PRINCIPAL PROJECT ENGINEER

Biotechnology Company

Pharmaceutical Manufacturing

Summary:

Provides management of individual projects associated with new or improved facilities, infrastructure, utilities, and process equipment.  Establish and lead cross-functional teams in budgeting, designing, planning, and managing projects from conceptualization through completion.  Directly manages project engineers and engineering support groups as required by project scope.  Ensure all company, local, state, and federal regulatory requirements are met.

Specifically seeking:

·         Mechanical Engineering background

·         Prefer strong background in Six Sigma, Lean Manufacturing and/or Continuous/Process Improvement

·         Background in manufacturing environment (preferably experience with packaging equipment)

·         Will start out managing capital projects and then will focus on Six Sigma or Continuous Improvement projects on the engineering and maintenance side

Functions:

• Create and execute project work plans revising as appropriate to meet challenging needs as requirements.
  
• Manage day to day operational aspects of a given project and scope.
  
• Accountable for rigorously controlling project cost, schedule, safety, quality, deliverables and project systems.
  
• Prepare budgetary estimates, schedules, cash flow projections, and justifications for capital approval
  
• Prepare and manage department and project budgets
  
• Interview, select, manage and coordinate the efforts of design and construction firms as appropriate
  
• Understand and create URS and design specification documents
  
• Manage critical design decisions and maintain limits on project scope of work
  
• Specify and procure major equipment item for utility and processing systems.
  
• Coordinate and manage commissioning and qualification activities for equipment and facilities.
  
• Maintain verbal and written communications with project stakeholder’s at all organizational levels.
  
• Continuously prepare and adapt a risk mitigation plans during all phases of assigned projects
  
• Motivate project teams and direct reports to work together in the most efficient manner
  
• Mitigate perceived team conflict and communication issues
  
• Ensure all activities are conducted within the safety guidelines of the company and established governmental entities
  
• Provide leadership, direction and guidance to direct reports and contractors
  
• Establish and maintain cooperative working relationships with those contacted in the course work

Requirements:

• BS Engineering Manufacturing or equivalent
  
• 10 years related experience in Pharmaceutical, Biological, or Manufacturing environment
  
• Solid knowledge of quality systems, overseeing agency requirements, aseptic design and philosophy
  
• Knowledge of construction/operation/ manufacturing principals, cGMPs, FDA, EU, DEA, OSHA, and EPA
  
• 6 years related experience/ 2 years validation experience in pharmaceutical or related industry.