Pharma Project Engineer: FMEA & Startup Readiness

Verista; Indianapolis (IN); On-site; USD 85,000 - 127,000; Full time

Benefits offered by this job

Growth potential

Performance-based incentives

Life insurance

Medical, Dental & Vision

401(k) matching

Paid time off

Tuition reimbursement

Parental leave

Bereavement leave

Team events

Employee recognition

Referral program

Commuter benefits

Job summary

Verista seeks a Project Engineer FMEA to lead Failure Mode and Effects Analysis during startup of a new pharmaceutical facility. You will partner with Engineering, Manufacturing, Quality, Validation, and Operations to identify risks and implement controls.

You will facilitate risk assessments, track actions, and ensure GMP alignment while using approved AI tools. Strong documentation and cross-functional teamwork are essential.

Qualifications

• Hands-on FMEA/risk assessment experience required.
• Experience in Facility Engineering, Maintenance, Manufacturing, or equipment/process engineering.
• Experience identifying risks, developing mitigation strategies, and tracking actions through closure.
• Experience supporting facility startup, commissioning, qualification, or operational readiness.
• Strong cross-functional communication and technical documentation skills.
• Pharmaceutical/GMP experience preferred.

Responsibilities

• Facilitate FMEA/risk assessments for manufacturing equipment, utilities, processes, and facility systems.
• Identify failure modes, assess risk, and develop 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

Skills

FMEA/Risk assessment

Cross-functional communication

Risk mitigation

Documentation skills

Startup/commissioning support

Education

Bachelor's degree in Engineering

Tools

Claude/AI tools

Job description

Verista seeks a Project Engineer FMEA to lead Failure Mode and Effects Analysis during startup of a new pharmaceutical facility. You will partner with Engineering, Manufacturing, Quality, Validation, and Operations to identify risks and implement controls.

You will facilitate risk assessments, track actions, and ensure GMP alignment while using approved AI tools. Strong documentation and cross-functional teamwork are essential.