Work Flexibility: Hybrid

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 sitesParticipate 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 study4-7 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 preferredCapable 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 environmentExperience in an FDA regulated or regulated industry beneficial.

Travel Percentage: 10%