6500 - Lead CQV Engineer / Lead Validation Engineer

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Senior Validation Engineer Responsibilities:

• Lead and execute validation and qualification activities for facilities, utilities, manufacturing equipment, laboratory systems, and/or computerized systems within GxP-regulated environments.
• Author, review, and approve validation deliverables, including URS, validation plans, risk assessments, protocols, test scripts, IQ/OQ/PQ documentation, deviations, traceability matrices, and validation/qualification summary reports.
• Plan, coordinate, and perform hands-on validation execution, including protocol execution, field verification, system walkdowns, functional testing, punch-list management, and acceptance testing.
• Serve as the validation technical lead for assigned projects, providing direction on validation strategy, scope, execution approach, documentation, and issue resolution.
• Coordinate with Engineering, Quality, Operations, Automation, IT, vendors, and other stakeholders to ensure validation activities, project milestones, and deliverables are completed on schedule.
• Review engineering and vendor documentation, including drawings, specifications, manuals, FAT/SAT documentation, and commissioning records, to establish validation requirements and execution strategies.
• Lead the identification, investigation, and resolution of deviations, discrepancies, change controls, and validation-related issues.
• Ensure validation documentation and execution activities comply with cGMP, GAMP 5, ASTM E2500, data integrity principles, Good Documentation Practices, and applicable regulatory requirements.
• Track validation deliverables, project schedules, risks, action items, and dependencies; proactively communicate status and escalate issues that may impact project timelines or compliance.
• Provide technical leadership, coaching, and mentoring to validation engineers and less experienced team members.
• Support development and continuous improvement of validation procedures, templates, standards, and best practices.
• Maintain strong working relationships with project stakeholders and provide clear communication regarding validation strategy, progress, risks, and execution status.

Job Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or a related technical discipline.
• 7+ years of validation/CQV experience within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industries.
• Demonstrated hands-on experience with both authoring and execution of validation and qualification deliverables.
• Strong experience developing and executing IQ/OQ/PQ protocols, validation test scripts, commissioning documentation, and validation/qualification reports.
• Experience leading validation activities across one or more of the following: manufacturing equipment, process equipment, facilities, utilities, laboratory systems, automation, or computerized systems.
• Strong understanding of cGMP requirements, validation lifecycle principles, and risk-based validation approaches.
• Experience managing deviations, change controls, punch lists, action items, and resolution of validation issues.
• Demonstrated ability to independently manage multiple validation activities and deliverables while meeting project timelines.
• Project Lead or Project Management experience, including responsibility for coordinating project teams, schedules, deliverables, resources, risks, and stakeholder communication.
• Experience serving as a Validation Lead or CQV Lead on pharmaceutical or biotechnology capital projects.
• Experience managing validation workstreams from planning and requirements development through execution and final closeout.
• Strong knowledge of GAMP 5, ASTM E2500, risk-based qualification, data integrity/ALCOA+, and applicable FDA/EMA regulatory expectations.
• Experience coordinating and managing third-party vendors, contractors, and cross-functional project teams.
• Experience with project scheduling and tracking tools such as Microsoft Project, Smartsheet, Jira, or similar platforms.
• This role is hybrid - on-site presence between Wichita, KS and Boston, MA may be required.

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

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