Validation Project Engineer

5 days ago

New Brunswick, New Jersey, United States PSC Biotech Full time
About the Role

PSC Biotech is seeking an experienced and motivated Validation Project Engineer to plan, execute, and manage CQV projects, manage vendors, and provide technical review. This role will drive successful project and deliverable completion, adhering to industry standards and regulations.

Key Responsibilities
  • Drive project success by assessing priorities and project plans, schedule, and budget, and ensure timely and effective resolution of potential risks and issues.
  • Assist in the development of CQV project planning in accordance with project design documentation, equipment specifications, etc.
  • Identify and develop the scope of work required per system (including loop checks, hardware checkouts, other related CQV tasks).
  • Oversee and track the development of user requirements documentation on a system-by-system basis.
  • Collaborate with technical teams, contractors, and equipment vendors to develop system lists and system boundaries.
  • Coordinate instrument and equipment checkout activities.
  • Oversee calibration requirements with instrumentation contractors.
  • Serve as liaison between vendors and contractors, coordinating required handoffs.
  • Manage and review vendor contracts (review timesheets, earned value, project scope changes, etc.).
  • Support the development of proposal writing for contracting and CQV resources.
  • Ensure effective and active communication with stakeholders, project managers on all project updates, progress, risks, resolutions, budget, contractor, and vendor statuses, change requests, and so on.
  • Elevate any potential risks or issues to upper management and determine any potential delays in deliverables.
  • Ensure all required documentation is recorded in a timely and efficient manner and meets regulatory and quality guidelines.
  • Lead meetings with project managers and team members as needed.
Requirements
  • Bachelor's degree in engineering or related technical field.
  • 5 years of CQV experience in a regulated GMP environment.
  • Experienced with facility buildout requirements and project planning.
  • Experience managing equipment and instrumentation contractors and vendors.
  • Experience supporting proposal writing.
  • Strong understanding of regulatory requirements (FDA, EMA, ICH, etc.) and industry standards (GMP, GLP, GAMP, etc.) related to CQV.
  • Experience with risk assessment methodologies (e.g., FMEA) and root cause analysis.
  • Excellent project management skills, including the ability to develop and manage project plans, schedules, and budgets.
  • Exceptional attention to detail and the ability to review technical documentation thoroughly.
  • Effective communication and interpersonal skills, enabling collaboration with diverse cross-functional teams.
  • Travel is required.

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