Associate Project Manager - Product Transfer

What you will do:

• Development of the project charter and management plan.
• Direct, manage, monitor, and control project. Evaluate tradeoffs within project.
• Collaborate with project stakeholders to develop, manage and own project scope.
• Develop and manage the detailed project Gantt chart. Analyze critical path, major workstreams, and intersecting milestones.
• Collaborate with cross-functional managers to define project budget. Monitor and maintain costs within budget.
• Develop a risk management plan for the project. Identify, analyze, and understand project risks; develop and monitor a risk response plan.
• Develop a Procurement Management Plan and collaborate on the selection of procurement partners.
• Participate in the development of the validation and verification plan of the manufacturing processes at the vendor sites
• Participate in PFMEA, Control Plan, SOP and PPAP generation associated with product transfers.
• Incorporate end-user feedback to refine scope through the project lifecycle and can communicate changes, updates and decision to key stakeholders.

What you will need:

Required Qualifications:

• Bachelor's degree related to Engineering or other related field of study
• 4-7 yrs of relevant Experience.
• Proven Project Management skills through the delivery of business-critical projects.
• Strong communication and influencing skills with both internal and external stakeholders.
• Experience with design remediation and engineering development, including IQ/OQ/PQ and design verification & validation

Preferred Qualifications:

• PMP or equivalent preferred
• Capable of providing technical leadership and, influencing and providing technical direction to Engineers, Technicians and Operators as required.
• Demonstrable strong analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced environment
• Experience in an FDA regulated or regulated industry beneficial.