6514 - Project Engineer, FMEA Support / Project Engineer 2

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

The Project Engineer, FMEA will support the startup and qualification of a new pharmaceutical manufacturing facility by leading and facilitating Failure Mode and Effects Analysis (FMEA) activities. Partner with Engineering, Manufacturing, Quality, Validation, and Operations teams to identify process and equipment risks, define mitigation actions, and ensure risk controls are implemented prior to startup.

• →Facilitate FMEA/risk assessments for manufacturing equipment, utilities, processes, and facility systems.
• →Identify failure modes, assess risk, and develop appropriate mitigation and control strategies.
• →Track FMEA actions through implementation and closure.
• →Support commissioning, qualification, validation, and operational readiness activities.
• →Ensure risk assessments align with GMP, quality, and regulatory requirements.
• →Collaborate cross-functionally to resolve startup risks and improve equipment/process reliability.
• →Utilize Claude and other approved AI tools to streamline documentation, data review, risk-assessment preparation, action tracking, and routine engineering tasks while maintaining GMP and data-governance requirements.
• →Maintain clear, audit-ready FMEA and risk-management documentation

• Bachelor’s degree in Mechanical, Chemical, Electrical, Manufacturing, Facilities Engineering, or related field.
• Hands-on FMEA/risk assessment experience required.
• Experience with Facility Engineering, Maintenance, Manufacturing, or equipment/process engineering.
• Experience identifying risks, developing mitigation strategies, and tracking actions through closure.
• Experience supporting facility/equipment startup, commissioning, qualification, or operational readiness.
• Strong cross-functional communication and technical documentation skills.
• Pharmaceutical/GMP experience preferred.
• Commercial manufacturing experience preferred.
• Comfortable learning and utilizing Claude/AI tools and AI agents; direct AI-agent experience is not required.