Manager, Facilities Validation

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.
Create and manage a Facilities and Critical Systems Validation group vision that aligns with the Validation Department vision. Manage the Facilities and Critical Systems Validation Group to ensure timely and compliant facilities and critical systems validation of the Los Angeles site. Based on significant technical expertise, participates as a key player with Engineering, Manufacturing and QA/QC, in facilities and critical systems validation project planning and execution including system and process specification, design, development, validation and implementation activities. Manages facilities and critical systems validation project plans and coordination of facilities and critical systems validation approaches and development of acceptance criteria, test plans and documentation for new processes and equipment. Reviews and approves complex facilities and critical systems validation documents and provides general direction to technical staff. Utilizes solid understanding of theories and practices of a variety of scientific and engineering disciplines to manage complex facilities and critical systems validation projects within boundaries of quality, time and budget.1) Lead the development and execution of facilities and critical systems validation project strategies crossing Engineering, Technical Services, Manufacturing, QA/QC and Regulatory disciplines; evaluate alternatives against agreed criteria. Responsible for defining scope of work for project teams.2) Develop and implement new facilities and critical systems validation approaches requiring integration of new technological advances.3) Plan and schedule facilities and critical systems validation projects. Responsible for defining scope of work, resources and duration for individual projects to meet site-wide validation and budgetary goals.4) Manage, identify, hire, develop and recognize technical staff to support Los Angeles site facilities and critical systems validation activities. Provide technical direction.5) Apply specialized scientific, engineering and validation knowledge in a creative way to a broad range of difficult facilities and critical systems validation problems.6) Review and analyze proposals to determine if benefits derived and possible applications justify expenditures. Responsible for preparation of facilities and critical systems validation project schedule and cost estimates. Monitors all project expenditures and cost tracking.7) Responsible for Facilities and Critical Systems Validation policies and defining procedures for the staff in accomplishing and documenting projects. Provides input on overall Validation department policy.8) Approve protocols and support documentation (engineering change requests, system change forms, etc.) in order to secure project release. This is a "technical approver" position.9) Proactively and regularly communicate with regions and plants (directly or through marketing) to update development progress and maintain region support.Qualifications
Must be well versed in validation disciplines (e.g. process and equipment validation methods and procedures) and have working knowledge of chemistry and microbiology. Must also possess working knowledge of regulatory requirements and new developments for facilities and critical systems validation.Knowledge of GMPs, FDA guidelines, purchasing practices and process validation.Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
Ability to design and influence in own area of expertise.
Be involved in at least one industry interest group.Has demonstrated effective supervisory skills.BS in related engineering discipline or BS in related scientific discipline with equivalent experience.8-10 years of relevant technical experience.Experience in handling multiple projects and leading cross-functional teams.In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.Activities may require work around chemicals such as alcohol, acids, buffers and celite that may require respiratory protection.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