Senior Engineer - Project Engineering

• Serve as Qualification Lead for departmental capital projects, overseeing contracted resources, documentation, CCMS assessments, and project alignment
• Partner with project leads to scope new work, estimate efforts, and assign engineering resources
• Manage the full lifecycle of the validation maintenance program, including development of the annual scope of work, cost negotiations, PO issuance, and leading progress meetings
• Drive inspection readiness by maintaining playbooks, responding to inspection IRFs, and presenting qualification topics to auditors
• Support construction and capital project teams by providing oversight as the role continues to expand
• Lead efficiency improvements by developing automation/AI tools for periodic reviews and audit trail assessments
• Participate in global qualification, computerized systems, and data integrity networks and share updates with site teams
• May own and manage deviations as assigned

• High school diploma / GED and 12 years of Project Implementation and Qualification experience
• Associate’s degree and 10 years of Project Implementation and Qualification experience
• Bachelor’s degree and 6 years of Project Implementation and Qualification experience
• Master’s degree and 4 years of Project Implementation and Qualification experience
• Doctorate degree and 4 years of Project Implementation and Qualification experience

• Demonstrated leadership experience in managing technical teams or leading complex cross-functional initiatives
• Strong understanding of GMP regulations, validation lifecycle requirements, data integrity principles, and qualification best practices
• Experience serving as a project or qualification lead on capital projects
• Ability to interface with auditors and respond to regulatory inspection requests
• Familiarity with automated systems, CCMS/CMMS platforms, and AI/automation tools for compliance workflows
• Excellent communication, stakeholder engagement, and decision-making skills
• Ability to manage competing priorities in a dynamic environment and influence without authority
• Strong analytical skills and ability to translate technical data into clear, actionable insights
• Prior experience within the pharmaceutical, biotechnology, or regulated life sciences industry strongly desired

competitive and comprehensive Total Rewards Plans that are aligned with local industry standards