63877BR
Business Title Sr Engineer
Business Global Quality
Country US
State/Province Illinois
Location of Position Round Lake, IL
Shift_ 1st
Job Description
This Senior Engineer position is in the Quality Management organization at the Round Lake Drug Delivery aseptic pharmaceutical manufacturing facility. The incumbent will be expected, with some guidance, to lead teams to complete small to medium validation projects. This individual shall ensure that products and processes meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. This position will typically focus two or more engineering disciplines related to equipment, software, process, control system and critical system validation. The incumbent will be responsible for initiating and ensuring proper documentation and training within the scope of validation. This includes preparation of detailed, accurate validation schedules, interfacing with Manufacturing, Process Engineering, Microbiology and Chemistry Laboratories.
Communicate project and task status to project team members, team leaders, and management on proactive and timely basis.
May also be required to present on projects to the Drug Delivery management team, FDA, Drug Partners, and other entities with respect to validation projects.
Expected to participate in the execution of the change control process, from the initiation through closure. Must have the ability to define the requirements for Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification and Validation Maintenance packages.
Responsibilities may also include leading a team of individuals in the execution of failure mode analysis, statistical analysis and design of experiments for small to medium scope projects.
Job Requirements
Must have the ability to prioritize and execute multiple project tasks.
Display a solid understanding of validation practices in multiple disciplines.
Ability to lead cross-functional teams, with some guidance.
Must be able to provide solutions that reflect understanding regulatory requirements, business objectives and cost implications.
Ability to communicate with respect to technical or project management issues, both verbally and in written form.
Must not be allergic to Penicillins or Cephalosporins.
Minimum of a BA or BS in Engineering,
A minimum of 2 – 4 years of experience in validation within a pharmaceutical, biotech or related industry is preferred
Doing Work that Matters Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at http://www.careers.baxter.com/. EOE M/F/D/V.