Verista

6495 - Senior CQV Engineer / Senior Validation Engineer

Verista • $78K — $110K *
Mount Vernon, IN 47620In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Life Sciences, or related field
  • 5+ years of relevant experience in CQV or validation
  • Experience leading end-to-end CQV/validation projects
  • Hands-on development and execution of key validation documents
  • Strong understanding of GMP, GxP, and regulatory requirements
  • Familiarity with Veeva or similar document management systems
  • Proven project management and communication skills

Responsibilities

  • Lead CQV and validation projects from planning to closeout
  • Develop and manage core validation deliverables
  • Collaborate with cross-functional teams to maintain schedules
  • Author and execute commissioning protocols and tests
  • Manage validation document reviews and resolution
  • Identify and resolve validation-related issues
  • Ensure compliance with GxP/cGMP and regulatory standards
  • Communicate project status and manage multiple workstreams independently

Benefits

  • High growth potential in a people-focused culture
  • Performance-based incentive programs
  • Company-paid disability insurance
  • Comprehensive health insurance plans
  • Flexible spending and commuter benefits
  • 401(k) plan with employer matching
  • Generous paid time off and holidays
  • Tuition reimbursement for ongoing education
  • Supported team social activities
  • Employee recognition and referral programs
  • Paid parental leave and bereavement support
Full Job Description
Senior Validation Engineer Responsibilities:
  • Lead and drive end-to-end CQV and validation projects for pharmaceutical manufacturing, facility, utility, and equipment systems, from planning through execution, closeout, and final approval
  • Develop, review, and manage core validation deliverables, including Validation Plans, DQ, Data Integrity Assessments, FAT, IQ/OQ, PQ, Commissioning, Validation Reports, and associated summaries
  • Partner with Engineering, Project Management, Operations, Quality, SMEs, and vendors to define requirements, coordinate project activities, manage dependencies, and maintain validation schedules
  • Author and execute FAT, IQ/OQ, PQ, and Commissioning protocols, coordinating equipment availability, personnel, materials, calibrations, and required downtime to support successful testing
  • Lead validation document reviews, consolidate and resolve comments, and manage Veeva or comparable document management workflows through pre-approval, execution, and final approval
  • Identify, investigate, and resolve deviations, exceptions, discrepancies, and testing issues, coordinating corrective actions, approvals, and required retesting
  • Ensure all CQV activities and documentation comply with GxP/cGMP, data integrity, risk-based validation principles, company procedures, and applicable regulatory requirements
  • Serve as a senior validation lead, proactively communicating project status, risks, schedule impacts, and critical issues, while independently managing multiple CQV workstreams and driving projects to successful completion

Job Requirements:
  • Bachelor's degree in Engineering, Life Sciences, or a related technical discipline
  • 5+ years of experience in CQV, validation, commissioning, or engineering within pharmaceutical, biotechnology, or other regulated industries
  • Demonstrated experience leading end-to-end CQV/validation projects, including planning, document development, execution, issue resolution, and validation closeout
  • Strong hands-on experience developing and executing DQ, DIA, FAT, IQ/OQ, PQ, commissioning, Validation Plans, and Validation Reports for equipment, utilities, facilities, or manufacturing systems
  • Proven ability to drive cross-functional validation activities, coordinating Project Management, Engineering, Operations, Quality, SMEs, vendors, and other stakeholders to maintain schedules and resolve issues
  • Strong understanding of GMP, GxP, data integrity, risk-based validation, qualification principles, and applicable regulatory requirements
  • Experience with Veeva or comparable electronic document management/quality systems, including document routing, review, comment resolution, approval, and validation record management
  • Strong project management, communication, organizational, troubleshooting, and leadership skills, with the ability to independently manage multiple validation workstreams and deliverables in a fast-paced regulated environment
  • Must be willing to be on-site 100% in Mount Vernon, IN


For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

National (US) Range

$78,925-$110,000 USD

Benefits

Why Choose Verista?
  • High growth potential and fast-paced organization with a people-focused culture
  • Competitive pay plus performance-based incentive programs
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance.
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Supplemental Life, Hospital, Critical Illness and Legal Insurance
  • Health Savings Account
  • 401(k) Retirement Plan (Employer Matching benefit)
  • Paid Time Off (Rollover Option) and Holidays
  • As Needed Sick Time
  • Tuition Reimbursement
  • Team Social Activities (We have fun!)
  • Employee Recognition
  • Employee Referral Program
  • Paid Parental Leave and Bereavement

For more information about our company, please visit us at Verista.com

About Verista

Verista is a software company that provides a platform for managing and automating business processes. The company's platform uses artificial intelligence and machine learning to analyze data and optimize workflows. Verista's customers include companies in the healthcare, financial services, and manufacturing industries. The company was founded in 2017 and is headquartered in Palo Alto, California.
Learn more about Verista
Size
50 employees
Industry
Enterprise Technology
Founded
2017
* Ladders Estimates

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