Job Information
Amgen Engineering Projects Senior Manager in Hyderabad, India
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