Computer Systems Validation Engineer

Are You Ready?CAI is a professional services company established in 1996 that has grown to more than 700 people worldwide. We provide commissioning, qualification, validation, startup, project management, and other consulting services associated with operational readiness to FDA-regulated and other mission-critical industries.Our approach is simple—we put the client's interests first, we don't stop until it's right, and we do whatever it takes to get there.Our Foundational Principles:We act with integrityWe serve each otherWe serve societyWe work for our futureWe work diligently to accomplish team goals and live our core values:Team Before SelfRespect for OthersCan-Do AttitudeThis position could report to Rockville, MD or Frederick, MDKey ResponsibilitiesDocumentation & ComplianceAuthor GxP computer validation documentation (e.g., URS, FRS, RTM, summary reports)Generate and execute test protocols and scriptsEnsure adherence to 21 CFR Part 11 and data integrity principlesReview and contribute to validation plans and risk assessmentsSystem & Industry ExpertiseSupport CSV activities across various platforms including MES, DCS, SCADA, and batch systemsEngage with major systems and platforms such as Rockwell PharmaSuite, Rockwell Automation platforms, Emerson DeltaV, DeltaV Batch, Emerson Syncade, PI, GE, ABB, Siemens, Honeywell, PAS-X, FactoryTalk, FactoryLogix, PLM, Simatic, iFix, WonderwareApply knowledge of GAMP and compliance expectations (21 CFR Parts 210, 211, 11)Utilize familiarity with S88/S95 batch control standardsApply working knowledge of recipe authoring, batch recipe development, and S88-based recipe structures across systems such as DeltaV and RockwellClient Support & Technical ExecutionSupport client engagements with strong customer-service orientationPerform system assessments and remediation related to data integrityCollaborate with client teams to ensure validation compliance and deliveryQualifications and ExperienceBachelor's degree (BS/BA) in Computer Science, Engineering, or related field; equivalent experience may be acceptedMinimum of 3+ years of experience in computer systems validationExperience in biotech or pharmaceutical environments preferred over medical deviceIn-depth understanding of GAMP guidelines and FDA regulations (21 CFR 11, 210, 211)Familiarity with S88/S95 batch control standardsExperience with Rockwell platforms, DeltaV systems, and recipe authoring in batch environments strongly preferredExperience with multiple automation and manufacturing execution systems is highly desirableData integrity assessment/remediation experience is a plusOther RequirementsExcellent oral and written communication skills in EnglishAbility to travel domestically and internationally as requiredWillingness to work paid overtime when neededMust be authorized to work in the U.S. without current or future sponsorshipCritical CompetenciesInfluence StrategyPursues opportunities based on organizational fit and strategyIdentifies high-impact, innovative solutionsSatisfy the CustomerAnticipates and meets client needsDelivers high-quality solutions and maintains satisfactionPlan for SuccessAligns business goals with execution plansAllocates resources and builds risk mitigation strategiesPursue ExecutionPrioritizes effectively and ensures accountabilityProactively addresses challengesTailor CommunicationCommunicates clearly and professionallyAdapts style for technical and non-technical audiencesBuild PartnershipsBuilds cross-functional networksPromotes collaboration and stakeholder engagementInfluence OthersGains support through sound reasoningPromotes innovation and valueDevelop Self and OthersDemonstrates integrity and commitment to growthBuilds effective relationships internally and externally$75,000 - $106,000 a year Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment. CAI Benefits: Comprehensive Health Insurance coverage, 24 days of Paid Time Off, Company paid Life Insurance, Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all – our employees, our customers, and the broader society.This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).