Remote Senior C&Q Engineer – GMP Validation Expert

Verista, Inc.; Harvard (MA); On-site; USD 79,000 - 114,000; Full time

Benefits offered by this job

Health Insurance

Life Insurance & Disability

Tuition Reimbursement

Paid Time Off

Health Savings Account

Parental Leave

Job summary

Verista is seeking a senior C&Q/QV professional to lead commissioning and qualification across GMP facilities and systems. You will author, review, and execute URS, DQ, FAT/SAT, IQ/OQ/PQ protocols and qualification reports, coordinating with engineering, QA, and operations globally.

The role requires 5+ years in C&Q, GMP, and validated environments, with hands-on experience and strong documentation practices. Remote work with occasional client-site travel is possible.

Qualifications

• Bachelor’s degree in engineering, life sciences, or related technical field.
• 5+ years in C&Q/CQV, commissioning or validation in regulated life sciences.
• Hands-on commissioning/qualification of GMP facilities and systems.
• GMP/GEP/ASTM E2500 knowledge and good documentation practices.
• Experience authoring and executing C&Q protocols and reports.

Responsibilities

• Lead and coordinate commissioning and qualification activities across projects.
• Develop, review, and execute URS, DQ, FAT/SAT, IQ/OQ/PQ and SOPs.
• Manage test evidence, traceability, deviations, and closeout documentation.
• Collaborate with Engineering, QA, Operations, and vendors globally.

Skills

C&Q/CQV methodologies

GMP familiarity

Kneat power user

Documentation & SOP writing

Cross-functional coordination

Change control & deviations

Traceability & risk assessment

Project management tools

Education

Bachelor’s degree in Engineering or Life Sciences

Tools

Jira

HP ALM/Quality Center

Kneat

Veeva Vault

Documentum

Job description

Verista is seeking a senior C&Q/QV professional to lead commissioning and qualification across GMP facilities and systems. You will author, review, and execute URS, DQ, FAT/SAT, IQ/OQ/PQ protocols and qualification reports, coordinating with engineering, QA, and operations globally.

The role requires 5+ years in C&Q, GMP, and validated environments, with hands-on experience and strong documentation practices. Remote work with occasional client-site travel is possible.