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The engineering manager is responsible for implementing and supervising engineering activities at the Cleveland Plant while maintaining compliance with current manufacturing practices, environmental health and safety guidelines, and other applicable regulations. The role involves leadership, problem-solving, supervision, and technical responsibilities in a manufacturing environment.
Job Responsibility:
Responsible for engineering and drafting departments
Supervise, lead, and coordinate engineering activities directly or through direct reporting supervisors
Provide project engineering/process engineering resources to support facility manufacturing operations
Integral part of the manufacturing technical response plan for equipment maintenance/reliability
Drive performance with employees by providing a positive and equitable work environment emphasizing respect, responsiveness, and results, as well as applying the talent management process
Support and maintain all environmental, health and safety programs, as well as all other plant activities to ensure a robust safety culture and environmental regulatory compliance
Facilitate and verify appropriate training for all team members
Inspect, monitor, assess, and assure the facility and manufacturing equipment remains cGMP compliant and in a constant state of audit readiness
Ensure assigned projects and work are completed per the commitment date
Analyze, propose, and correct long-term solutions to existing and repeating problems
Drive the procurement and installation of new equipment
Coordinate, oversee, and manage contractors as needed to meet the responsibilities of the department
Support and encourage all plant activities
Must perform all other duties and responsibilities as determined by supervision/management.
Requirements:
BS degree in engineering subject area with 5-7 years of manufacturing engineering experience or equivalent manufacturing experience
5+ years of demonstrated effective supervisory skills
5+ years engineering/manufacturing experience
FDA/cGMP experience preferred
Must have demonstrated interpersonal and leadership skills with the ability to interface well with personnel of all levels
Must have ability to understand and follow cGMPs, FDA guidelines, and other regulatory guidelines applicable to the medical/pharmaceutical industry
Demonstrated ability to manage multiple priorities in a manufacturing setting and prioritize responsibilities of self and direct reports appropriately
Must be able to supervise multiple groups/departments
Able to work and facilitate a team-oriented environment
Possess problem solving skills using cause mapping and A3’s
Have organizational and administrative skills
Strong communication skills (both verbal and written)
The ability to analyze and interpret scientific and statistical data
Must have strong skills for operation and controls of manufacturing equipment and processes
Able to work in controlled environment requiring special gowning
Microsoft Office and Microsoft Project experience is preferred
Project Management experience is preferred
Six Sigma Master Black Belt Certification or industry standard equivalent is preferred
Lean Manufacturing skills and experience is preferred.
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