Senior Manager, Tech Transfer & Site Readiness

Job Category
:
Managers

Requisition Number
: SENIO
006736

• Full-Time
• On-site

Showing 1 location

• Pay or shift range: $160,000 USD to $170,000 USD
  The salary range provided reflects the anticipated compensation for this position. Actual compensation will be determined based on several factors, including the candidate’s skills, qualifications, relevant experience, and overall expertise.

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!

The Sr. Manager, Technology Transfer & Site Readiness provides leadership for Technology Transfer, Process Engineering, and the engineering readiness activities required to successfully introduce new products, processes, equipment, and manufacturing capabilities into site operations. The role leads the transition of products and processes from tech transfer through manufacturing implementation while ensuring process, equipment, facility, utility, commissioning, startup, and technical handoff requirements are effectively integrated into capital and site-expansion programs.

• 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,…