Validation Program Manager

Baxter International Inc., assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
Under the general direction of the Validation Department Manager, the Validation Program Manager collects, assembles, reports on project data and coordinates all sponsored Computerized Systems, Process Equipment, Facilities and Critical Systems and Cleaning Validation projects at the LA plant. Ensure successful project initiation, communicate project status and critical project milestones, elevate roadblocks for resolution and manage project change to ensure stakeholder awareness and support and successful project completion. Act as a Project Management Advisor when appropriate to facilitate the application of the Project Management Practices, including phase reviews on projects, to assure that projects are conducted on scope and within time and budget, while minimizing risk.1) Establish and maintain visibility of the status and issues on all active validation projects across the plant including but not limited to those being led by Computerized Systems, Process Equipment, Facilities and Critical Systems and Cleaning Validation. This includes all capital, expense and new product-related projects. Communicate status of projects in a clear and concise format.2) Consult with all Validation Project Team Leaders to assure projects are conducted according to prescribed project management practices.3) Establish, develop and drive Good Validation Practices in all projects undertaken.4) Participate in and facilitate the harmonization and coordination of efforts between teams; such as, Quality Engineering Validation, Engineering, Manufacturing, Quality Control, Technical Services and Regulatory.5) Coordinate and facilitate project phase reviews for capital and new product-related projects.6) Partner closely with the Validation Managers, Engineering Managers, Facilities Manager, Technical Services Director, Laboratory Managers and Manufacturing Managers to conduct projects effectively and efficiently.7) Drive continuous improvement of the project management practices deployment.8) Develop and maintain project management performance metrics.9) Facilitate project prioritization with SLT as needed, and coordinate/track project schedules.10) Track validation assessments, Commitments, Corrective Actions, ERs and DCERs to ensure Validation commitments are met on time and that related activities are coordinated between the validation teams.11) Work with other Baxter and customer project teams to drive successful project outcomes and lessons learned.Qualifications
Strong project management skills based on demonstrated practical experience running multiple successful technical projects. PMP certification preferred.Excellent leadership, interpersonal and presentation skills.Must have a thorough understanding of the interfaces between functions in order to coach leaders and generally facilitate optimal project progress.Must have good organization, prioritization and follow-up skills. Ability to overcome obstacles and to deliver results.Must have excellent communication skills in order to effectively communicate with all levels of professionals, both internal and external.BS in Engineering or BS in related scientific discipline with equivalent experience.Minimum 8-10 years of experience in project management, related to engineering, construction or validation preferably in the Pharmaceutical or Biotech industries.In general, the position requires a combination of sedentary work and walking around attending meetings with personnel in the facility.Must be able to work overtime as required.Inside working conditions.5% travel.
As a global leader dedicated to building the best team in health care, Baxter offers competitive compensation and full benefits. To view other opportunities at Baxter, please visit our Careers@Baxter site. EOE M/F/D/V
REQUIREMENTS
Please see Job Description