Mukesh J. Yadav
Simi Valley,USA
Summary
Pharmaceutical engineering and maintenance leadership Total 22 plus years' experience working at Takeda, Genentech, Amgen, Lonza, MassBio, Jacobs and PM group with Biopharmaceutical manufacturing and Engineering companies. Chemical Engineering and MBA degrees 10 years as experienced technical and people manage, hiring, coaching, mentoring, building and leading teams. Strategic directions and Leadership Fill and Finish operations; Single Use technology; Cell Culture and drug product manufacturing; GENE therapy Automation scope integration, Reliability practices, Maintenance and MRO integration experience Owned Project management, CAPEX and OPEX projects life cycles Business Case development, Project initiation, Conceptual design, basic Design, Details design, Construction, and commissioning of projects. Worked with engineering firms i.e. Jacobs group, PM Group Lab (QC/ R&D), Clinical and commercial manufacturing facilities support EH&S support /Chemical Handling P & Ids, TOPs, and engineering drawings Monitoring KPIs and IFM FDA, EMA, and other agency inspections GMP Documentation; QA Change Controls / CAPA/ Track Wise Security / Janitorial/Site services, Landscaping / Pest Control
Overview
38
38
years of professional experience
Work History
Head of Plant engineering and utilities
Takeda Pharmaceuticals
09.2022 - 09.2024
- Proven Engineering leader with the ability to establish a vision for an organization and accomplish towards that vision while using solid engineering methodology
- Provide management to a team of managers, superintendents and supervisors while maintaining responsibility for implementing all activities within the facilities team
- The primary focus of this role is to ensure plant specific engineering goals (safety, compliance, fulfillment, and financial) are achieved through the efficient use of resources
- Vision to identify excellence in engineering, facilities, and maintenance and build a motivated team to achieve it
- Managing a team of Engineers, Utilities, HVAC, and Facilities with 22 colleagues (6 direct reports)
- Supporting day to day manufacturing filling and packaging operations on 24 x7 basis
- Skills: Product Management
- Business Process Improvement
- Troubleshooting
- Presentation Skills
- Project Management
- Engineering Management
Senior Manager -TL- Utilities ( GMP and Non-GMP) and Facilities
Pfizer Inc.
06.2021 - 09.2022
- Facilities Business Unit to ensure efficient, economical, continuous, and safe utilization of existing and future plant facilities while in compliance with all cGMP’s
- Provides GMP / Non GMP utility service to all users (WFI, Pure steam, Plant steam, Cooling water, HVAC, Electricity, GMP gases and Compressed air)
- Maintains and improves the facility, GMP and Non-GMP utilities
- Manage utilities and facilities engineers, operation, and maintenance staff
- Management of IFM and MRO service providers
- Managing a team of Utilities, HVAC, and Facilities with 47 colleagues (9 direct reports)
- Supporting day to day manufacturing filling and packaging operations on 24 x7 basis
Associate Director- Engineering, Facilities and EHS
True Binding
03.2021 - 05.2021
- Company Overview: Truebinding is a startup biotherapeutics development company focused on creating new and exciting antibody for metabolic diseases and cancer, based on our proprietary Truebinding platform with great unmet medical needs
- Develops and implements facilities policies and practices and ensure all project and vendor/contractor work meets EH&S and Sustainability compliance and apply all applicable safety regulations; follow published and accepted safety practices and maintain a clean, safe working environment; ensure our facilities are always kept clean and neat
- Supported design / build efforts for the new manufacturing facilities
- Supported GMP R&D laboratories and Clinical manufacturing Lab activities including EH&S
- Provide predictive and preventative maintenance support to ensure maximum facility uptime, responsible for repairs and improvements made to TrueBinding facilities
- Created positive relationships with landlords, vendors and employees at all levels and balances business needs
- Responsible for the safety and security of employees at TrueBinding facilities
- Truebinding is a startup biotherapeutics development company focused on creating new and exciting antibody for metabolic diseases and cancer, based on our proprietary Truebinding platform with great unmet medical needs
Manager- Utilities (GMP and Non-GMP)and Maintenance Engineering
Lonza Biotech and Pharma
07.2020 - 03.2021
- Responsibility for delivery of reliable operation, maintenance and calibration of all plant utilities, manufacturing equipment, HVAC systems including, RO/ DI water, steam, WFI, CDA, process gases, Lab equipment, waste/ neutralization, process equipment, air handlers and temperature-controlled rooms and equipment
- Direct and lead daily work of Utilities/ Maintenance/ Calibration Departments including budgeting, hiring, and staffing and performance management
- Responsible for contractor vetting and supervision in areas of plant security, janitorial services, landscaping, and pest control programs
- Manage facilities related projects and ongoing upgrades for utilities equipment
- Provide support for facilities GMP audit by clients
- Direct management of engineers, maintenance technicians, calibration staff and securities and Janitorial staff
- EH&S support and Laboratory equipment support
Senior Project Manager and Senior Facilities Engineer
PM Group. JOINN Biologics, Boehringer Ingelheim
03.2018 - 06.2020
- Supervision and management of staff and contractors
- Provided technical and engineering leadership for restart of clinical drug manufacturing facilities (Ex-Bayer facilities)
- Provided engineering and technical leadership for selection of right single use technology
- Worked with Biopharmaceutical clients as per below as consultant in Bay area as Project Manager and Facilities /Utilities Engineer / Start up engineer/ Process engineer
- Worked on design of BioMarin lab/clinical expansion/ retrofit project
- Led utilities design, selection of equipment, layout, P & Ids, basic and detailed design for utilities systems including WFI, process gases, CDA and critical utilities
- Led startup efforts for JOINN Biologics for utilities equipment including CDA, WFI, RO, DI, Boilers, Pure steam, and process gases
- Prepared budget, schedule, and resource needs for startup of decommissioned plant
- Supervised engineers, equipment vendor and service provided
- Coordination with local and state authorities for licensing of equipment
- Provided validation support for utilities equipment
- Provided directions to site security operations
Senior Project Manager and Senior Facilities Process Engineer (GMP utilities)
Genentech Inc
07.2009 - 10.2017
- As project manager, completed several projects for utilities, facilities, and process equipment from scope development to completion i.e., project initiation, options analysis, basic design, detailed design, procurement, start up, commissioning, validation, and handover
- As PM, handled small, medium, and large size Project projects
- Owned and executed facilities reliability, compliance, and audit related projects
- Supervised and managed team of 20 team members including SMEs, engineers, interns, A/E firms, general contractors, and service providers
- Managed project budget, forecast and managed internal and external resources, interacted with engineering companies and technical SMEs
- Developed project budget, interacted with finance for financial calculations and monitor business case validity
- Lead Technology representative in Quality Council team - Utilities and Facilities Council (UFC)
- Led Engineering Design Review (EDR) for Utilities and facilities
Facilities/Process Utilities engineer (GMP and Non-GMP)
Massachusetts Biologic Laboratories, MBL
05.2006 - 07.2009
- Company Overview: MBL has clinical manufacturing, labs and R & D facility building
- Supervised team of operation and maintenance staff and project management contractors
- As lead process engineer for Facilities and GMP Process Utilities, worked on projects for DI systems, WFI/ RO system, clean steam systems and visual inspection machine
- As responsible system owner ensured that state of utility systems (RO/DI system, WFI system, USP water system, Lab water system and Clean Steam system) is sound, reliable for process use, validated, and compliant
- Participated in CAPEX and OPEX projects
- MBL has clinical manufacturing, labs and R & D facility building
Process Utilities (GMP) Engineer / Project management
Amgen Inc
02.2003 - 04.2006
- Company Overview: Amgen, Rhode Island is commercial manufacturing and Lab building facility
- EH&S support and Laboratory equipment support
- As Responsible System Owner (RSO) and Lead GMP process utilities engineer on 24 x 7 basis, ensured that state of utility systems (RO/ DI system, WFI system, Purified water system, Lab water system and Clean Steam system) is reliable for process use, and compliant
- Supported QC lab building of 60,000 square feet
- Worked with QC lab owners to support plant utility needs
- Supported manufacturing plant of approx
- 125,000 square feet
- Day to day coordination involved working with Quality, Projects, Regulatory, Manufacturing, Validation, Operations, Maintenance Work Order administration and QACC for Change Records
- Performed successful investigations on WFI, USP and Clean steam systems
- SOPs and GMP documentations support
- Participated in CAPEX and OPEX projects
- Amgen, Rhode Island is commercial manufacturing and Lab building facility
Process engineer
Jacobs Engineering
10.1999 - 01.2003
- As a Utilities SME/ Process engineering provided support for design of process/utilities equipment and systems, preparation of P & I diagram, equipment layouts, system specification and data sheet
- Developed and maintained engineering specifications and standards
- Provided engineering support for Biopharmaceutical clients including Merck, Schering Plough, Wyeth-Ayerst, and Glaxo SmithKline
Senior Applications Engineer
Cochrane, Inc.
06.1996 - 08.1999
Project Manager/ Senior engineer
Aquatech International Corporation.
03.1992 - 06.1996
- (Engineered RO/DI Water systems)
Project engineer / Manager/ Start up Engineer
Ion Exchange India Ltd.
10.1986 - 02.1992
- (RO/DI water systems)
Education
Master of Business Administration (MBA) - Business Management
West Chester University
West Chester, PABachelor of Science - Chemical Engineering
UDCT
Skills
- Product Management
- Business Process Improvement
- Troubleshooting
- Presentation Skills
- Project Management
- Engineering Management
Certificationscourses
- License to Manage, Lonza, 2020
- NextGen Leadership Forum, Genentech, 2017, 5 months
- Leadership Accelerator Course, University of California, Berkley, CA, 2017
- ISPE Facilities Project Management Course, 2015
- High Purity Water Treatment Courses and Conferences, 2016
- HVAC for Pharmaceutical Facilities – ISPE meeting, 2014
- Design, Engineering and Validation of Biopharmaceutical Process Systems Course, 2013
Affiliations
- International Society for Pharmaceutical Engineer (ISPE), 2001
- Participated in Community of engineering good practice guides for the industry.
- Requested by ISPE to review ISPE “Water and Steam guide / process gases / Utilities “guides before they get published.
Presentations
- Genentech Global process engineering conference, 2010, Commissioning of PSG-5
- Ultrapure Water (UPW) conferences, 2011, Case Studies in selection of right process paths and practices for Pharmaceutical Water Systems, New Jersey
- Ultrapure Water (UPW) conferences, 2013, Engineering solutions for Bioburden control in Pharmaceutical Water systems, Chicago
- Biopharmaceutical Waters Seminar, Chair
Timeline
Head of Plant engineering and utilities
Takeda Pharmaceuticals
09.2022 - 09.2024
Senior Manager -TL- Utilities ( GMP and Non-GMP) and Facilities
Pfizer Inc.
06.2021 - 09.2022
Associate Director- Engineering, Facilities and EHS
True Binding
03.2021 - 05.2021
Manager- Utilities (GMP and Non-GMP)and Maintenance Engineering
Lonza Biotech and Pharma
07.2020 - 03.2021
Senior Project Manager and Senior Facilities Engineer
PM Group. JOINN Biologics, Boehringer Ingelheim
03.2018 - 06.2020
Senior Project Manager and Senior Facilities Process Engineer (GMP utilities)
Genentech Inc
07.2009 - 10.2017
Facilities/Process Utilities engineer (GMP and Non-GMP)
Massachusetts Biologic Laboratories, MBL
05.2006 - 07.2009
Process Utilities (GMP) Engineer / Project management
Amgen Inc
02.2003 - 04.2006
Process engineer
Jacobs Engineering
10.1999 - 01.2003
Senior Applications Engineer
Cochrane, Inc.
06.1996 - 08.1999
Project Manager/ Senior engineer
Aquatech International Corporation.
03.1992 - 06.1996
Project engineer / Manager/ Start up Engineer
Ion Exchange India Ltd.
10.1986 - 02.1992
Bachelor of Science - Chemical Engineering
UDCT
Master of Business Administration (MBA) - Business Management
West Chester University
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