Senior CSV & Data Integrity Engineer (GxP Systems)

Genezen; Lexington (MA); On-site; USD 115,000 - 140,000; Full time

Benefits offered by this job

Paid vacation days

401(k) plan with company match up to 6

Healthcare plans

FSA and HSA programs

Employer-paid life/personal accident

Voluntary disability

Job summary

Genezen is seeking a Sr. Validation CSV expert to lead computerized systems validation projects supporting both laboratory and manufacturing environments.

You will prepare Validation Plans, URS, IQ/OQ/PQ protocols, and Traceability Matrices to meet regulatory requirements for new and existing products, while working with cross-functional teams to uphold data integrity. You will ensure compliance with FDA, EU GMP, ICH guidelines and data integrity standards, and drive best-in-class practices

Qualifications

• Bachelor's degree in Engineering, Computer Science or related discipline.
• 7+ years of Computer System Validation experience.
• Strong understanding of GxP computerized systems and validation principles.
• Experience leading validation projects for Enterprise, Laboratory, Manufacturing, and Quality Systems.
• Experience with risk-based CSV strategies.
• Experience with audit trails and data integrity assessments.

Responsibilities

• Lead risk-based validation strategies for GxP computerized systems across the lifecycle.
• Review and approve qualification documentation on behalf of the validation function.
• Ensure compliance with FDA, EU, ISO, and data integrity guidelines.
• Assess impact of events on validated state and data reliability.
• Lead validation execution with properly documented testing.
• Support QA events involving CSV, CAPAs, deviations, and change controls.
• Develop and improve CSV procedures, templates, and guidance.
• Support risk-based Data Integrity Assessments and audit trails.

Skills

CSV leadership

GxP systems

Regulatory knowledge

Risk-based validation

Documentation writing

Data integrity

Audit trail knowledge

Project management

cGMP understanding

Microsoft Office

Education

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

Tools

Adobe Acrobat

Visio

MS Office

Job description

Genezen is seeking a Sr. Validation CSV expert to lead computerized systems validation projects supporting both laboratory and manufacturing environments.

You will prepare Validation Plans, URS, IQ/OQ/PQ protocols, and Traceability Matrices to meet regulatory requirements for new and existing products, while working with cross-functional teams to uphold data integrity. You will ensure compliance with FDA, EU GMP, ICH guidelines and data integrity standards, and drive best-in-class practices