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.National (US) Range
$85,470-$127,144 USD
BenefitsWhy Choose Verista?
- 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
