CQV/CSV Senior Project Manager

Wunderlich-Malec Engineering-posted 3 months ago
Full-time • Mid Level
Portsmouth, NH
Professional, Scientific, and Technical Services
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Wunderlich-Malec Engineering (WM) is a 100% employee-owned ESOP and one of the largest and most well-established engineering companies in the United States. When you join WM you become part of a company that is: - 100% employee-owned with 40+ years of industry history - A Top 5 Systems Integrator Giant - ENR Top 500 Firm We have a CQV/CSV Senior Project Manager Opportunity in Portsmouth, NH. The ideal candidate will bring extensive experience leading commissioning, qualification, validation, and computer system validation initiatives for capital projects in the life sciences industry.

  • Lead and manage the end-to-end lifecycle of CQV and CSV projects, from planning through execution and closure.
  • Develop and implement project execution plans, commissioning and validation master plans, and associated project documentation in alignment with cGMP requirements.
  • Oversee creation, review, and approval of user requirements, functional specifications, and test protocols (IQ, OQ, PQ).
  • Manage project schedules, budgets, risks, and resource allocation to ensure delivery of milestones on time and within budget.
  • Direct and coordinate internal teams, contractors, and vendors in the execution of CQV/CSV activities.
  • Guide clients in strategic decision-making, balancing compliance, quality, cost, and schedule considerations.
  • Ensure project deliverables meet regulatory, business, and technical expectations.
  • Maintain consistent communication with clients and internal leadership on progress, issues, and resolutions.
  • Act as the client's representative when required, managing third parties and ensuring alignment with project objectives.
  • Provide leadership and direction for small to large, highly complex, multi-disciplinary CQV and CSV projects.
  • Build and mentor high-performing project teams to deliver against goals and regulatory expectations.
  • Develop strong vendor and client relationships to ensure service excellence and trust.
  • Collaborate across engineering, automation, quality, and IT functions to ensure seamless project execution.
  • Uphold accountability for overall project and program success, driving both compliance and business value.
  • Bachelor's degree (preferably Engineering, Construction Management or related field).
  • 3+ years as a capital Project Manager within the Life Sciences industry.
  • 3+ years hands-on CQV/CSV execution experience.
  • Experience in life sciences required.
  • Exemplary communication skills.
  • Consistently maintains a positive and encouraging attitude.
  • Forward-looking and focused on the best resolution.
  • Proactively seeks and accepts new challenges.
  • Organized and prompt.
  • Servant leader, focused on leadership and advocating for their people before themselves.
  • PMP certification beneficial.
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