Facility Project Engineer

Raleigh, USA

The Facility Project Engineer will be responsible for executing the major elements of Cellectis US manufacturing operations strategy and provides lifecycle project management expertise to the site. This role will be a lead contributor to the initial site establishment, transfer and production start-up. This position will act as the principal lead and provide technical leadership (i.e. engineering design and construction expertise) on facility systems and infrastructure projects.

This role will be accountable for developing project scopes/plans, schedule and budget requirements, and risk/issue management as well as specification, purchase, installation and qualification of production, facility and automation equipment and systems. The Facility Project Engineer ensures that systems and field work is completed in accordance with engineering drawings, specifications and company design strategy and provides troubleshooting support when needed.

Published on October 16, 2019

RESPONSIBILITIES:

  • Develops, plans and manages all aspects of the project delivery process from scope definition, validation and planning to completion. Defines the scope, business drivers, quality objectives, financial impact, key activities, evaluation methods, and time lines.
  • Identifies, negotiates and manages external construction/engineering contractors, vendors and manufacturers to support project delivery. Ensures design and construction meets regulatory codes and standards as well as company standards.
  • Leads and supervises project team. Determines project team members, roles and assigns work responsibilities.
  • Works closely with key stakeholders (i.e.: Validation Manager, Manufacturing, Quality) to ensure completion of commissioning, turnover and closeout activities, including acceptance testing, training, corrective work, etc.
  • Supports manufacturing, facility and utility operations in troubleshooting and resolving complex technical issues, root cause analysis and implementing effective corrective actions.
  • Consults with, advises and provides regular communications updates and reports to key project stakeholders and management.
  • Acts as a technical subject matter expert on pharmaceutical manufacturing equipment and systems.
  • Initiates and implements process improvement systems and projects for ongoing growth and sustainability, cost containment/reduction, and/or quality improvement.
  • Provides subject matter expertise during regulatory inspections and interact with auditors as necessary.
  • Supports the development of long-range plans for site infrastructure, compliance, modernization and manufacturing efficiencies.
  • Assures all system and equipment changes utilize proper cGMP documentation such as change control and maintenance work requests.
  • Generates, reviews, and assists with project documents ensuring technical accuracy and cGMP compliance (i.e. URS / Design documents, Change Controls, Validation, SOP’s, Maintenance Plans, FAT’s, SAT’s, qualification/validation protocols etc.)
  • Responsible for selection and implementation of project management tools and systems (i.e.: MS Project) to manage, monitor and track project progress, budget, timeline and for report generation.
  • Leads by example and advocates company goals for environmental, health and safety policies and programs.
  • Gathers on-going industry knowledge and stays abreast of current industry standards (i.e. GMP, GxP). Maintains PMP credentials as required.

POSITION REQUIREMENTS:

  • Bachelor’s Degree in Engineering discipline.
  • 5+ years of project management experience in biotech/pharmaceutical. Experience with new establishment, tech transfer and production start-up preferable.
  • Certified Project Management Professional (PMP) is a plus. Professional Engineering certification a plus.
  • Lean Sigma/Green Belt Certification desired.
  • Knowledge of cGMP’s, principles of validation and FDA requirements.
  • Demonstrated knowledge of facility/plant systems and infrastructure including:  mechanical, electrical and controls to fully understand overall system designs and functionality for making sound decisions.
  • Skilled at reading and interpreting various standards, drawings, diagrams, and schematics.
  • Experience working with third party suppliers, contractors, technical staff and similar resources and skilled at negotiating terms and agreements.
  • Capacity to work well under pressure with tight timelines. Able to adapt and manage multiple projects and tasks simultaneously.
  • Demonstrated initiative and analytical problem-solving skills. Ability to use and interpret data to drive decision making at both tactical and strategic level.
  • Proven leadership abilities to achieve cooperative and effective performance from project team.
  • Excellent written and verbal communications with ability to influence effectively at all levels within organization. Presentations skills required.
  • Excellent in MS-Office, MS-Project, ERP systems and AutoCad.