Biopharmaceutical Engineering/ CQV professional with over 20 years of experience. Strong Project Manager with ability to manage multiple projects and teams. Leverages design and start-up experience with new Biopharmaceutical manufacturing facilities and process systems. Leverages Engineering, Manufacturing, Commissioning, Validation, and Utility experience in support of Biopharmaceutical manufacturing.
 

• Manage the execution of the capital engineering strategy to support the Engineering, Procurement, Construction, & Management (EPCM) of Biopharmaceutical Manufacturing Facilities.

• Lead/ coordinate key technical project deliverables involving Feasibility, Conceptual Design, Basic Design, Detailed Design, Construction Oversight, and Operational Readiness.

• Support the development, execution, and updating of the Integrated Project Schedule (IPS): from Conceptual Design, Detail Design, Construction, Operational Readiness, Commissioning, Validation, and Full Release for manufacturing.

• Provide design, CQV, and operational oversight of the Manufacturing Facilities and support areas.

• Support the development of the MFG Facility Design, Equipment URS, Specification/ Quotation, Purchase, Delivery, Installation, and Commissioning.

• Support the Capital Project Strategy, Design, Specification, RFP Procurement, and Project Management.

• Manage the project budget and provide performance dashboards.

• Lead the cross functional team in the development of the Manufacturing Readiness requirements and implement into the IPS.

• Manage the project contracts, budgets, and develop timelines.

• Leverage engineering standards in supporting Detail Design of Manufacturing Facility.

• Lead in the execution process and risk assessment throughout the project.

• Support the development of the Commissioning and Validation Master Plans for the project.

• Identify project gaps and escalate remediation plans to the steering team for approval.

• Support the development of the Commissioning and Validation Master Plans for the project.

• Responsible for the management of the development, design, planning, execution, review and final sign-off of CQV protocols.

• Establish and maintain the projects Master Equipment/ System List.

• Utilizes the company library in the development of the Basis of Design, Request for Proposal, User Requirement Specifications, Design Specifications, Integrated Project Schedule, performance Dashboards, A3’s, Bid Assessments, and Risk Assessments.

• Support the implementation of the Tech Transfer Process of products into MFG Facilities.

• Apply Quality by Design principles, experience which aligns with FDA, ICH, and ISPE guidelines.