Job DescriptionCSV Systems Engineer III in Hopkinton, MAThe CSV Systems Engineer will be responsible for supporting Quality Management Systems and Computer System Validation efforts. This role will provide guidance and expertise on various global and site CSV projects to ensure that quality teams have the necessary tools to provide quality metrics, measurements, and reports for internal audits and inspections.
Responsibilities- Lead and manage multiple site and global Computer System Validation (CSV) initiatives concurrently, ensuring computerized systems (standalone, interfaced/automated with Analytical equipment, interfaced/automated with manufacturing equipment) remain validated and compliant throughout their lifecycle.
- Develop, review, execute, and maintain risk-based CSV deliverables, including validation plans, requirements, risk assessments, qualification/validation protocols, traceability documentation, reports, periodic reviews, and system retirement documentation, as applicable.
- Serve as a CSV subject matter expert (SME), providing technical and compliance guidance on validation strategies, SOPs, templates, system configuration changes, and computerized system lifecycle controls.
- Own and support CSV-related change controls, deviations/quality events, CAPAs, system defects, and associated investigations. Provide risk-based guidance for issues that may affect system compliance, validated state, product quality, or GxP data integrity.
- Maintain oversight of applicable scientific applications and computerized systems, including system inventory, GxP classification, validation status, software/hardware configuration, periodic review status, and lifecycle documentation.
- Partner with IT, Laboratory Operations, system owners, and vendors to ensure appropriate controls for antivirus protection, backup processes, operating-system lifecycle management, security patching, and other infrastructure changes that may affect validated systems.
- Serve as the CSV SME during internal audits, client audits, and regulatory inspections. Support responses, remediation activities, and timely closure of CSV-related audit commitments and compliance gaps.
- Execute or coordinate periodic reviews and risk assessments to verify that GxP computerized systems remain fit for intended use, appropriately controlled, and maintained in a validated state.
- Collaborate closely with Quality, IT, Laboratory Operations, system owners, business users, vendors, and global CSV teams to assess computerized system requirements, validation impacts, changes, risks, and project status.
- Provide routine reporting on validation projects, system inventories, periodic reviews, CAPAs, change controls, quality events, SOP/template development, audit observations, and remediation activities. Identify opportunities to improve and standardize CSV processes.
Qualifications - Bachelor's degree in Computer Science, Information Technology, Engineering, Life Sciences, or a related technical/scientific discipline; or an equivalent combination of education and relevant experience.
- Minimum 6 - 8 years of progressive experience in Computer System Validation (CSV), computerized systems, Quality, or IT within a GMP-regulated pharmaceutical, biotechnology, or life-sciences environment.
- Demonstrated hands-on experience administering and supporting computerized systems, including activities such as user and security administration, system configuration, access management, software upgrades, backup/recovery, patching, troubleshooting, and coordination of vendor support, as applicable.
- Strong Hands-on experience validating software and computerized systems associated with GMP manufacturing equipment, laboratory instruments, and scientific applications, including standalone, networked, and integrated systems.
- Demonstrated experience executing risk-based CSV activities across the computerized system lifecycle, including requirements, risk assessments, qualification/validation protocols, configuration and functional testing, traceability, validation reporting, change control, periodic review, and system retirement, as applicable.
- Working knowledge of GxP computerized system and data integrity expectations, including applicable requirements and industry guidance such as 21 CFR Part 11, EU GMP Annex 11, GAMP 5, CSA framework, and data integrity principles.
Other Qualifications- Must pass a background check
- Must pass a drug screen
- May be required to pass Occupational Health Screening
Pay Range: $122,800-$145,300/yr.
Education, experience, location and tenure may be considered along with internal equity when job offers are extended.
We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.
All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address.
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