Principal Computer Validation Engineer

Role Summary

Principal Computer Validation Engineer responsible for oversight and execution of Computerized System Validation lifecycle documents and procedures at the Marietta R&D, Clinical Drug Product site, ensuring alignment with policy, regulations, and industry practices. Leads validation activities, mentors staff, and coordinates with internal partners to meet procedural and operational requirements.

Responsibilities

• Provide leadership in establishing and maintaining the validated state of Direct Impact systems with an emphasis on computerized systems, including stand-alone automation and vendor-provided equipment (e.g., PLC).
• Manage and deliver computerized system validation tasks and deliverables for both capital and non-capital projects.
• Serve as the principal automation validation member / team validation lead on projects.
• Develop requirements and specifications related to computerized systems validation.
• Perform and/or manage Validation Maintenance Review Program and Business Capital Validation across the organization.
• Provide direction to Validation Staff and contracted third-party validation staff based on project needs.
• Support development of overall validation life cycle strategies, programs, and policies for computerized system validation.
• Support internal audits as a Validation SME regarding validation of computerized systems.
• Participate in validation harmonization efforts to optimize business benefits.
• Contribute to Quality Management System document revisions, endorsements, and gap assessments related to validation; provide input to the QMS Steering team as required.
• Support experimental studies and design-of-experiments for validation of computerized systems.
• Provide input to deliver GMP compliant electronic tracking systems and batch record systems.
• Lead and engage cross-departmental project teams with R&D IT and third parties to deliver new, GMP compliant electronic system capability.

Qualifications

• Required: Scientific or engineering BS degree with 5+ years of computerized systems validation experience.
• Required: Technical knowledge of enterprise, laboratory, and manufacturing systems and equipment in a GMP Clinical Sterile Manufacturing facility.
• Required: Experience as a project team member for capital projects and proficiency with computers, integrated systems, and tools that support validation and project management.
• Required: Ability to interact effectively with peers, subordinates, and senior personnel in multidisciplinary teams.
• Required: Experience managing multiple projects with ability to adapt to changing priorities.
• Required: Knowledge of government regulations, industry standards, and quality principles related to computerized systems validation.

Skills

• Knowledge of standards for computerized systems validation in software testing, hardware testing, data integrity, and electronic records/signatures.
• Understanding of cGMPs (FDA, EMEA), Quality Management Systems, QbD/Lean/Sigma, ICH Guidelines, GAMP, 21 CFR Part 11, and Project Management Framework.

Education

• BS in a scientific or engineering discipline; advanced degree not specified.