The Project Engineer will be heavily involved in capital project planning, management, and close-out for manufacturing, utility and lab area upgrades and renovations. Demonstrates the ability to successfully plan complex engineering and technology projects and sustain high quality engineering and technology contributions in a GMP environment. Interfaces with all company groups and key business partners (Viral Vector Manufacturing, Cell Therapy Processing, Plasmids Manufacturing, Testing & Analytical Services, Process Development). Proactively looks for and recommends improvements in site processes and procedures.
● Work with a cross-functional team of scientists, automation engineers, facilities staff, and operations experts to rapidly respond to evolving GMP manufacturing and laboratory utilization needs for CDMO client projects
● Incumbent coordinates development of project budgets for execution including project construction and procurement estimating. Consults with manager on development of long range capital planning and data acquisition for site master planning and program management.
● Perform functions to provide technical guidance for execution of small projects with no supervision. Make decisions independently and inform Project Leader or Sponsor of actions taken.
● Assemble and lead small project teams for capital project planning and execution
● Engagement with Facilities group to assist with identification, development, planning and delivery of expense projects and management of facilities shutdown activities.
● Solicit and manage contractors (mechanical, electrical, automation, validation, etc.) in capital project execution
● Qualify vendor, solicit bids, review bid contents, expedite equipment delivery, equipment problems communication and coordinate vendor equipment startup
● Support facility design and capital project execution projects with process input.
● Develop project management and quality project delivery procedures and adhere to relevant policies for interaction with project design (architecture & engineering firms) and delivery partners (construction managers).
Maintain high degree of familiarity on technology advancements in cell and gene therapy production processes, equipment, instrumentation and systems.
● 5+ years experience in project management for design and improvement of biopharmaceutical/ATMP manufacturing and laboratory facilities.
● Familiar with project identification & development, expedited project delivery approaches,
● Ability to combine technical knowledge and project delivery, providing the best possible project outcomes while retaining focus on cost and schedule constraints.
● Strong organizational, interpersonal, speaking and written communication skills
● Prioritizing multiple commitments and technical problem solving aptitude
● Ability to shift priorities according to changes in department/facility needs and actively consider different ideas/approaches/options.
● Knowledge of MS Project, Visio, Team and Office suite of software is a must.
● Project Management Professional (PMP) or Certified Associate in Project Management (CAPM) certification would be a plus
AutoCAD design and Bluebeam Revu PDF editing experience is a plus.
Education & Experience
● B.S. in an Engineering discipline (chemical or mechanical preferred).