Pharma Project Engineer — FMEA & Startup Readiness

Verista; Indianapolis (IN); Hybride; USD 85 000 - 127 000; Plein temps

Avantages offerts par ce poste

Health Savings Account

Paid Time Off and Holidays

Tuition Reimbursement

Life Insurance (Company-paid)

Disability Insurance (Long/Short-Term)

Employee Referral Program

Résumé du poste

Verista, located in Indianapolis, IN, seeks a Project Engineer focused on FMEA to lead risk assessments for new pharmaceutical facility startup. You will partner with Engineering, Manufacturing, Quality, Validation, and Operations to identify risks, define mitigations, and ensure controls are implemented prior to startup.

Responsibilities include facilitating FMEA activities, tracking actions to closure, supporting commissioning and qualification, and maintaining audit-ready documentation while

Qualifications

• Hands-on FMEA and 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.
• GMP/pharma experience preferred.
• Commercial manufacturing experience preferred.
• Comfortable learning and utilizing Claude/AI tools and AI agents; direct AI-agent experience is not required.

Responsabilités

• 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

Connaissances

FMEA/Risk assessment

Cross-functional comms

Technical documentation

GMP experience

AI tooling familiarity

Formation

Bachelor’s degree in Mechanical, Chemical, Electrical, Manufacturing, Facilities Eng

Outils

Claude AI tools

Description du poste

Verista, located in Indianapolis, IN, seeks a Project Engineer focused on FMEA to lead risk assessments for new pharmaceutical facility startup. You will partner with Engineering, Manufacturing, Quality, Validation, and Operations to identify risks, define mitigations, and ensure controls are implemented prior to startup.

Responsibilities include facilitating FMEA activities, tracking actions to closure, supporting commissioning and qualification, and maintaining audit-ready documentation while