Principal Engineer, Global Technical Operations, Engineering & Innovation

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Principal Engineer (Global Technical Operations, Engineering & Innovation), acting as a subject matter expert, provides oversight in the design of state of the art isolated sterile fill finish and lyophilization equipment and supporting plant systems through direct involvement and/or managing a cross functional team, supports fine tuning and continuous improvement objectives in assuring equipment or systems operate at optimal performance.

The Global Principal Engineer is responsible for providing technical leadership and management in the delivery of Front End Engineering Designs which includes cross functional collaboration to develop Project Charters, Project Scope Definitions, Project Business Requirements (business case), and economic evaluations needed to support project approvals, stage gate reviews, project governance, etc. This position requires ability to interact and galvanize input through all levels of the organization including Senior Leadership and C Suite.

Responsible for driving segment level standardization of engineering and facilities approaches, tools, ways of working, Lean Manufacturing, and Continuous Improvement. Supports master planning, manufacturing asset assessments, and 5 year Cap Ex planning across the segment in alignment with enterprise priorities. Provides engineering mentoring to Site engineering teams in collaboration with engineering management.

• Be Subject Matter Expert (SME) in isolated or RABS sterile fill finishing and lyophilization equipment and operations.
• Manages Front End Engineering Design efforts to develop project scopes, cost estimates, and schedules in accordance with identified project priorities and business objectives providing deliverables for the foundation of business case evaluations in a CDMO environment.
• Manages external engineering partners and internal cross functional teams in the execution and delivery of Front End Engineering Designs
• Develop and implement segment level engineering standards, establishing clear baseline requirements and governance to drive consistency across engineering and facilities teams.
• Drive standard work creation and process documentation discipline.
• Investigate, develop, and recommend alternatives for design, procurement, and installation of new/modified equipment or systems for the optimal utilization and control of resources.
• Institute project teams and governance structures.
• Lead and execute site Manufacturing Asset Assessments across the segment.
• Lead and execute Site Master Planning across the segment.
• Conduct troubleshooting and/or technical analyses on operational equipment and processes.
• Establish Project Charters including scope of work, goals, and deliverables in collaboration with project champion/sponsor to support business objectives in alignment with senior leadership and key stakeholders.
• Organize project governance requirements and subsequently coordinating communications and meetings in compliance with the governance.
• Liaise with project stakeholders on an ongoing basis.
• Ensures inclusion of Global Quality Tech Operations personnel in key decisions and project delivery efforts.
• Ensures inclusion of Site Operations (Manufacturing, Engineering, Quality, Validation, etc) personnel in site related projects and continuous improvement efforts.
• Drive a culture of Lean Manufacturing and Continuous Improvement at all levels within the organization through the use the site maturity index.
• Developing metrics to manage, evaluate, and communicate progress on assigned tasks, projects, improvement efforts, etc.
• Leads the implementation of major capital projects as needed. Provide technical support through the gate process, during pre-construction phase, and coordinate daily activities with the production area and project management and contractors. Prepare URS, Risk Assessments, Safety Assessments associated with the project.
• Leads the effort with end users to develop system requirements, specification of equipment/buildings, review design from outside engineering firms or contractors (as needed), overseeing fabrication…