Commissioning & qualification Led – Job Description Summary
This job description is for a Commissioning & Qualification Lead (CQL) at Amgen, a biotechnology company.The role is focused on overseeing the C&Q (Commissioning & Qualification) activities for departmental capital projects, ensuring compliance with regulations and best practices. It’s a leadership position requiring a strong understanding of GMP, validation, and data integrity, with a focus on driving efficiency through automation and collaboration.
Here’s a breakdown of the key aspects:
Core Responsibilities:
* C&Q Oversight: Lead C&Q documentation, CCMS assessments, and ensure project alignment with C&Q standards.
* Project Support: partner with project leads to define C&Q scope, estimate effort, and allocate engineering resources.
* validation Maintenance: Manage the entire validation maintenance program – from planning and budgeting to execution and reporting.
* Inspection Readiness: Maintain inspection playbooks, address inspection findings, and present C&Q data to auditors.
* Expanding Role: Provide C&Q support to construction and capital project teams as the role evolves.
* Innovation & Efficiency: develop and implement automation/AI tools to streamline periodic reviews and audit trail assessments.
* networking & Knowledge Sharing: Participate in global C&Q networks and disseminate information to site teams.
* Deviation Management: Potentially own and manage C&Q-related deviations.
Key Skills & Experience (Summarized):
* Experience: 6-12+ years of C&Q experience (depending on education level – see “What we expect of you” section).
* GMP Knowledge: Strong understanding of Good Manufacturing Practices (GMP) regulations.
* Validation Lifecycle: Expertise in the validation lifecycle.
* Data Integrity: Solid understanding of data integrity principles.
* Leadership: Demonstrated leadership experience (preferred).
* Communication & Stakeholder Management: Excellent communication and interpersonal skills.
* Problem Solving: Strong analytical and problem-solving abilities.
* Industry Experience: Pharmaceutical, biotechnology, or regulated life sciences experience is highly desired.
* Technical Skills: Familiarity with CCMS/CMMS platforms and automation/AI tools.
What Amgen Offers:
* Competitive salary and benefits.
* Collaborative and supportive work environment.
* Opportunities for professional growth and development.
* A chance to contribute to improving patient lives.
In essence, this role is a critical leadership position responsible for ensuring the quality and compliance of capital projects within a highly regulated environment.
