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CSV Engineer (Analyst II)

Cambridge, MA, US • Posted 10 hours ago • Updated 10 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Cloud Computing
Technical Drafting
System Documentation
Lifecycle Management
GAMP
URS
Software Requirements Specification
FRS
RTM
Acceptance Testing
IQ
OQ
PQ
Risk Assessment
Reporting
Documentation
Testing
Corrective And Preventive Action
IT Service Management
Auditing
Computer Science
Manufacturing
Good Manufacturing Practice
Data Integrity
SaaS
PaaS
IaaS
Computerized System Validation
GxP
Regulatory Compliance
Management
Quality Management
Change Control
Network
Communication
Microsoft Office
Microsoft Excel
Motivation
Mentorship
LIMS
Master Control
SAP
EMS
Element Management System
IT Infrastructure

Cloud Computing
Technical Drafting
System Documentation
Lifecycle Management
GAMP
URS
Software Requirements Specification
FRS
RTM
Acceptance Testing
IQ
OQ
PQ
Risk Assessment
Reporting
Documentation
Testing
Corrective And Preventive Action
IT Service Management
Auditing
Computer Science
Manufacturing
Good Manufacturing Practice
Data Integrity
SaaS
PaaS
IaaS
Computerized System Validation
GxP
Regulatory Compliance
Management
Quality Management
Change Control
Network
Communication
Microsoft Office
Microsoft Excel
Motivation
Mentorship
LIMS
Master Control
SAP
EMS
Element Management System
IT Infrastructure

Summary

About the job:

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 And 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.
Participate in project teams executing various validation projects and communicate project plans, status updates and progress against milestones to project team members.
Maintain up to date knowledge of evolving regulatory requirements regarding computer systems and act as an information resource for the team and business stakeholders.
Support internal and external audits and regulatory inspections.
Perform other validation engineering duties as assigned.

Qualification:

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.

Preferred Qualifications:

Experience with systems like LabWare LIMS, MasterControl, SAP, Blue Mountain, Environmental Monitoring Systems (EMS), and IT infrastructure components.

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: 3de9129069337c8aba23f2246cf7a135
Posted 10 hours ago

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