Michael E. Mcclellan Email and Phone Number
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Leveraging an accomplished 15+-year history as a leader in metrology, validation, and calibration within industry leaders in biotechnology, pharmaceutical, and medical device production, I am a versatile and process-driven engineer committed to upholding compliance and quality objectives.In addition to proven competencies in establishing standards, procedures, and protocols, I bring demonstrated skills in leading team training and supervision to ensure compliance and partnering with external vendors, outside auditors, and senior managers to promote excellence in instrumentation and reporting.Further, I am a resolute and analytical problem solver adept in pinpointing failure sources and devising solutions to remediate concerning calibration trends. I have successfully implemented solutions to foster continuous improvement in maintenance programs, enhance validation software, and improve user competencies.I look forward to the opportunity to add you to my network today.
Rocket Pharmaceuticals
View- Website:
- rocketpharma.com
- Employees:
- 267
-
Calibration ManagerRocket PharmaceuticalsLevittown, Pa, Us -
Sr Manager Facilites, Metrology And Manufacturing SupportRocket Pharmaceuticals Mar 2022 - PresentCranbury, New Jersey, Us -
Calibration ManagerRocket Pharmaceuticals Nov 2020 - Mar 2022Cranbury, New Jersey, Us -
Supervisor, Engineering Calibration/Validation | Quality EngineerFujirebio Us Jun 2014 - Nov 2020Minato-Ku, Tokyo, JpFor Fujirebio Diagnostics, I schedule and supervise a dedicated team of metrology technicians, oversee metrology and instrumentation activities as well as validation operations; direct sourcing, commissioning, calibration, and training for new equipment and systems; and administer records databases and facilitate key data analysis, reporting, and auditing. Highlights of my contributions include:• Fostering a continuous improvement mentality in calibration and maintenance programs to reflect the most current landscape of industry best practices. • Directing the process to transition to a paperless validation software (Kneat) to elevate validation program consistency and data quality. • Generating thousands of dollars in savings by spearheading the process to consolidate departmental service contracts.• Leading an effort to develop a regulatory compliant equipment maintenance program to optimize risk management.• Providing guidance in the design of an HVAC for a new cleanroom to maintain proper aseptic processing and meet required specifications for cleanroom environments and delivering additional assistance to HVAC balancers to ensure the final build was to specification. -
Supervisor, Metrology/ValidationWuxi Apptec, Inc. Jun 2006 - Jun 2014Shanghai, Shanghai, CnFor Wuxi Apptec, I supervised metrology and validation functions for both laboratory and manufacturing equipment and systems. Beyond engaging a team of metrology technicians in implementing daily activities to meet project requirements, I also monitored metrology and instrumentation to ensure compliance with policies, procedures, standards, and regulations; calibrated new equipment and set intervals; liaised with external vendors and suppliers to schedule outsourced calibrations and repairs; and maintained calibration databases and produced regular reports..Highlights of my contributions include:• Sustaining levels of productivity while navigating a facility transfer to a new building.• Ensuring the successful integration of new leading-edge equipment, leading the process from research and recommendations to approval, commissioning, and calibration.• Leveraging an analysis of calibration results and trends to inform failure analysis, determination of root cause, and corrective action planning. • Serving as a technical subject matter expert while advising management and users on equipment. -
Metrology TechnicianApptec May 2004 - Jun 2006Us -
Metrology TechnicianMedimmune Nov 1999 - May 2004Gaithersburg, Maryland, Us -
Metrology TechnicianIts / Gsk Feb 1997 - Nov 1999Brentford, Middlesex, GbField service technician, Stationed at GSK from Feb 98 to Nov 99.
Michael E. Mcclellan Skills
Michael E. Mcclellan Education Details
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University Of PhoenixManagement | Finance -
Williamson Trade SchoolPower Plant Technology
Frequently Asked Questions about Michael E. Mcclellan
What company does Michael E. Mcclellan work for?
Michael E. Mcclellan works for Rocket Pharmaceuticals
What is Michael E. Mcclellan's role at the current company?
Michael E. Mcclellan's current role is Calibration Manager.
What is Michael E. Mcclellan's email address?
Michael E. Mcclellan's email address is mc****@****fdi.com
What is Michael E. Mcclellan's direct phone number?
Michael E. Mcclellan's direct phone number is +121537*****
What schools did Michael E. Mcclellan attend?
Michael E. Mcclellan attended University Of Phoenix, Williamson Trade School.
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Michael E. Mcclellan has skills like Calibration, Metrology, Biotechnology, Pharmaceutical Industry, Gmp, Manufacturing, Glp, Instrumentation, Gxp, Electronics, Fda Gmp, Automation.
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Michael E. Mcclellan's colleagues are Uttsav Patel, Joseph Kubu, Thomas Jackson, Arun B., Karamveer Birthare, Laura A Vasquez Valdez I Life Sciences Leader, Andrew Suarez.
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