Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Provide leadership and direction for the needs of Baxter’s HVAC and Mechanical Systems for Manufacturing Operations globally.
Maintain knowledge of the various plant
systems and requirements based on a global vision of the company along with local cGMP requirements.
Establish a consistent methodology for the design of cleanrooms and associated controlled environments.
Ensure that the controlled environments and process utilities meet cGMP standards, regulatory agency expectations, as well as Baxter internal standards and production needs.
Develop strategies and applications, which minimize capital costs and reduce operating costs.
Develop budgets for capital expenditures and ensure that these budgets, as well as project schedules and performance requirements are met.
Keep abreast of industry trends, emerging technologies, governmental standards and regulatory expectations worldwide.
Apply this knowledge to the resolution of complex problems and to the development of unique, appropriate and innovative design solutions.
Become the company’s recognized expert/troubleshooter of HVAC and associated Mechanical system related technical problems.
Specific Responsibilities Include:
Make recommendations as to problem determination and resolution.
Evaluate existing HVAC and process utility system modification plans for appropriateness and compliance with company goals and requirements.
Provide financial and engineering analysis of the need for repair, replacement or capacity expansion.
Monitor construction/installation start-up and system validation.
Provide crisis support/trouble shooting.
Support HVAC and cleanroom / controlled environment needs throughout the company.
Perform Energy and Water Balances with objective of reducing energy and water usage.
Responsible for the design, equipment selection and
specification, commissioning and qualification of critical pharmaceutical HVAC and Cleanroom systems, incorporating the recommendations of the ISPE, ISO, PIC/s, EU GMP Annex I and other global pharmacopoeias.
B.S. in Mechanical Engineering or equivalent plus a minimum of 10 years of
experience in the design, construction and troubleshooting of HVAC and
Mechanical systems coupled with a strong understanding of system costs is
Must be an innovative thinker with excellent verbal and written
Some travel, ± 25%, on a global basis will be necessary.