Senior Manager, Tech Transfer & Site Readiness

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team! 

• Provide functional leadership and accountability for the site Technology Transfer process.
• Lead cross-functional Technology Transfer teams including R&D, Analytical, Packaging Development, Formulation Development, Quality, Manufacturing, Warehouse, Supply Planning, and other functions as required.
• Ensure effective Technology Transfer strategies, plans, risk assessments, execution activities, and manufacturing handoffs are established and completed.
• Drive transfer of products and processes from development into Manufacturing Operations while meeting safety, quality, regulatory, commercialization, and business requirements.
• Provide oversight, direction, and development to Technology Transfer personnel and drive resolution of technical or cross-functional issues affecting transfer timelines and manufacturing readiness.

• Lead Process Engineering activities supporting existing operations, new products, new equipment, and site-expansion initiatives.
• Provide leadership, technical direction, coaching, and development to the Process Engineer and other assigned technical resources.
• Ensure process requirements are translated into appropriate equipment, facility, utility, automation, and operating requirements.
• Support process design, scale-up, equipment selection, technical evaluation, troubleshooting, optimization, and continuous improvement.

• Serve as the internal Engineering Readiness lead for assigned capital, commercialization, capacity-expansion, and site-development initiatives.
• Translate product and process requirements into engineering design requirements and coordinate technical interfaces among Engineering, Manufacturing, Quality, Maintenance, R&D, external engineering/design partners, contractors, and equipment suppliers.
• Lead or participate in design reviews to ensure manufacturing, process, operability, maintainability, quality, safety, and technical requirements are incorporated into project designs.
• Support equipment specifications, technical requirements, layouts, process flows, utilities, and vendor technical evaluations.
• Identify engineering-readiness gaps, technical risks, decisions, and dependencies and drive them to appropriate resolution.

• Lead or coordinate Engineering readiness activities supporting equipment installation, commissioning, qualification, startup, and transition to operations for assigned scope.
• Partner with Quality, Manufacturing, Maintenance, Validation, and other functional teams to ensure technical readiness requirements are clearly established.
• Ensure engineering punch-list items, startup risks, technical deficiencies, and handoff requirements are identified, prioritized, and resolved.
• Support technical training, maintenance requirements, spare-parts strategies, operating documentation, and other Engineering deliverables required for sustainable operation.
• Ensure effective technical handoff of new processes, equipment, and manufacturing capabilities into stable operations.

• Provide internal technical leadership for assigned capital-project scope and establish Engineering milestones, dependencies, risks, and resource requirements.
• Support development of project scope, technical alternatives, engineering estimates, schedules, business cases, and capital requests.
• Provide Engineering input into project risks, change controls, priorities, and execution decisions.
• Support management of engineering consultants, equipment suppliers, contractors, and other external technical partners within assigned areas.
• Develop increasing capability in capital planning, forecasting, project controls, vendor management, and capital governance as responsibilities expand.

• Successful and timely transfer of new products and processes into Manufacturing Operations.
• Effective leadership and development of Technology Transfer and Process Engineering resources.
• Engineering deliverables and technical decisions completed in alignment with project and commercialization requirements.
• Successful engineering readiness for equipment installation, commissioning, qualification, startup, and operational handoff.
• Proactive identification and resolution of technical risks and execution barriers.
• Effective cross-functional alignment with Engineering, Manufacturing, Quality, R&D, Maintenance, Supply Chain, and program-management resources.
• Increasing independent ownership of Engineering execution with reduced need for day-to-day escalation to senior Engineering leadership.
• Development of repeatable Technology Transfer and Engineering Readiness capabilities applicable to future site projects.

• Required: Bachelor's Degree in Engineering, Science, or related technical discipline.
• Preferred: Master's Degree or advanced technical/business degree; relevant project-management or engineering certification.

• Strong knowledge of Technology Transfer, process engineering, manufacturing processes, and commercialization in a regulated manufacturing environment.
• Understanding of R&D-to-Manufacturing transfer and manufacturing-readiness requirements.
• Working knowledge of engineering project execution, equipment installation, commissioning, qualification, startup, and operational handoff.
• Familiarity with FDA, GMP, applicable ISO requirements, Good Engineering Practices, design controls, project planning, risk management, scheduling, change management, vendor management, and cross-functional execution.
• Familiarity with capital-project planning, budgeting, project controls, and capital governance, with the ability to develop deeper expertise as responsibilities expand.

• 7-10+ years of progressive experience in Technology Transfer, Process Engineering, Manufacturing Engineering, Project Engineering, Manufacturing Operations, or related technical disciplines.
• Experience in a regulated manufacturing environment.
• Demonstrated experience leading cross-functional technical projects from development or concept through implementation and transferring products, processes, or technologies into manufacturing.
• Experience leading technical personnel and/or cross-functional teams.
• Experience supporting new equipment, manufacturing expansion, capital projects, commissioning, startup, or site-readiness activities preferred.

• Strong technical problem-solving and analytical capability.
• Demonstrated ability to communicate clearly and effectively, both verbally and in writing.
• Ability to lead cross-functional teams, influence without direct authority, and make sound decisions through ambiguity and competing priorities.
• Ability to identify risks and escalate significant issues with clear recommendations and alternatives.
• Ability to effectively delegate, coach, and develop team members.
• Working understanding of business and financial concepts.
• Detail-oriented, self-directed, collaborative, and results focused.

• No hazardous or significantly unpleasant conditions.

• $160,000 - $170,000 annually, plus bonus