CSV Systems Engineer II

Curia • Albany, NY

4d

About The Position

The CSV Systems Engineer II/III, based in Albany, NY, supports Quality Management Systems and Computer System Validation (CSV) efforts. The role provides guidance and expertise on global and site CSV projects to help quality teams produce the metrics, measurements, and reports needed for internal audits and inspections. The level will depend on experience.

The position manages CSV projects, creates and reviews validation deliverables, supports quality events and audit readiness, maintains inventories of scientific applications and computer systems, and assists with IT compliance activities. It also provides routine reporting on project status, inventory, procedures, templates, corrective actions, quality events, change records, and audit observations.

Requirements

• Bachelor's degree in Information Technology or a related field.
• Minimum of 3 years of experience in quality and computer systems validation and/or information technology.

Nice To Haves

• Experience in the pharmaceutical industry.

Responsibilities

• Manage multiple site and global Computer Systems Validation projects.
• Communicate with stakeholders and team members about computerized system needs, validation impacts and status, and related issues.
• Create CSV deliverables for CSV projects.
• Provide expertise in SOP generation and CSV processes.
• Own general configuration modifications to CSV systems in accordance with CSV compliance standards.
• Provide expertise in creating CSV execution templates.
• Perform CSV risk assessments.
• Own CSV change records, CAPAs, and quality events for CSV projects.
• Act as a CSV reviewer for project defects and deviations.
• Support site and global CSV actions arising from audits.
• Participate in site audits and inspections as a CSV subject matter expert.
• Provide guidance and resolution for quality issues affecting data or system integrity.
• Gather and maintain inventories of scientific applications and computer systems at Curia sites, including GMP and non-GMP systems.
• Inform the Service Engineer I of changes in software and hardware status.
• Support the Lab Ops team in ensuring computer systems have up-to-date antivirus software and backup software installed.
• Support the Lab Ops team in updating computer systems running outdated operating systems.
• Perform monthly patching auditing risk assessments with the Lead CSV Compliance Analyst.
• Support periodic internal audits and inspection readiness.
• Execute periodic reviews and data collection.
• Provide routine project status reports, software and hardware inventory updates, and progress updates on SOPs and templates.
• Provide CAPA, quality event, and change record updates to the compliance team.
• Provide routine audit observations and remediation updates.

Benefits

• Generous benefit options, eligible from the first day of employment.
• Paid training.
• Vacation and holidays, with vacation accrual beginning on the first day of employment.
• Career advancement opportunities.
• Education reimbursement.
• 401(k) program with matching contributions.
• Learning platform.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level