CSV Systems Engineer III

Curia Aalborg ApS; Hopkinton (MA); On-site; USD 123,000 - 145,000; Full time

Benefits offered by this job

Generous benefits

Paid time off

Career advancement

Education reimbursement

401K with matching

Learning platform

Job summary

Curia is seeking a CSV Systems Engineer III in Hopkinton, MA to lead sites and global CSV programs, ensuring validated, compliant computerized systems. The role requires extensive CSV lifecycle expertise, regulatory knowledge, and collaboration with IT, QA, and vendors.

The engineer will develop risk-based validation deliverables, support audits, and drive continuous improvement across CSV processes in a GMP environment.

Qualifications

• Bachelor's degree or equivalent in a technical/scientific discipline.
• 6–8 years experience in CSV, Quality, or IT in GMP environments.
• Hands-on experience with system administration, security, backup, patching.
• Experience validating software and systems in GMP manufacturing and labs.
• Knowledge of 21 CFR Part 11, EU GMP Annex 11, GAMP 5.

Responsibilities

• Lead and manage site and global CSV initiatives while keeping systems validated.
• Develop and maintain CSV deliverables: plans, protocols, reports.
• Act as CSV SME for guidance on validation strategies and SOPs.
• Own change controls, deviations, CAPAs and investigations.
• Collaborate with IT, QA, and vendors to ensure controls and lifecycle management.
• Report on validation projects and identify process improvements.

Skills

CSV knowledge

GxP/data integrity

System administration

Regulatory compliance

Education

Bachelor's degree in relevant field

Job description

CSV Systems Engineer III in Hopkinton, MA

Build your future at Curia, where our work has the power to save lives.

Job Description

CSV Systems Engineer III in Hopkinton, MA

Build your future at Curia, where our work has the power to save lives.

The 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.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

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.

Curia is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Curia is an E-Verify employer.