This position is required to ensure execution and completion of assigned projects within cost, quality, and time requirements, and effective cost management for all process equipment / system improvement projects.
Assist in development and oversight of process equipment / system investment budget to include funding recommendations to capital committee.
Successful execution of site investment projects to support strategic goals of site.
Review and approval recommendations for all process equipment / system investment applications.
Responsible for identification of process equipment / system improvement projects to support CMC operational requirements.
Works closely with Manufacturing staff in the identification of improvement projects.
Responsible for ensuring project plan accomplishes time, quality, and cost objectives.
Assist with any training required of personnel supporting the project.
Assist with any training required of end users for process equipment / system improvement projects.
Responsible for execution of projects identified as supporting strategic goals for site.
Identifies and develops working relationships with affected customers at all levels; ensures that customer representatives are kept appropriately informed of project activities and are encouraged to participate as appropriate
Development and implementation of project plans
Completion of projects in accordance with cost, schedule, and quality metrics
Safe working environment
Other duties as assigned
Bachelors degree in Chemical or Electrical Engineering and/or equivalent experience.
8+ years project management experience in Manufacturing, Maintenance, or Process with a preference toward pharmaceutical or other regulated industries.
Knowledgeable in the following systems: biotech processing equipment (including bioreactors, chromatography, TFF, and CIP), HVAC and mechanical systems, electrical design, plumbing and piping systems, clean utilities (including WFI, clean steam, clean air, and lab gasses). Knowledge of clean construction, facility design, cGMP facility regulations.
Proven expertise in the following: mentoring/development, change management, planning/organizing, managing execution, and revising the work plan for complex problems solved by cross functional teams. Proven project management experience in management of multiple projects simultaneously.
Ability to work hours necessary to support production and /or maintenance activities.
Ability to lift up to 40 lbs. with assistance.
Ability to work in confined spaces and near operating equipment.
Ability to work in loud noise environments
State or Province