CSV Systems Engineer II

Curia • Albany, NY

4d

About The Position

The CSV Systems Engineer supports Quality Management Systems and Computer System Validation (CSV) efforts. The role provides guidance and expertise on global and site CSV projects so quality teams have the tools needed to provide quality metrics, measurements, and reports for internal audits and inspections. The position is in Albany, New York, and the level will depend on experience.

The role also supports computerized-system compliance, inventory management, periodic audit readiness, and quality reporting across Curia sites, including GMP and non-GMP environments.

Requirements

• Bachelor’s degree in Information Technology or a related field.
• At least 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 CSV projects concurrently.
• Communicate with stakeholders and team members about computerized-system needs, computer validation impacts, project validation 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 the CSV reviewer for defects and deviations within projects.
• 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 inventory and maintain scientific applications and computer systems across Curia sites, in both GMP and non-GMP environments.
• Inform the Service Engineer I of changes in software and hardware status.
• Support the Lab Ops team in maintaining up-to-date antivirus software and backup software installations on computer systems.
• Support the Lab Ops team in updating computer systems running outdated operating systems.
• Perform monthly patching audit risk assessments with the Lead CSV Compliance Analyst.
• Execute periodic reviews and data collection for internal audit and inspection readiness.
• Provide routine project status reports, software and hardware inventory updates, SOP and template progress updates, CAPA/QE/CR updates to the compliance team, and audit observation and remediation updates.

Benefits

• Generous benefit options, available from the first day of employment.
• Paid training, vacation, and holidays; vacation accrual begins 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