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Validation Project Manager


Location: Durham, NC
Job Category: Other Area(s)

  • Responsible, for the project planning, organization, execution, and lifecycle maintenance of site validation program elements in coordination with multi-site stakeholder organizations (engineering/facilities, manufacturing, process development).
  • Ensure that the planning, writing, editing, transmission and related support to validation plans, protocols, and regulatory summaries are planned and conducted in alignment within approved schedule commitments.
  • Ensures that the compilation and analysis of related protocols and report writing validation data are scientifically sound to support the process and equipment & product quality specifications, error free, and completed within schedule parameters.
  • Develop, review, and approve documentation relating to equipment (including automation), cleaning, and process as well as other subject matter areas as needed (QC methods, shipping, IT)
  • Support the review and approval of engineering and process development reports and specifications, Detailed Process descriptions, Campaign summaries, URS/FRS/DDS, FAT, SAT, P&IDs, and Engineering Change Management documentation.
  • Conduct and approve validation assessments and risk analyses for equipment / systems and processes * Ensure that support for the writing, editing, and QA monitoring of actions reports of non - compliance, CAPAs, and change controls related to validation activities are completed in a timely manner;
  • Support project management efforts by assisting with organizing and collection of data and status reports for projects and programs within areas of responsibility
  • Demonstrate through team collaborations, the ability to contribute to the development of new or improved validation practices by identifying more efficient & compliant approaches to typical practice or problem scenarios. Perform technical and supervisory duties with minimum of supervisory intervention.

Qualifications:

  • Advanced Science/Engineering degree with 6 years and/or Bachelor Science/Engineering with 8 years of experience in pharmaceutical manufacturing or science dealing with similar programs and/or within his/her scope of activities and responsibilities.
  • Proven experience in project development and execution of cGMP compliant lifecycle validation programs (facility, equipment, and process). Experience with cGMP manufacturing operations process development preferred. Knowledge and experience with biological manufacturing systems and equipment preferred.
  • Thorough understanding of applicable cGxP and applicable regulations/guidance and ability to interpret and apply regulations to complex issues to make risk management recommendations.
  • Proven competencies with analyzing and anticipating potential problems/issues, planning next steps, and providing visibility and timely reporting to supervisor or project teams along with ability to independently perform work tasks without technical advice or routine supervisory interventions.
  • High level of proficiency in validation test design and heuristic approaches to problem solving, protocol execution, and regulatory report writing, with mastery of good documentation practices. Excellent communication skills both written and oral in a teamwork/project environment required with experience in various office and project management software applications.

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