Senior Validation Engineer — CQV Project Lead

Verista, Inc.; Mount Vernon (IN); On-site; USD 100,000 - 150,000; Full time

Benefits offered by this job

Company-paid Life, Short-Term, andLong

Medical, Dental & Vision Insurance

401(k) Employer Matching

Paid Time Off & Holidays

Tuition Reimbursement

Team Social Activities (We have fun!)

Job summary

Verista seeks a Senior Validation Engineer to lead end-to-end CQV/validation projects for pharmaceutical systems in Mount Vernon, IN. You will develop plans and validation deliverables, coordinate cross-functional teams, and drive regulatory-compliant testing and documentation.

The role requires extensive CQV/validation experience, GMP/GxP knowledge, and the ability to manage multiple workstreams on-site, with Veeva experience preferred.

Qualifications

• Experience leading end-to-end CQV/validation projects in regulated environments.
• Strong understanding of GMP/GxP, data integrity, and risk-based validation.
• Proven ability to manage multiple validation workstreams and deliverables.

Responsibilities

• Lead end-to-end CQV/validation projects for pharmaceutical systems from planning to closeout.
• Develop and manage Validation Plans, DQ, IQ/OQ, PQ, FAT, and commissioning documents.
• Coordinate with Engineering, Operations, Quality, and vendors to maintain schedules.
• Author protocols (FAT/IQ/OQ/PQ) and manage equipment readiness and downtime.
• Lead document reviews and manage Veeva workflows through approval cycles.
• Identify, investigate, and resolve deviations and corrective actions.
• Ensure all CQV activities comply with GxP, data integrity, and regulatory requirements.
• Serve as a senior validation lead, communicating status and risks; onsite 100% in Mount Vernon, IN.

Skills

CQV leadership

Validation project management

GxP knowledge

Data integrity

Communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Life Sciences

Tools

Veeva

Job description

Verista seeks a Senior Validation Engineer to lead end-to-end CQV/validation projects for pharmaceutical systems in Mount Vernon, IN. You will develop plans and validation deliverables, coordinate cross-functional teams, and drive regulatory-compliant testing and documentation.

The role requires extensive CQV/validation experience, GMP/GxP knowledge, and the ability to manage multiple workstreams on-site, with Veeva experience preferred.