Details: SummaryThe position will support the development of a new, state-of-the-art plasma fractionation facility that will bring Baxter additional capacity for testing, purification, and fill and finish for its biologic medications.Position will play a leadership role as the Engineering lead/representative for a specific discipline or area of the project. Responsible for developing, evaluating and implementing cost-effective equipment, facility and utility engineering solutions for a greenfield manufacturing facility in a fast-paced cGMP, biotechnology environment. This includes all phases of the project including conception, developing justification, presenting to management, preparation of capital impact analysis, budget management, project timeline creation and management, detailed design, creating specifications (Design/Functional/System) and vendor/contractor scopes-of-work (RFQs/RFPs), competitive bidding, placing purchase orders, contractor and consultant supervision, creating and executing change control documentation, performing factory and site acceptance tests (FATs/SATs), installation, commissioning, debugging, optimization, supporting Validation and training maintenance and manufacturing personnel.Essential Duties and Responsibilities1.Work independently with minimal supervision to execute all facets of projects. Expected to make suggestions on improvements based on supporting data, technical knowledge, engineering principles and current industry practices.2.Manage medium to large sized components of the green field project with minimal assistance.3.Lead the planning and execution of medium and large sized capital projects related to production and/or facility requirements.4.Support the planning and execution of large sized capital projects by working in cross-functional teams as the Engineering lead/representative for a specific discipline or area.5.Define project scopes, prepare cost estimates, and provide justification for major capital budget items.6.Manage and control the spending of approved project funds.7.Create an initial project timeline and manage the project schedule.8.Drive projects to completion and meet timeline and budget objectives9.Able to participate and make suggestions for capital planning, spending, and tracking.10.Create or update written Stand Operating Procedures (SOPs) related to project assignments.11.Create or update technical support specifications (Design/Functional/System) related to project assignments.12.Supervise contractors and junior level engineering personnel on project and activities.13.Demonstrate continuous improvement with respect to increasing job knowledge and proficiency related to engineering in the biopharmaceutical industry, as well as technical understanding/problem solving capability.14.Stay current with biopharmaceutical industry best practices and technologies15.May perform other duties as assigned. Qualifications• Must have a demonstrated track record of successfully executing engineering projects, and supporting facility issues, in a FDA-regulated manufacturing environment. Green field experience is desireable. • Possess knowledge of core principles in various engineering disciplines including manufacturing (ie. cell culture/fractionation//purification/aseptic filling/packaging/cGMP facility design), support systems (WFI/RO/clean steam/compressed gases/HVAC) and facility design. • Must have excellent organizational, verbal and written communication skills; Able to efficiently communicate with cross- functional teams and management on recommended course of action, with minimal assistance. • Must have proficient computer skills and be experienced using MS Office software (Word, Excel and Powerpoint) and MS Project. • Must have the ability to effectively lead Engineering projects, coordinate contractors, and drive results. Direct experience with manufacturing operations and biotechnology processes is strongly preferred. • Must possess basic knowledge of core principles in various engineering disciplines (fluid mechanics, heat transfer, thermodynamics etc…), as well as be experienced applying project management methodology. • Must have good interpersonal skills and be able to work effectively and efficiently in a team-based environment. • Knowledge of programmable logic controllers, DCS, instrumentation and controls highly desirable. • Has the ability to prioritize multiple tasks and work on multiple projects simultaneously. • Must be a self-starter, detail oriented and able to work independently with minimal supervision. • Must embrace working in a fast-paced, team-oriented, cross-functional environment.Education and/or experience B.S. degree required in an Engineering discipline with the preference being Chemical, Mechanical or Biomedical Engineering, with a minimum of 8-10 years of experience in an engineering role within the pharmaceutical, biotechnology or FDA regulated industry. A minimum of 5 years experience executing capital projects is preferred. Must have experience with equipment sanitary design principles and materials of construction used in the biopharmaceutical industry. Should also be knowledgeable with respect to one or more the following: aseptic processing and filling, lyophilization, capping, ultrafiltration, chromatography, centrifugation, filter press and other filtration systems, cGMP facility design (cleanrooms, ISO classes, HVAC), utility systems common to the biopharmacutical industry (e.g., WFI, RO water, compressed gases and clean steam), clean-in-place (CIP) and steam-in-place (SIP) equipment and cycles, air-handling-units, autoclaves, clean room design and operating principles . Must be familiar with cGMPs, Good Engineering Practices, as well as FDA and EU regulations. Basic knowledge of programmable logic controllers (PLCs), DCS systems and instrumentation (e.g., flow, pressure, temperature, level, conductivity, UV) and controls is desirable. Knowledge of support equipment such as air-handling units, solvent recovery,autoclaves and parts washers is also desirable.Baxter provides its employees with comprehensive compensation and benefits.To view other opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.baxter.com/about_baxter/careers . EOE M/F/D/V.
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