CSV Engineer

JobDiva, Inc.; Cambridge (MA); In loco; USD 100.000 - 140.000; Tempo pieno

Descrizione del lavoro

JobDiva, Inc. seeks a Computer Systems Validation Engineer to validate GxP computer systems, both on‑premises and cloud-based, ensuring compliance with industry standards. You will draft docs, perform risk assessments, and manage validation lifecycles.

You will lead CSV/CSA guidance, develop harmonized procedures, and generate lifecycle artifacts (URS, IQ/OQ/PQ, RTM) while assessing new systems for impact and balancing compliance with efficiency.

Competenze

• Bachelor's degree in Engineering, Computer Science or related discipline.
• 3–5+ years of CSV experience in an FDA regulated industry.
• Strong knowledge of cGMP and FDA 21 CFR Part 11 and EU Annex 11.
• Understanding of data integrity requirements and assessments.
• Experience qualifying on premises and cloud-based software systems.
• Ability to influence stakeholders on CSV, CSA and GxP compliance.
• Experience managing complex validation projects and timelines.
• Knowledge of quality systems such as change control and discrepancy investigations.
• Experience with IT qualification of network and infrastructure.
• Demonstrated written and verbal communication skills.

Mansioni

• Provide CSV and CSA compliance guidance to IT, system owners, and stakeholders.
• Lead development and adherence to CSV/CSA procedures with risk-based validation.
• Generate and execute lifecycle deliverables per GAMP 5 (URS, SRS, FRS, DDS, RTM, IQ/OQ/PQ).
• Assess proposed systems for GxP impact and define CSA validation strategy.
• Review vendor documentation and perform independent risk-based verification.
• Support change control, deviation resolution, CAPA and effectiveness checks.
• Manage decommissioning of retired systems.
• Ensure supplier controls and risk-based oversight of IT services.

Conoscenze

CSV compliance

Regulatory knowledge

Risk-based methodology

Documentation

Validation lifecycle

Vendor management

cGMP knowledge

FDA 21 CFR Part 11

Communication skills

Mentoring

Formazione

Bachelor's degree in Engineering/Computer Science or related discipline

Strumenti

LabWare LIMS

MasterControl

SAP

Blue Mountain

EMS

IT infrastructure

Descrizione del lavoro

Summary

The Computer Systems Validation Engineer will be responsible for ensuring GxP computerized systems, including both on premises and Cloud/Server based applications, are validated and controlled in compliance with industry standards and regulations. The CSV Engineer will be primarily responsible for validating manufacturing, laboratory, and enterprise computerized systems. Other responsibilities include drafting system documentation, conducting risk assessment, and providing validation lifecycle management.

Roles & Responsibilities

• Provide CSV and CSA-based compliance guidance to the IT function, system owners, and business stakeholders, applying a risk-based approach focused on patient safety, product quality, and data integrity.
• Lead the development, harmonization, implementation, and adherence to CSV and CSA procedures, ensuring validation effort is commensurate with system risk, intended use, and GxP impact.
• Generate/Revise/Execute system life cycle deliverables using a risk-based CSA methodology and GAMP 5 guidelines (including URS, SRS, FRS, DDS, RTM, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Risk Assessments and Final Validation Summary Report as applicable)
• Evaluate proposed new computerized systems and software to determine GxP impact, system criticality, and intended use, and define a CSA aligned validation strategy that balances compliance, efficiency, and business needs.
• Review and assess vendor supplied documentation and testing evidence, leveraging supplier activities where appropriate, and perform independent risk-based verification to ensure compliance with internal requirements and regulatory expectations.
• Support change control activities, deviation resolution, CAPA, and effectiveness checks for computer systems.
• Manage and execute decommissioning activities for retired or end of life systems.
• Ensure that suppliers of IT services and solutions are properly assessed to determine their level of compliance and ensure that appropriate controls are in place based on risk

Education & Experience

• Bachelor's degree in Engineering, Computer Science or related discipline.
• Must have 3-5+ years of CSV experience in an FDA regulated industry.
• Strong knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA 21 CFR Part 11and EU Annex 11 regulations and standards.
• Understanding of data integrity requirements and how to perform assessments.
• Knowledge and experience with qualifying on premises and externally hosted (SaaS, PaaS, IaaS) software systems.
• Ability to work with and influence people at all levels in matters related to CSV,CSA and GxP compliance.
• Demonstrated experience in successfully managing complex validation projects and maintaining validation requirements and timelines.
• Understanding of quality systems such as change control and discrepancy investigations.
• Experience working with IT for qualification of network and infrastructure.
• Demonstrated written and verbal communication skills.
• Proficient with Microsoft Office, particularly Word and Excel.
• High degree of initiative and self-motivation.
• Experience creating technical, written content.
• Ability to mentor team members and colleagues.
• Experience with systems like LabWare LIMS, MasterControl, SAP, Blue Mountain, Environmental Monitoring Systems (EMS), and IT infrastructure components.