Senior CQV/Validation Lead - Strategy & Execution

Verista; Wichita (KS); Hybrid; USD 91,000 - 136,000; Full time

Benefits offered by this job

Competitive pay

Health Insurance

401(k) Matching

Job summary

Verista, a leader in life sciences solutions, seeks a Senior Validation Engineer to lead CQV efforts across facilities, utilities, and laboratory systems. You will author and execute validation deliverables, drive risk-based validation, and coordinate cross-functional teams to ensure compliance with cGMP and regulatory standards.

The role requires 7+ years in validation, strong leadership, and experience with IQ/OQ/PQ protocols, project management, and vendor coordination.

Qualifications

• Bachelor's degree in engineering or life sciences.
• 7+ years in validation/CQV within regulated life sciences.
• Experience authoring and executing validation deliverables.
• Proven IQ/OQ/PQ protocol development and testing.
• Strong knowledge of cGMP, GAMP 5, FDA/EMA expectations.
• Experience leading validation across equipment, facilities, automation, or computerized systems.
• Vendor coordination and cross-functional project leadership.

Responsibilities

• Lead and execute validation activities for facilities, equipment, and systems in GxP environments.
• Author, review, and approve validation deliverables (URS, plans, protocols, reports).
• Coordinate hands-on validation execution and testing.
• Act as technical lead for validation strategy and execution.
• Collaborate with Engineering, Quality, Operations, IT, and vendors to meet milestones.
• Review drawings, specs, and commissioning records to define validation needs.
• Lead deviation/change control resolution in validation.
• Ensure compliance with cGMP, GAMP 5, data integrity principles.

Skills

Validation leadership

Project coordination

Regulatory knowledge

GxP compliance

Cross-functional collaboration

Education

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

Tools

Microsoft Project

Smartsheet

Jira

Job description

Verista, a leader in life sciences solutions, seeks a Senior Validation Engineer to lead CQV efforts across facilities, utilities, and laboratory systems. You will author and execute validation deliverables, drive risk-based validation, and coordinate cross-functional teams to ensure compliance with cGMP and regulatory standards.

The role requires 7+ years in validation, strong leadership, and experience with IQ/OQ/PQ protocols, project management, and vendor coordination.