extensive experience in Good Manufacturing Practice (GMP) compliance and quality assurance. In his current role, he leads critical validation efforts for capital projects, ensuring that all systems and processes meet stringent regulatory requirements. His proficiency in Process Validation and Computer System Validation is complemented by his hands-on experience with laboratory equipment qualification and 21 CFR Part 11 assessments, which are essential for maintaining compliance in today’s highly regulated environments.
Michael is currently spearheading several key projects, including the development and oversight of sterilization processes using steam and vaporized hydrogen peroxide (VHP). His involvement in cleaning validation support and serialization equipment upgrades highlights his commitment to enhancing operational efficiency and product safety. Additionally, he plays a pivotal role in the creation and approval of Automation System Lifecycle Documentation, ensuring that all automated systems are validated and compliant throughout their operational life.
His strong project management skills enable him to effectively coordinate cross-functional teams while conducting quality risk assessments and nonconformance evaluations. Michael’s expertise in building management system monitoring commissioning and qualification validation further underscores his capacity to manage complex validation projects from inception to completion. With a focus on continuous improvement and adherence to industry standards, Michael II is dedicated to advancing the field of pharmaceutical validation, making significant contributions to both his organization and the broader biotechnology landscape.
Principal Validation Engineer at Performance Validation in December 2021 to Present
Senior Validation Engineer at Performance Validation in August 2020 to December 2021
Validation Project Lead at Grand River Aseptic Manufacturing in January 2017 to May 2019
Sr. Validation Engineer at Grand River Aseptic Manufacturing in October 2015 to January 2017
Validation Engineer at Emergent BioSolutions in June 2012 to October 2015
Quality Assurance Specialist at Emergent BioSolutions in May 2010 to June 2012
Chemical Technician at Henkel in April 2006 to October 2009
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Problem Solving
Project Management
Project Commissioning
Software Testing
Presentations
Quality Assurance
Validation
GMP
21 CFR Part 11
GxP
Equipment Qualification
Deviations
Change Control
V&V
Aseptic Processing
CAPA
SOP
Pharmaceutical Industry
Biopharmaceuticals
LIMS
FDA
Biotechnology
Process Validation
Cleaning Validation
Vaccines
Aseptic Technique
Computer System Validation
Quality System
Standard Operating Procedure (SOP)
U.S. Food and Drug Administration (FDA)
Good Manufacturing Practice (GMP)
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Discover more about Performance ValidationWhat is Michael Ii email address?
Email Michael Ii at [email protected] and [email protected]. This email is the most updated Michael Ii email found in 2026.
What is Michael Ii phone number?
Michael Ii phone number is +15174833138 and +15178616589.
How to contact Michael Ii?
To contact Michael Ii send an email to [email protected] or [email protected]. If you want to call Michael Ii try calling on +15174833138 and +15178616589. (updated on October 30, 2024)
What is Michael Ii net worth?
Michael Ii has an estimated net worth of $2,500 to $24,999
What company does Michael Ii work for?
Michael Ii works for Performance Validation
What is Michael Ii's role at Performance Validation?
Michael Ii is Principal Validation Engineer
What industry does Michael Ii work in?
Michael Ii works in the Pharmaceutical Manufacturing industry.
Michael Ii Email Addresses
Michael Ii Phone Numbers
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