6321 - Validation Engineer / CQV Engineer - Change Control & Deviations

DescriptionVerista’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 expertiseWe are seeking a CQV Engineer to support change control and deviation management activities. This role will play a critical part in maintaining compliance, supporting quality systems, and ensuring manufacturing changes are properly assessed, documented, and executed in a regulated cGMP environment.The ideal candidate will have hands-on experience in change management, deviation investigations, and CQV lifecycle support within pharmaceutical or medical device manufacturing.Validation Engineer / CQV Engineer Responsibilities:Change Control ManagementAuthor, review, and manage change controls impacting systems, equipment, and processesPerform impact assessments, including evaluation of product quality, validated state, and regulatory impactCollaborate with cross-functional teams (Engineering, Quality, Validation, Manufacturing) to ensure timely and compliant change implementationSupport execution of change control deliverables, including updates to validation documentation (IQ/OQ/PQ, protocols, reports)Deviation ManagementLead and support deviation investigations, including root cause analysis and corrective/preventive actions (CAPAs)Ensure deviations are thoroughly documented, investigated, and closed within required timelinesPartner with Quality teams to ensure compliance with internal procedures and regulatory expectationsCQV & Compliance SupportMaintain alignment with cGMP and Good Documentation Practices (GDP)Support validation impact assessments and execution activities related to changesReview and approve validation and technical documentation as requiredParticipate in audits and inspections, providing SME support for change control and deviation processesCross-Functional CollaborationInterface with Manufacturing, Quality Assurance, Automation, and Engineering teams Support continuous improvement initiatives related to quality systems and CQV processesCommunicate project status, risks, and issues to stakeholdersRequirements:Bachelor’s degree in Engineering, Life Sciences, or related field3+ years of experience in CQV, Validation, or Quality Engineering in a regulated industryStrong experience with:Change control systemsDeviation investigations and root cause analysiscGMP and GDP environmentsFamiliarity with device assembly/packaging operations is highly preferredExperience supporting validation lifecycle activities (IQ/OQ/PQ) is a plusStrong technical writing and documentation skillsExcellent communication and cross-functional collaboration abilitiesOnsite job requirement in Indianapolis, INFor 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.*Verista is an equal opportunity employer.National (US) Range: $59,951 USD - $102,623 USDBenefitsWhy Choose Verista?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 BereavementVerista collects and processes personal data in accordance with applicable data protection laws. If you are a California Job Applicant, see the privacy notice for further details.For more information about our company, please visit us at Verista.com