FMEA Project Engineer for GMP Facility Startup

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

Benefits offered by this job

Competitive pay

Company-paid benefits

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Job summary

Verista, Inc. is seeking a Project Engineer FMEA to support the startup of a new pharmaceutical manufacturing facility. You will lead and facilitate FMEA activities across engineering, manufacturing, quality, validation and operations to identify risks and define mitigations.

You will track actions through closure, ensure GMP alignment, and collaborate cross-functionally to improve equipment and process reliability. Experience with FMEA, GMP, and facility startup is preferred.

Qualifications

• Bachelor’s degree in Mechanical, Chemical, Electrical, Manufacturing, Facilities Engineering or related field.
• Hands-on FMEA/risk assessment experience required.
• Experience supporting facility startup, commissioning, qualification, or operational readiness.

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

Facility engineering

Cross-functional communication

Documentation & GMP

Claude/AI tool familiarity

Education

Bachelor’s degree in Mechanical, Chemical, Electrical, Manufacturing, or Facilities Engineering

Tools

Claude/AI tools

Job description

Verista, Inc. is seeking a Project Engineer FMEA to support the startup of a new pharmaceutical manufacturing facility. You will lead and facilitate FMEA activities across engineering, manufacturing, quality, validation and operations to identify risks and define mitigations.

You will track actions through closure, ensure GMP alignment, and collaborate cross-functionally to improve equipment and process reliability. Experience with FMEA, GMP, and facility startup is preferred.