6514 - Project Engineer, FMEA Support / Project Engineer 2
About The Position
Verista is seeking a Project Engineer, FMEA to support the startup and qualification of a new pharmaceutical manufacturing facility. This role involves leading and facilitating Failure Mode and Effects Analysis (FMEA) activities. The Project Engineer will 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. Verista is a company with 500 experts that collaborates with recognizable brands in the life science industry to solve business needs, empower growth and innovation, and address healthcare challenges. The company emphasizes a people-focused culture, client success, integrity, inclusivity, and continuous learning.
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.
- Comfortable learning and utilizing Claude/AI tools and AI agents; direct AI-agent experience is not required.
Nice To Haves
- Pharmaceutical/GMP experience preferred.
- Commercial manufacturing experience preferred.
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.
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
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
