Principal Computer Validation Engineer

Oversight of and participation in the development and execution of Computerized System Validation Life-Cycle documents / protocols, including but not limited to Validation Compliance Assessments, Validation Plans, Qualification Protocols, User Acceptance Tests, Change Controls, Periodic Validation Reviews, Audits, and Corrective Actions for audit findings for automated systems at the Marietta, R&D, Clinical Drug product site. Ensure both technical and procedural content of computerized system validation deliverables reflect current GSK Policy and procedures, government regulations, and industry practices. Coordination of validation activities with internal business partners / key stakeholders in a manner that satisfies procedural and operational requirements.

Supervision, management, and mentoring of less senior validation personnel with the objective of completing computerized systems validation-related tasks in a timely manner and within budget, while providing quality and effective deliverables.

Key Responsibilities:

• Provide leadership in establishing and maintaining the validated state of Direct Impact systems with an emphasis on computerized systems. This includes stand alone automation systems as well as those embedded in vendor provided equipment (e.g. PLC)
• Manage and deliver the computerized system validation tasks and deliverables associated with both capital and non-capital projects.
• Serve as the principal automation validation member / team validation lead on projects.
• Participate in the development of requirements and specifications related to computerized systems validation.
• Perform and/or manage the completion of Validation Maintenance Review Program, and Business Capital Validation across the organization.
• Provide direction to Validation Staff and contracted third party validation staff based on business project needs.
• Support the development of the overall validation life cycle strategies, programs, and policies related to computerized system validation.
• Support internal audits as a Validation SME regarding validation of computerized systems.
• Participate in validation harmonization efforts across the organization to optimize the benefits to the business.
• Participate in Quality Management System document revisions, endorsement and gap assessments related to the validation of computerized systems. Provide input to the QMS Steering team as required.
• Support experimental studies to identify methods and design-of-experiments for studies leading to the validation of computerized systems.
• Provide input to the GSK matrix team environment to deliver GMP compliant electronic tracking systems and the batch record system suitable for deployment.
• Lead and engage in cross departmental project teams including R&D Information Technology (IT) and 3rd parties in delivering new, GMP compliant, electronic system capability.

We are looking for professionals with these required skills to achieve our goals:

• Scientific or engineering BS degree supplemented with 5+ years of computerized systems validation experience.
• Technical knowledge of enterprise, laboratory, and manufacturing systems and equipment commonly used in a GMP Clinical Sterile Manufacturing facility.
• Experience as a project team-member for capital projects (or similar) and proficient with computers, integrated systems, and tools that support validation activities and project management.
• Experience to interact well with peers, subordinates, and senior personnel in multidisciplinary teams involving scientific, engineering, operational, and quality disciplines.
• Experience working on multiple projects; the ability to focus on the important/prioritized projects, and the flexibility to adapt to changing priorities.
• Knowledge of government regulations, current industry standards and practices, and quality principles relevant to computerized systems validation.

• Knowledgeable of current standards for computerized systems validation with regard to :
  • Software Testing
  • Hardware Testing
  • Data Integrity
  • Electronic Records and Signatures
• General understanding / experience with the following as it relates to validation of computerized systems:

• cGMPs for FDA, EMEA and elsewhere
• Quality Management Systems
• QbD; Lean Sigma
• ICH Guidelines
• GAMP
• 21 CFR Part 11 compliance
• Project Management Framework

If you have the following characteristics, it would be a plus:

• Kneat electronic validation solution program (practical experience)
• Data Integrity & ALCOA principles & regulations - EU and FDA cGMP
• Industrial Building Automation Systems e.g., BMS, DeltaV, SCADA, DCS, etc.
• Data Historization knowledge & understanding of relevant software and hardware
• Analytical Systems knowledge and data capture/transfer process understanding

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