Senior CQV Engineer: Lead Qualification & Validation

Verista, Inc.; Wichita (KS); On-site; USD 79,000 - 123,000; Full time

Benefits offered by this job

Health Insurance

Disability Insurance

Tuition Reimbursement

Paid Time Off

Holidays

Employee Referral Program

Job summary

Verista, Inc. is seeking a CQV professional to lead commissioning and qualification activities for life sciences facilities, utilities, and equipment.

The role requires hands-on CQV execution, strong documentation skills, and collaboration with Engineering, Quality, Operations, and vendors. The ideal candidate will have 5+ years of CQV experience in regulated environments, expertise with IQ/OQ/PQ protocols, and a solid understanding of cGMP and data integrity principles.

Qualifications

• 5+ years of hands-on CQV experience within pharmaceutical, biotechnology, medical device, or other regulated life sciences environments.
• Strong experience developing and executing IQ/OQ/PQ protocols, commissioning documentation, test scripts, and qualification reports.
• Experience with facilities, utilities, manufacturing equipment, laboratory systems, and/or computerized systems.
• Strong understanding of cGMP requirements and the equipment/system qualification lifecycle.
• Experience with deviation management, change control, punch-list management, and resolution of qualification issues.

Responsibilities

• Lead CQV activities or workstreams within large pharmaceutical or biotechnology capital projects.
• Author, review, and execute CQV documentation including URS, risk assessments, qualification plans, protocols, IQ/OQ/PQ documentation, and validation/qualification summary reports.
• Develop and execute qualification and testing activities, including IQ/OQ/PQ, functional testing, system walkdowns, field verification, punch-list management, and acceptance testing.
• Coordinate and perform hands-on field execution, ensuring protocols are followed and discrepancies are resolved in a timely manner.
• Work with Engineering, Quality, Operations, Automation, and vendors to coordinate commissioning and qualification schedules and project deliverables.

Skills

CQV experience

cGMP knowledge

Data integrity ALCOA+

Technical writing

Team leadership

Education

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

Tools

GAMP 5

ASTM E2500

Job description

Verista, Inc. is seeking a CQV professional to lead commissioning and qualification activities for life sciences facilities, utilities, and equipment.

The role requires hands-on CQV execution, strong documentation skills, and collaboration with Engineering, Quality, Operations, and vendors. The ideal candidate will have 5+ years of CQV experience in regulated environments, expertise with IQ/OQ/PQ protocols, and a solid understanding of cGMP and data integrity principles.