Senior Software Validation Engineer

Jobot - Senior Software Validation Engineer

Passion for the Pharma/ Medical Device/ or Biotech industries? Take a closer look!This Jobot Job is hosted by: Jenner WigginsAre you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary: $100,000 - $140,000 per yearA bit about us:We are a Privately owned immunotherapy company developing next-generation therapies that drive immunogenic mechanisms for defeating cancer and infectious diseases.Why join us?

• Competitive Base Salary!
• Extremely Competitive Equity Package!
• Flexible Work Schedules!
• Accelerated Career Growth!
• Company Matched 401(k)!

Job DetailsSUMMARY:As the Senior Validation Engineer you will be responsible for compliance oversight of enterprise CSV projects as part of the IT team. This role is hands-on, highly cross-functional, and works closely with various business stakeholders to ensure GxP compliance. Supports validation of all Manufacturing, R&D, and Quality systems. Coordinates and/or supports delivery of compliance deliverables such as System Inventory, Quality Impact Assessments, Data Integrity Assessment, Risk Assessments, Gap Analysis, System Remediation, System Change Control and CAPA investigations/resolutions.MUST HAVES:

• 21 CFR Part 11
• Understanding of Validation Lifecycle

-GAMP5DUTIES & RESPONSIBILITIES:

• Oversee the execution of qualification/validation activities of new software implementations and maintenance of existing systems.
• Author, review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports).
• Perform risk assessments with functional teams to assess system risks and develop mitigation plans
• Update and/or create computer system related policies, procedures, templates, forms, etc.
• Provide input to GxP assessments for 21 CFR Part 11 requirements
• Oversee the execution of qualification/validation activities new software implementations and maintenance of existing systems.
• Author, review and approve qualification/validation documentation (specifications, protocols, risk assessments, reports).
• Perform risk assessments with functional teams to assess system risks and develop mitigation plans
• Update and/or create computer system related policies, procedures, templates, forms, etc.
• Provide input to GxP assessments for 21 CFR Part 11 requirements
• Review and approve computer system change controls, discrepancies, CAPAs
• Review and provide feed to vendor validation documentations (validation plans, executed protocols, risk assessments, etc.)
• Works closely with the QA function to provide expertise in CSV compliance, manage identified issues, and support continuous improvement.
• Support inspection readiness programs and/or directly support regulatory agency inspections. Assist in the coordination of response to any findings as applicable.
• Develop and evaluate quality processes and system standards to ensure compliance with applicable procedures, industry standards and global regulations.

EDUCATION & EXPERIENCE:

• Bachelors Degree
• 5+ years of experience working in biotech/pharmaceutical industry in Quality compliance or Computer System Validation role.
• Strong knowledge in CFR 21 Part 11, GAMP5, electronic record/electronic signature, and data integrity requirements, standards and guidelines.
• Strong background and understanding of FDA regulations.
• Knowledge of Good Clinical practice (GCP), Good pharmacovigilance Practice (GVP), Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and Good Laboratory Practices (GLP).
• Experience in authoring/reviewing/approving validation documentation.
• Working knowledge of software development lifecycle (SDLC).
• Experience supporting enterprise software deployments, ERP, DMS, QMS, etc.

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.