I: Job Summary

Lead engineering, maintenance, metrology, site planning at the Camden campus. Heavy focus on personnel/team development, performance management, and client/regulatory facing (process equipment/systems operation)

II: Essential Functions

• Provide leadership and supervision for the activities of the engineering, maintenance, and support personnel including:
  • Teambuilding
  • Exemplify strong and effective communication
  • Constructive and goals-based feedback
  • Employee tailored personnel development
  • Motivation and empowerment of direct/indirect reports to ensure the safe and effective acquisition/use/maintenance of site systems
  • Priority management
  • Conflict resolution
• Ensure the effective operation of the sites CAD services and the drawing management system. Outsource non-controlled drawing revisions to pre-qualified, third party CAD service providers
• Procure, coordinate the qualification of, and manage vendors
• Oversee the execution of the capital project portfolio managed by Facilities/ Maintenance
• Lead or participate in continuous improvement initiatives
• Supervise metrology program to ensure calibration of facility/process instrumentation
• Oversee the execution, and the development, of lyophilization cycles
• Preventive maintenance program continuous improvement
• Technical support and troubleshooting assistance to facilities and production personnel on technical issues that are beyond the training or experience of those organizations
• Plan, schedule, and coordinate the technicians for project support or facilities tasks

The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

• Bachelor of Science degree in Engineering or related discipline
• Eight years experience in a pharmaceutical/process industry setting
• Detailed knowledge of facilities, systems, and infrastructure within an industrial setting
• Knowledge of CAD software and drawing management
• Strong oral, written, and listening communication skills
• Proficient with Microsoft Office tools
• Demonstrated ability to:
  • • • provide clear direction and motivate teams
      • lead by example through strong work ethics and high standards
      • be hands-on and available during off-hours
      • work as a team leader or as a team member
      • influence other individuals and departments
      • adapt quickly to changing priorities
      • continue to improve skills through professional development

Advanced Requirements:

• Working knowledge of SAP
• Familiarity with FDA regulations relating to biologic and drug products
• Familiarity with FDA current Good Manufacturing Practices
• Advanced training in engineering, business or project management
• Member of PMI, ISPE, ASME, or AICHE

• EIT, PE, CAPM, PMP or LEED certification
• Familiar with pharmaceutical industry guidelines such as ISPE Baseline Guides, ISO and ASME BPE