Investigator - Validation Project Manager

Basic qualifications:

  • Possesses a scientific BS degree supplemented with at least 5 years experience in a GMP environment developing technical knowledge of enterprise, laboratory, manufacturing systems and equipment commonly used for biopharmaceutical products.
  • Experience as a project team-member for capital projects and proficient with computers, integrated systems, and tools that support validation activities and project management.
  • Working knowledge of government regulations, current industry standards and practices, and quality principles relevant to validation.

Preferred qualifications:

  • Able to interact well with peers, subordinates, and senior personnel in multidisciplinary teams
  • involving scientific, engineering, and operational disciplines.
  • Demonstrated ability to work on multiple projects, the ability to focus on the important projects, and the flexibility to adapt to changing priorities.
  • Working knowledge of government regulations, current industry standards and practices, and quality principles relevant to validation.
  • An engineering degree is strongly preferred, or equivalent life science experience with equipment and systems use in a GMP environment.

Details:

  • Leadership in establishing and maintaining the validated state of Direct Impact systems and equipment, with an emphasis on enterprise systems, software applications, and computerized analytical systems.
  • Management of the validation tasks, deliverables, budgets, schedules, and resources associated with capital projects that involve installation of new Direct Impact systems and equipment, with an emphasis on enterprise systems, software applications, and computerized analytical systems.
  • Continuous improvement of the effectiveness of local procedures and protocols for maintaining compliance with corporate procedures and policies, as well as with relevant government regulations for GSK markets, in a manner seeking opportunities for risk-based approaches.
  • Serve as the principal validation member and/or Lead on project teams.
  • Participate in development of requirements and specifications.

Specific Accountabilities:

  • Oversight of and participation in the development and execution of approved procedures and 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. Ensure both technical and procedural content of deliverables reflect current procedures, government regulations, and industry practices. Organization of, and coordination of validation activities with internal clients and stakeholders in a manner that satisfies procedural and operational requirements.
  • Supervision, management, and mentoring of other validation personnel with the objective of completing validation related tasks in a timely manner and within budget, while providing quality and effective deliverables.
  • Interface with staff in Operations, Technical Services, Project Engineering, Quality Control & Compliance and Quality Assurance to coordinate resources and complete validation activities in a timely manner. Lead the effort to gain approval of validation protocols, reports, and procedures.

Contact information:

You may apply for this position online by selecting the Apply now button.

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