Engineering Projects Senior Manager

<h2><b>Career Category</b></h2>Project Management<h2></h2><h2><b>Job Description</b></h2><p><span><b>Commissioning &amp; Qualification (C&amp;Q) Lead (Level 6) – Manager, C &amp; Q Center of Excellence (CoE)</b><br /><b>Summary:</b><br />The <b>C&amp;Q CoE Lead</b> provides leadership and strategic direction for the Commissioning and Qualification (C&amp;Q) activities within the broader  manufacturing operations network. This role manages a small, high-performing team responsible for delivering C&amp;Q documentation, test protocols, and execution summary reports and other C&amp;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&amp;Q Program Lead drives standardization, efficiency, and continuous improvement in C&amp;Q processes across projects and manufacturing functions.<br /><b>Key Responsibilities:</b><br /><b>Leadership &amp; Team Management</b></span></p><ul><li><span>Manage a team of C&amp;Q engineers and specialists responsible for authoring, reviewing, and commissioning and qualification lifecycle documentation.</span></li><li><span>Set clear expectations, provide mentorship, and foster a culture of accountability, technical excellence, and collaboration.</span></li><li><span>Coordinate workload and resource allocation across multiple project workstreams to ensure timely delivery of C&amp;Q milestones.</span></li><li><span>Support career development, training, and performance evaluations for direct reports.<br /><b>Program Oversight &amp; Delivery</b></span><ul><li><span>Serve as the primary C&amp;Q representative to the Capital project leadership team, ensuring alignment of C&amp;Q strategy, and prioritization with project goals, quality standards, and business needs.</span></li><li><span>Lead development and execution of the overall C&amp;Q plan, including scope definition, risk assessment, protocol strategy, and system prioritization.</span></li><li><span>Oversee generation, review, and approval of C&amp;Q documents such as User Requirements Specifications (URS), commissioning plans, qualification protocols (IQ/OQ/PQ), and summary reports.</span></li><li><span>Manage C&amp;Q schedule, budget, and resource forecasting; identify risks and implement mitigation plans proactively.</span></li><li><span>Ensure adherence to applicable global standards, Good Manufacturing Practice (GMP) regulations, and data integrity requirements.<br /><b>Process Standardization &amp; Continuous Improvement</b></span><ul><li><span>Champion the implementation and maintenance of standardized C&amp;Q practices, templates, and procedures across sites and projects.</span></li><li><span>Drive process improvements to enhance efficiency, consistency, and compliance in C&amp;Q execution.</span></li><li><span>Collaborate with cross-functional partners (Engineering, Validation, Quality, Operations, and Global Facilities Delivery) to align on best practices and lessons learned.</span></li><li><span>Contribute to global C&amp;Q governance initiatives and knowledge-sharing forums.<br /><b>Stakeholder Engagement &amp; Communication</b></span><ul><li><span>Act as the interface between the site C&amp;Q teams, project management, and quality assurance functions.</span></li><li><span>Communicate progress, risks, and key decisions to stakeholders through clear reporting and status updates.</span></li><li><span>Support quality reviews by providing subject matter expertise and ensuring documentation readiness.</span></li></ul><br /><span><b>Qualifications:</b><br /><b>Basic Qualifications</b></span><ul><li><span>Bachelor’s degree in Engineering, Life Sciences, or a related technical field.</span></li><li><span>7&#43; years of experience in commissioning, qualification, or validation in a GMP-regulated environment.</span></li><li><span>Demonstrated leadership experience, including direct people management or technical team leadership.</span></li></ul><br /><span><b>Preferred Qualifications</b></span><ul><li><span>Master’s degree in Engineering or related discipline.</span></li><li><span>Experience leading C&amp;Q activities for large-scale capital projects (biotech, pharmaceutical, or sterile manufacturing preferred).</span></li><li><span>Strong understanding of ASTM E2500, ISPE Baseline Guides, GAMP principles, and FDA/EMA regulatory expectations.</span></li><li><span>Proven track record of implementing process improvements and standardization initiatives.</span></li><li><span>Excellent organizational, communication, and stakeholder management skills.</span></li><li><span>Ability to work effectively in a matrixed, cross-functional, and fast-paced environment.</span></li></ul><br /><span><b>Competencies:</b></span><ul><li><span>Strategic Thinking and Decision-Making</span></li><li><span>Technical Expertise in C&amp;Q and Validation Science</span></li><li><span>Leadership and Talent Development</span></li><li><span>Continuous Improvement and Innovation</span></li><li><span>Collaboration and Influence</span></li><li><span>Project Management and Execution Excellence</span></li></ul></li></ul></li></ul></li></ul><p style="text-align:inherit"></p><p style="text-align:inherit"></p><p style="text-align:inherit"></p>.