6495 - Senior CQV Engineer / Senior Validation Engineer

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.

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

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

Benefits

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