Project Manager-Validation Lead

Location: Louisville, KY, United States
Date Posted: 11-01-2018
Ultimate Solutions is a trusted provider of packaging industrial automation, serialization and compliance for the Life Science Industries in United States, Puerto Rico and Europe. Over a decade, the Ultimate team has delivered proven results in hundreds of projects and thousands of service hours to the global leaders of pharmaceutical, biotechnology, medical devices and logistics markets.
 
We are recruiting a Project Manager or Validation Lead for a temporary assignment to manage a project portfolio that includes; process design, packaging vision system integration projects, packaging equipment projects, supply chain activities, serialization management, another task may be assigned.  
 
Responsibilities
Leads major, multiple, interrelated projects. Establishes the workplan for the project(s), identifies resources, manages client expectations, leads the design effort, and ensures the delivery of expected results on time and on budget.
Manage projects schedules to ensure on time completion
Supports the generation of quality assurance plans, verification plans, validation plans, and standard operating procedures as well as conduct risks assessments and participate in Quality/Regulatory audits.
Provide validation project and technical direction to lead the validation team as needed.
Develops and executes qualification protocols and final summary reports and may participate in commissioning activities.
Recognizes and helps mitigate project risk.

 
Requirements
BS Engineering or Science
5 years+ experience as Project Manager or Validation Lead
Third Packaging Logistics experience is a plus
Experience with regulated industries (FDA, ISO) is a must
Experience developing and executing validation master plan activities
Serialization experience (Systech system preferable)
ERP: SAP/ATTP/Cloud Base system advance knowledge
 
Ultimate Solutions is an equal opportunity employer.

 
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