Job Description Target Pay Rate: 90-100k **salary will be commensurate with experience Job Description:The Validation Associate II is a key member of the Computer Systems Validation team within the Technical Services organization. The Validation Associate II must have a working knowledge of the overall requirements dictated by worldwide regulatory agencies with respect to computer systems validation. This position works directly with the Information Technology department and other functional areas and is considered the lead validation resource. The Validation Associate II understands industry best practices and maintains a state of audit readiness always. This position reports to the Manager, Computer Systems Validation.
What you'll be doing: Validation document author/reviewer – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templatesTechnical writing proficiency – VP, URS, FS/DS, TM, IQ, OQ, PQ using established templates.Entitlement Reviews – Coordinates user access reviews for recertification and authorizationLocal Change Control ownerCSV periodic reviews – to maintain the validated state, the Associate will perform periodic reviews of validation packages per established proceduresValidation lead GAMP Category 1 - 4Client audits – The Associate will participate in client audits, responding verbally to auditor's questions.Global Change Control task ownerSystem assessments – Quality, Regulatory, Risk, GapCAPA ownerNCR/SNCR investigatorValidation Lead for implementation of major and minor software applications or modules for Good Manufacturing Practices (GMP) use.Completes detailed risk assessment and 21 CFR part 11 Gap analysisMaintains departmental compliance with regulations and corporate proceduresCoordinates computer systems implementation activities with Vendors and other non-BPS resourcesCreates/Reviews validation documentation, templates, procedures, and all documentation generated during a computer systems validation projectParticipates in Internal/Client/Corporate AuditsRepresents validation department as validation expert in cross-functional work teamsAdvocates and understands best practices for system validations and processesArticulates complex systems and communicates to technical and nontechnical managementThat you'll bring:B.S./B.A. in a related field (or equivalent experience)Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: ERP, EDMS, QMS, etc.)Experience with Microsoft ProjectMinimum 3 years' experience of working within a regulated environment (worldwide regulatory agencies), particularly in computer systems validation or other validation disciplineMinimum of 2 years to gain the experience needed to master Validation Associate II responsibilitiesPhysical / Safety RequirementsDuties may require overtime work, including nights and weekendsUse of hands and fingers to manipulate office equipment is requiredPosition requires sitting for long hours, but may involve walking or standing for periods of time
