Remote Senior C&Q Engineer – GMP Validation

Veristainc; Harvard (MA); Remote; USD 79,000 - 114,000; Full time

Benefits offered by this job

Competitive pay

Health insurance

401(k) matching

Paid time off

Job summary

Verista is seeking an experienced Senior Validation Engineer for a fully remote US-based role. You will lead C&Q activities for GMP facilities, ensuring compliance with regulatory standards and industry best practices.

You will develop and manage qualification deliverables, coordinate cross-functional teams, and support digital C&Q platforms to accelerate project turnover while maintaining quality and traceability.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 5+ years of experience in C&Q/CQV, commissioning, qualification, validation in regulated life sciences environments.
• Hands-on experience with GMP facility, utilities, equipment, or lab system qualification.

Responsibilities

• Lead and support C&Q activities for GMP facilities and manufacturing systems across project lifecycles.
• Develop, review, and execute C&Q deliverables: URS, DQ, FAT/SAT, IQ/OQ/PQ, and qualification reports.
• Coordinate protocol scheduling, field execution, punch-list management, deviations, retesting, and closeout.
• Support development of risk-based qualification strategies per GMP, ASTM E2500, and GEP.
• Author and update C&Q docs, templates, and test scripts per Good Documentation Practices.
• Manage C&Q documentation through electronic systems with proper traceability and lifecycle control.
• Support digital C&Q execution using Kneat or similar platforms.

Skills

Stakeholder management

Communication skills

Problem solving

Documentation

Project coordination

Education

Bachelor’s degree in Engineering, Life Sciences

Tools

Kneat

HP ALM/Quality Center

Jira

Documentum

Veeva Vault

Job description

Verista is seeking an experienced Senior Validation Engineer for a fully remote US-based role. You will lead C&Q activities for GMP facilities, ensuring compliance with regulatory standards and industry best practices.

You will develop and manage qualification deliverables, coordinate cross-functional teams, and support digital C&Q platforms to accelerate project turnover while maintaining quality and traceability.