Engineering Projects Senior Manager

Commissioning & Qualification (C&Q) Lead (Level 6) – Manager, C & Q Center of Excellence (CoE)
Summary:
The C&Q CoE Lead provides leadership and strategic direction for the Commissioning and Qualification (C&Q) activities within the broader  manufacturing operations network. This role manages a small, high-performing team responsible for delivering C&Q documentation, test protocols, and execution summary reports and other C&Q lifecycle documents  to ensure facility, utility, and equipment systems are fit for intended use and compliant with internal standards and regulatory expectations. The C&Q Program Lead drives standardization, efficiency, and continuous improvement in C&Q processes across projects and manufacturing functions.
Key Responsibilities:
Leadership & Team Management

• Manage a team of C&Q engineers and specialists responsible for authoring, reviewing, and commissioning and qualification lifecycle documentation.
• Set clear expectations, provide mentorship, and foster a culture of accountability, technical excellence, and collaboration.
• Coordinate workload and resource allocation across multiple project workstreams to ensure timely delivery of C&Q milestones.
• Support career development, training, and performance evaluations for direct reports.
  Program Oversight & Delivery
  • Serve as the primary C&Q representative to the Capital project leadership team, ensuring alignment of C&Q strategy, and prioritization with project goals, quality standards, and business needs.
  • Lead development and execution of the overall C&Q plan, including scope definition, risk assessment, protocol strategy, and system prioritization.
  • Oversee generation, review, and approval of C&Q documents such as User Requirements Specifications (URS), commissioning plans, qualification protocols (IQ/OQ/PQ), and summary reports.
  • Manage C&Q schedule, budget, and resource forecasting; identify risks and implement mitigation plans proactively.
  • Ensure adherence to applicable global standards, Good Manufacturing Practice (GMP) regulations, and data integrity requirements.
    Process Standardization & Continuous Improvement
    • Champion the implementation and maintenance of standardized C&Q practices, templates, and procedures across sites and projects.
    • Drive process improvements to enhance efficiency, consistency, and compliance in C&Q execution.
    • Collaborate with cross-functional partners (Engineering, Validation, Quality, Operations, and Global Facilities Delivery) to align on best practices and lessons learned.
    • Contribute to global C&Q governance initiatives and knowledge-sharing forums.
      Stakeholder Engagement & Communication
      • Act as the interface between the site C&Q teams, project management, and quality assurance functions.
      • Communicate progress, risks, and key decisions to stakeholders through clear reporting and status updates.
      • Support quality reviews by providing subject matter expertise and ensuring documentation readiness.
      
      Qualifications:
      Basic Qualifications
      • Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
      • 7+ years of experience in commissioning, qualification, or validation in a GMP-regulated environment.
      • Demonstrated leadership experience, including direct people management or technical team leadership.
      
      Preferred Qualifications
      • Master’s degree in Engineering or related discipline.
      • Experience leading C&Q activities for large-scale capital projects (biotech, pharmaceutical, or sterile manufacturing preferred).
      • Strong understanding of ASTM E2500, ISPE Baseline Guides, GAMP principles, and FDA/EMA regulatory expectations.
      • Proven track record of implementing process improvements and standardization initiatives.
      • Excellent organizational, communication, and stakeholder management skills.
      • Ability to work effectively in a matrixed, cross-functional, and fast-paced environment.
      
      Competencies:
      • Strategic Thinking and Decision-Making
      • Technical Expertise in C&Q and Validation Science
      • Leadership and Talent Development
      • Continuous Improvement and Innovation
      • Collaboration and Influence
      • Project Management and Execution Excellence