Job Title: Validation EngineerJob DescriptionWe are seeking a dedicated Validation Engineer to provide ongoing maintenance and support of quality applications. This role involves user access maintenance, periodic system reviews, troubleshooting, and incident management. The successful candidate will also communicate with vendors for unresolved issues and assess software upgrades and enhancements.ResponsibilitiesMaintain user access for quality applications.Conduct periodic system reviews, including user access, audit trail, and backup reviews.Troubleshoot and manage incidents related to quality applications.Communicate with vendors to resolve issues that cannot be addressed internally.Assess and implement vendor software upgrades and enhancements.Initiate Change Controls.Draft Validation Plans.Develop User Requirements.Perform System Assessments.Complete Data Integrity Checklists.Review vendor protocols.Document Configuration Specifications.Execute validation protocols as needed.Draft Validation Summary Reports.Essential SkillsExpertise in Computer System Validation.Experience in GMP environment, particularly in a QC Lab.Proficiency in Windows system configuration, including system backup.Knowledge of validation protocols and validation testing.Understanding of pharmaceutical validation, including IQ and OQ.Additional Skills & QualificationsExperience with ERP implementations.Ability to support IS/Tech Ops groups in a high-profile project.Strong communication skills for vendor interactions.Work EnvironmentThis role requires working in a fast-paced environment, with 100% onsite work. The candidate should be comfortable working with various workstreams to support a global organization's high-profile project.About ActalentActalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.Diversity, Equity & InclusionAt Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:Hiring diverse talentMaintaining an inclusive environment through persistent self-reflectionBuilding a culture of care, engagement, and recognition with clear outcomesEnsuring growth opportunities for our peopleThe company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email (% ) for other accommodation options.
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