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Principal Engineer
1 month ago
The Principal Engineer is responsible for providing technical support to facilities, utilities, and building infrastructure at the Cleveland manufacturing campus.
Responsibilities include matrix-management of mechanics and operators, asset management, reliability of critical and non-critical utilities and infrastructure, and project management.
Responsibilities:
Provide technical assistance to maintenance and other departments for improving plant systems in a manner that meets FDA, Corporate, and plant specifications.
Support all critical systems (Distilled Water (WFI), Process Air, Environmental Air), HVAC systems, fluid systems (chillers, boilers, cooling towers, potable water, steam distribution, etc.) and electrical systems (plant power and controls).
Facilities/Utilities project management (inception through completion). Lead the Cleveland site Lean Energy Management Program.
Assist in reliability centered maintenance (RCM) and total productive maintenance (TPM) implementation with respect to utility systems.
Ensure compliance as it relates to PMs, maintenance documentation, training, quality, 6s, safety.
Provide a positive and equitable working environment emphasizing the Baxter Shared Values - Respect, Responsiveness, and Results.
Support and Emphasize the Safety and Quality commitments of the department and make decisions concerning these commitments within the area.
Provide direction of resources in the most efficient and productive manner possible.
Ensure compliance with all GMP rules, specifications, SOPs, and FDA requirements as required.
Sustain a clean and safe work area using 6S principles.
Learn, understand, and apply rigorous quality standards, Standard Operating Procedures (SOPs), and Current Good Manufacturing Practices (cGMP).
Qualifications:
BS in Engineering. 4-6 years' experience in a manufacturing environment with GMP (Medical device or Pharmaceutical) manufacturing facility strongly preferred. Experience with HVAC and clean rooms, boiler control room operations, WFI generation, energy reduction, and power distribution systems preferred.
Proven communication, administrative, and strong technical leadership skills with the ability to interface well with other departments and lead effectively and efficiently in a team environment.
Solid professional writing skills.
Ability to manage multiple priorities in a manufacturing plant setting.
Good assessment and solving skills (mechanical and electrical) with demonstrated and proven experience and background.
Good understanding of MSOffice products and enterprise-level systems (i.e. Coupa, Maximo, Trackwise, etc.).
Ability to understand regulatory and safety guidelines applicable to the medical device/pharmaceutical industry and industry in general.
Must have experience and knowledge with Lockout/Tagout, Confined Space Entry, Hot Work, and other permitting programs as well as other Safety Programs.
Interact with all levels of personnel to analyze and solve problems related to Facilities and Critical Systems Equipment in the support of manufacturing operations.
Ability to resolve and/or call out any personnel issues that arise as part of ongoing operations.
Knowledge of Best in Class Methods (Lean, Six Sigma, JIT, FIFO, etc.).
Ability to respond to detailed inquiries and present information to groups and department management.
Have good project management skills and ability to organize many projects and priorities as required, including financial tracking and cash flow forecasting.
Understand verbal and written safety and quality instructions and read and comprehend written work instructions, including words, schematics, and drawings.
Must have basic English written and oral communication skills adequate to communicate with other team members.