Validation Engineer

Veeva LIMS Sme Consultant / Senior Validation EngineerIndianapolis, INVerista'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 colleaguesWe commit to client success at every turnWe have the courage to do the right thingWe 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 expertiseSenior Validation Engineer Responsibilities:Lead/Support a Veeva LIMS implementation and the validation activities throughout the system lifecycle, from requirements and design through testing, deployment, and validation closeoutDevelop and/or review validation deliverables, including URS, risk assessments, validation plans, test scripts, traceability matrices, validation summary reports, and SOPsPartner with Quality, Laboratory, IT, Business Process Owners, and system stakeholders to define requirements and ensure the LIMS meets business and regulatory needsSupport Veeva LIMS configuration, functional testing, integration testing, user acceptance testing, and defect resolutionApply risk-based CSV/CSA principles and applicable GxP requirements to ensure the validated state of the system is maintainedSupport data migration, interfaces, integrations, and related systems as part of the LIMS implementationParticipate in system change control, deviations, CAPAs, periodic reviews, and other lifecycle activities following implementationProvide technical and validation expertise during implementation meetings, workshops, testing activities, and issue resolutionEnsure validation activities comply with applicable regulatory expectations, company procedures, and industry practices such as GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principlesSupport inspection and audit readiness by ensuring complete, accurate, and traceable validation documentationJob Requirements:Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline5+ years of experience in computerized system validation, quality, or validation engineering within pharmaceutical, biotechnology, or other GxP-regulated environmentsDemonstrated experience with Veeva LIMS implementation, validation, or lifecycle managementStrong understanding of CSV/CSA methodologies, GxP requirements, risk-based validation, and data integrityExperience developing and executing validation/testing documentation, including requirements, risk assessments, test protocols/scripts, traceability, and validation reportsStrong understanding of 21 CFR Part 11, EU Annex 11, GAMP 5, and applicable data integrity principlesStrong project management, organizational, communication, and problem-solving skillsNational (US) Range: $85,470 - $136,225 USDBenefits:High growth potential and fast-paced organization with a people-focused cultureCompetitive pay plus performance-based incentive programsCompany-paid Life, Short-Term, and Long-Term Disability Insurance.Medical, Dental & Vision insurancesFSA, DCARE, Commuter BenefitsSupplemental Life, Hospital, Critical Illness and Legal InsuranceHealth Savings Account401(k) Retirement Plan (Employer Matching benefit)Paid Time Off (Rollover Option) and HolidaysAs Needed Sick TimeTuition ReimbursementTeam Social Activities (We have fun!)Employee RecognitionEmployee Referral ProgramPaid Parental Leave and Bereavement