Remote Senior C&Q Engineer - GMP Validation Leader

Verista; United States; Remote; USD 79,000 - 114,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Employee Referral Program

Life Insurance

Job summary

Verista is seeking a Senior Validation Engineer to lead C&Q activities for GMP facilities and manufacturing systems. You will develop and execute URS, risk assessments, DQ, FAT/SAT, IQ/OQ/PQ protocols, and qualification reports, ensuring traceability and regulatory compliance.

You will coordinate field execution, punch-list management, deviations, retesting, and closeout while collaborating with Engineering, Quality, Operations, and external vendors to meet project schedules across global teams.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
• 5+ years of C&Q/CQV, commissioning, qualification, validation, or technical project execution in regulated pharma environments.
• Hands-on experience with GMP facilities, utilities, equipment, manufacturing systems, or lab systems.

Responsibilities

• Lead and support C&Q activities for GMP facilities, utilities, equipment, and systems across the project lifecycle.
• Develop and execute DQ, FAT/SAT, IQ/OQ/PQ protocols and qualification reports with traceability.
• Coordinate protocol scheduling, field execution, punch-list management, and final documentation closeout.
• Support risk-based qualification strategies per GMP, ASTM E2500, and GEP.
• Author and update C&Q procedures, protocols, and SOPs in line with Good Documentation Practices.
• Coordinate with Engineering, Quality, Operations, and vendors to align with project schedules.

Skills

Quality assurance

GMP knowledge

Regulatory compliance

Cross-functional collaboration

Documentation control

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

HP ALM/Quality Center

Jira

Veeva Vault

Documentum

Job description

Verista is seeking a Senior Validation Engineer to lead C&Q activities for GMP facilities and manufacturing systems. You will develop and execute URS, risk assessments, DQ, FAT/SAT, IQ/OQ/PQ protocols, and qualification reports, ensuring traceability and regulatory compliance.

You will coordinate field execution, punch-list management, deviations, retesting, and closeout while collaborating with Engineering, Quality, Operations, and external vendors to meet project schedules across global teams.