Validation SpecialistThis role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area. The Validation Specialist will support validation leads to ensure the required deliverables and testing are complete according to the Client CSV SOP. Effective communication is key across a multi-functional team consisting of Business, IT, and Quality personnel.
Experience with current digital validation tools is required, and the use of AI as an accelerator is a plus. A solid CSV background and a strong work ethic in an aggressive project setting will be key to success in this role.Required Skills & QualificationsBachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific or technical discipline8–10 years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments5 years of experience in Data Integrity/ALCOA principles5 years of experience with CSA principles5 years of experience with technical writingWorking knowledge of GMP, GLP, and GAMP 5 principlesStrong understanding of FDA regulations, ICH guidelines, and EU Annex 11 (as applicable)Experience developing, executing, and reviewing validation protocols and reports, risk assessments (FMEA, impact assessments), SOPs, deviation investigations, and CAPAsAbility to support regulatory inspections and audits (FDA, EMA, internal, or client audits)Strong technical writing skills with attention to detail and data integrityProficiency with common pharmaceutical documentation systems and tools (e.g., EDMS, change control systems)Excellent organizational, communication, and cross-functional collaboration skillsPrior work experience at client or in client's IndustryApplicants must be able to work directly for Artech on W2Preferred Skills & QualificationsCross-functional experience in one or more regulated areas (i.e., Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT, etc.)Ability to provide innovative ideas to improve quality and compliance that create value, including seeking new information and external insightsFamiliarity with using AI as an accelerator for the creation and review of documents and testingDay-to-Day ResponsibilitiesSupport creation, review, and approval of all CSV deliverables for custom in-house solutionsMaintain close communication with stakeholders and team members to keep apprised of CSV needs, interpretation of requirements, impacts on compliance of an application, project status, and other relevant issuesAbility to create documents to an existing document standardObtain and respond to review by Business, IT, and Quality stakeholdersFollow SOPs and industry best practicesAdvanced knowledge of complete MS Office suite and Visio. Firm understanding of technology platforms as needed for the projectExperience with electronic document management systems (e.g., Qumas, SharePoint, etc.); application development and lifecycle management (e.g., ALM, JIRA, etc.); and IT service management systems (e.g., ServiceNow)Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team membersCompany Benefits & CultureCommitment to QualityStrong critical thinking to analyze complex situations and discern critical issuesAble to work effectively with a highly-matrixed and multi-cultural workforce and build strong relationships by being transparent, reliable, and delivering on commitmentsExcellent team player attitudeAbility to manage competing priorities