Bill Ogden Email and Phone Number
Bill Ogden work email
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Bill Ogden personal email
I am an expert in the design, construction, operation, maintenance, and validation of GMP Biotech process equipment, facilities, and utilities; with over 35-years of cGMP Engineering Experience: supporting Biotech, Vaccines & Sterile GMP manufacturing; including 21-years of Commercial Manufacturing and 15-years of Clinical Manufacturing experience.SKILLS:• Problem Solving – Demonstrated ability to identify root causes and implement innovative solutions• Getting Things Done – Taking initiative and following through to successfully accomplish goals• Transformation – Fixing things that are broken, and Making good things great• Design Engineering – Process, Equipment & Facility design• Contamination Control – Expert in contamination investigations and preventing contaminations• Strategic Thinking / Process & Equipment Optimization• Leadership – Strong Leadership and Project Management skillsTECHNICAL EXPERTISE: • Biotech, Vaccine, and Bulk Sterile manufacturing and engineering• Bioprocess equipment design, operation, maintenance, validation, and optimization.• Pharmaceutical Facility and Cleanroom design, operation, and environmental control • Biopharmaceutical, Sterile and Aseptic processing, including CIP, SIP, and contamination control• Clean Utilities including: WFI, High Purity Water Systems, Clean Steam Author of the "Revealed Truth" blog, located at: https://www.RevealedTruth.com
Ogden Engineering Solutions
View- Website:
- ogdenengineeringsolutions.com
- Employees:
- 1
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Owner And Principle EngineerOgden Engineering SolutionsWashington, Dc, Us
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Director Of EngineeringAstrazeneca Nov 2023 - PresentCambridge, Cambridgeshire, GbA lead design and project engineer for new capability and large capital improvement projects supporting GMP Clinical Manufacturing.- Lead design and project engineer for a $2MM Hot and Cold WFI upgrade project- Lead manufacturing project engineer for design and construction of a new $50MM, 80K sq ft GMP warehouse.- Supporting manufacturing capacity improvement projects and implementation of Next-Gen-Manufacturing (NGM) capability in AZ clinical manufacturing located in Gaithersburg, MD- Provide engineering guidance, mentoring, coaching and training -
Director Of Engineering ServicesAstrazeneca Sep 2008 - Oct 2023Cambridge, Cambridgeshire, GbI managed a group of engineers who support GMP clinical manufacturing. They are the go-to process equipment experts who keep Manufacturing producing.Accomplishments included:• Lead manufacturing engineer in the design and building of AstraZeneca's first GMP Cell Therapy manufacturing facility.• Lead manufacturing engineer for a $17MM project to retrofit an existing manufacturing space to a High Containment Suite to perform GMP clinical ADC conjugation.• Lead manufacturing engineer for a preliminary design and cost estimate to add a clinical scale GMP sterile filling suite in OMW (capable of ADCs as well as standard biologicals)• Resolved Bioreactor exhaust filter clogging issues• Led the design, installation and start-up of AZ's first HTST unit for viral inactivation of media used in GMP bio-manufacturing.
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Senior EngineerAmgen Nov 2003 - Sep 2008Thousand Oaks, Ca, UsContamination Control Specialist • Led cross-functional contamination investigation efforts to reduce the risk of microbial contaminations• Developed and implemented optimization strategies in Cell Culture Manufacturing related to equipment sterilization and aseptic processing. • These efforts resulted in being contamination free for 2 years, and the elimination of roller bottle contaminations by P. acnes and other organisms• Participated in the investigation of and recovery from a viral contamination with MMV -
Sr EngineerMerck Jun 1997 - Nov 2003Technical Operations - Project/Process Engineer: Provided technical support to the Bulk Sterile Antibiotic Area including leading annual bulk sterile challenges, conducting Sterility Assurance and Infrastructure projects, providing technical and scheduling leadership for annual shut downs, and participating in capital upgrade projects. • Led the initial validation of Media Challenge procedures for the sterile processes in Factory 7• Led a project to develop a custom, sanitary, sterilizable double mechanical seal to retrofit into a sterile filter dryer to improve sterility assurance and equipment reliability. • Performed a sterile manufacturing gap analysis of Factory–7 to evaluate sterility assurance and regulatory compliance. This sterile manufacturing compliance report became the basis for evaluating all sterile manufacturing at Merck.• Revised the CIP and SIP procedures for 14 process vessels.• Supported various capital projects in the Bulk Sterile Antibiotic Area. Responsibilities included scope, functional requirements, P&ID and specifications development, detailed equipment design, 3D facility and piping layout, and scheduling support.
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Senior Manufacturing EngineerMerck Mar 1990 - Jun 1997Biological Manufacturing Engineering Support:Lead design engineer representing the Biological Manufacturing Engineering Support (BMES), Manufacturing, and Maintenance departments in the design and construction of a new GMP Polysaccharide Vaccine Production Facility.• Helped develop and approve all equipment specifications, PFDs, P&IDs, FRS’s, and architectural and equipment layouts• Participated in 3D detailed skid design, FRS & DDS development, FAT, and IQ/OQ of the Fermentation and Recovery area equipment, the CIP skids, Media/Buffer Prep skids, and the Utility systemsSenior Mechanical Supervisor, March 1990 - June 1995: Supported all the microbial production equipment in Biological Operations• Executed capital projects to replace two decontamination autoclaves and two Sharples centrifuges. • Designed and installed custom mechanical seal for three fermentor agitators and a fermentor mechanical foam breaker. Flow Serve made this seal part of their product line, and it is still available. • Supported the design and installation of three new clean rooms. • Helped design and start up a new fermentation suite.
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Utilities SupervisorMerck Feb 1988 - Feb 1990Supervised two utility shops including 14 people. Learned about building and GMP utilities while supporting five Pharmaceutical Production and Sterile Operations buildings. Solved recurring problems with two overloaded HVAC fans, leaking Chilled Water isolation valves, inoperable air handler controls.
Bill Ogden Skills
Bill Ogden Education Details
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Yale UniversityMolecular Biophysics & Biochemistry -
Navy Nuclear Power School And Training UnitNuclear Power - Engineering
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Calvary Baptist SeminaryTheology / Bible
Frequently Asked Questions about Bill Ogden
What company does Bill Ogden work for?
Bill Ogden works for Ogden Engineering Solutions
What is Bill Ogden's role at the current company?
Bill Ogden's current role is Owner and Principle Engineer.
What is Bill Ogden's email address?
Bill Ogden's email address is wd****@****msn.com
What schools did Bill Ogden attend?
Bill Ogden attended Yale University, Navy Nuclear Power School And Training Unit, Calvary Baptist Seminary.
What skills is Bill Ogden known for?
Bill Ogden has skills like Gmp, Validation, Biotechnology, Change Control, Biopharmaceuticals, Aseptic Processing, Project Management, Pharmaceutical Industry, Engineering, Continuous Improvement, Leadership, Purification.
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