Job Description

• Perform requalification of existing computer systems and support Periodic System Reviews to maintain a validated state.
• Oversee system development processes (build, test, deploy, monitor) to ensure compliance is maintained through every release, update, or iteration.
• Act as the Quality Lead for project teams, guiding the implementation of validation, security, and project management deliverables at appropriate stages of the system lifecycle.
• Provide expert guidance to project teams on compliance and security control requirements to ensure data integrity and system reliability are integrated by design.
• Review and approve system lifecycle documentation generated by project teams to ensure alignment with local SOPs and global regulatory expectations.
• Lead or contribute significantly to internal and external audits, including Health Authority inspections (FDA/EMA), and support the execution of corrective action plans.
• Support evaluation of existing legacy systems for technical integration and tool management.
• Advise on the implementation of compliance and security controls for both new and existing systems.

Senior Computer System Validation Consultant Qualifications:

• 8+ years of experience in the Life Sciences industry (Consulting or Industry) with a focus on Computer System Validation and Quality Compliance.
• Bachelor's degree in Life Sciences, Engineering, Computer Science, or related discipline (an equivalent combination of education and experience may be considered).
• Expert understanding of: FDA 21 CFR Part 11, 210/211, and 820, EU EudraLex Volume 4 (Annex 11 and Chapter 4), GAMP 5 and risk-based validation approaches, ALCOA+ principles and data integrity frameworks
• Strong IT/technical background with the ability to understand the complexities of networked programs and infrastructure.
• Familiarity with laboratory, manufacturing, and quality management systems for GMP operations, including: Electronic Document Management Systems (EDMS), Learning Management Systems (LMS), Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES)
• Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
• Experience developing training materials and delivering training to employees on CSV topics.
• Ability to lift up to 20 pounds as needed.

Shift:

• Standard hours 8am to 5pm - some flexibility to work earlier/late as needed.

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