6514 - Project Engineer, FMEA Support / Project Engineer 2

Verista; Indianapolis (IN); Presencial; USD 85.000 - 127.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

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

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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

Conocimientos

FMEA/Risk assessment

Cross-functional communication

Risk mitigation

Documentation skills

Startup/commissioning support

Educación

Bachelor's degree in Engineering

Herramientas

Claude/AI tools

Descripción del empleo

Description

Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values

• 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.

Project Engineer FMEA Support Responsibilities

• 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

Requirements

• 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.

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future. *Verista is an equal opportunity employer.

National (US) Range: $85,470 USD - $127,144 USD

Benefits

• High growth potential and fast-paced organization with a people-focused culture
• Competitive pay plus performance-based incentive programs
• Company-paid Life, Short-Term, and Long-Term Disability Insurance.
• Medical, Dental & Vision insurances
• FSA, DCARE, Commuter Benefits
• Supplemental Life, Hospital, Critical Illness and Legal Insurance
• Health Savings Account
• 401(k) Retirement Plan (Employer Matching benefit)
• Paid Time Off (Rollover Option) and Holidays
• As Needed Sick Time
• Tuition Reimbursement
• Team Social Activities (We have fun!)
• Employee Recognition
• Employee Referral Program
• Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com