Computer System Validation Engineer

Validation & Engineering Group Inc V&EG a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas Laboratory Compliance Computer Engineering Project Management Validation and other services We are seeking a Computer System Validation Engineer to execute periodic reviews for approximately 42 computerized systems supporting QC and QA operations The position will evaluate system lifecycle status data integrity changes incidents security controls validation documentation and continued fitness for intended use Computer System Validation EngineerKey Responsibilities Plan and execute computerized system periodic reviews according to approved schedules and procedures Review system validation and lifecycle documentation including Intended use and current system configuration Validation plans requirements specifications testing and reports Change controls incidents deviations CAPAs and problem records User access security roles and periodic access reviews Audit trails and data integrity controls Backup restoration archival and business continuity controls Software upgrades patches interfaces and infrastructure changes Vendor support and system obsolescence status Open validation actions and previous periodic review commitments Assess continued compliance with applicable cGMP data integrity and electronic record requirements Document validated state conclusions risks recommendations and required remediation Author and route periodic review reports validation assessments and supporting documents Support deviations CAPAs change controls and investigations involving computerized systems Collaborate with system owners Quality IT Automation laboratory personnel and validation SMEs Provide computerized system documentation and SME support during audits and inspections Maintain the computerized system review schedule trackers metrics and status reports Qualifications Bachelors degree in Engineering Computer Science Information Systems Life Sciences or a related discipline Five or more years of computerized system validation experience in pharmaceutical or biotechnology operations Strong knowledge of risk based CSV data integrity ALCOA principles 21 CFR Part 11 and applicable GAMP practices Experience conducting computerized system periodic reviews Experience with laboratory or quality platforms such as LIMS Maximo TrackWise PI Historian RIM QBMS or comparable systems Experience preparing audit ready documentation in Kneat CDOCs or equivalent platforms At Validation & Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you Validation & Engineering Group is an equal opportunity employer All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status