Senior CSV Validation Engineer

About the role

The incumbent is responsible for leading computerized systems validation projects. This includes qualification of GxP computerized systems for both laboratory and manufacturing based equipment as well as GMP software applications. Key deliverables are preparation of relevant documentation to meet regulatory requirements for new and existing products (Validation Plans, User Requirements Specifications (URS), Risk Assessments, IQ/OQ/PQ protocols and Traceability Matrices). Collaborate with cross functional teams, ensure compliance with regulatory requirements, and drive best-in-class validation practices that support our Quality Management System and operational excellence.

Essential Job Functions

• Lead Protocol generation, oversee execution, data analysis, report generation and approval of qualification activities for GMP software applications
• Review and approve qualification documentation on behalf of the validation function
• Evaluate, audit, and guide software validation activities to ensure compliance with FDA, ISO, Data Integrity guidance, and internal standards
• Serve as initiator and owner of validation related change controls and corrective and preventative actions
• Support investigations into protocol nonconformances and site deviations
• Support the execution and generation of formal risk assessments
• Enhance CSV validation programs
• Analyze validation data, identify gaps, and support investigations and corrective actions
• Represent CSV during audits and regulatory inspections

Special Work Requirements

• Fully onsite position
• Strong communication skills
• Familiarity with Microsoft Office, Excel, and Visio
• Ability to work well with diverse groups in a matrix-style, growing, safety focused organization
• Ability to manage multiple activities
• The ability to communicate with fellow project team members

Education/Certifications/Licenses

• A minimum of a Bachelor’s degree in Engineering, Computer Science or related discipline

On-the-Job Experience

• 7+ years of Computer System Validation experience

Knowledge, Skills and Experience

• In depth CSV experiences including as a Validation lead
• The ability to communicate with employees of all experience levels from Genezen and other contract firms
• The ability to report on project activity in a clear and concise manner
• The ability to communicate with fellow project team members
• Understanding of cGMP regulations
• Technical writing ability
• Familiarity with Microsoft Office
• The ability to work well with diverse groups in a matrix-style, growing, safety focused organization
• The ability to manage multiple activities with challenging timelines
• In depth knowledge of 21 CFR Part 11, EU GMP Annex 11 and GAMP5 computerized system

Genezen's Cures Value-Based Competencies

• Committed to Science
• Urgency in action for the patients
• Resilience & Grit in operations
• Solutions driven for our partners

Genezen's Benefits

• Paid vacation days, amount based on tenure
• Paid sick time
• 10 observed holidays + 2 floating holiday + 1 volunteer day
• 401(k) plan with company match up to 6% of salary, vested immediately
• Choice of several healthcare plans
• FSA and HSA programs
• Dental & vision care
• Employer-paid basic term life/personal accident insurance
• Voluntary disability, universal life/personal accident insurance
• Accidental Death & Dismemberment (AD&D) Insurance

Additional Details

• This position requires a criminal background check
• Genezen is an Equal Opportunity Employer
• Genezen participates in EVerify
• Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts