Production Process Engineer
SUMMARY OF POSITION:
The Process Engineer is the primary technical leader for the assigned process area. Implement projects to improve safety, quality, efficiencies, cost reductions, production capacity and equipment availability. This position requires the individual to lead teams and manage multiple tasks.
ESSENTIAL FUNCTIONS:
- Develop and maintain equipment replacement / rebuild program for the assigned process area.
- Partner with Operational Excellence Organization to integrate Six Sigma / Lean tools into the assigned process area.
- Develop and conduct Engineering Studies to determine Root Causes and corrective action plans.
- Serve as a technical resource (problem resolution) for the assigned process area.
- Manage process and equipment projects supporting assigned process area.
- Partner with Process Maintenance Organization to refine maintenance program (Preventive / Predictive Maintenance, Work Instructions, SOPs, Training Curriculum, etc.).
- Ability to effectively communicate with all levels of the organization, from operations to senior management, and with external customers (auditors, suppliers, etc.).
- Must strive for continuous improvement in all work activities.
- Comply with current Good Manufacturing Practices (cGMP).
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
- Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment. Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk. Report all safety and/or environmental incidents to management immediately.
- Assist Validation, Quality, Production, Training Organizations with Engineering Studies, protocols, procedure development, etc.
- Other duties as assigned with or without accommodation.
MINIMUM REQUIREMENTS:
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Education required/ preferred: |
Bachelor’s Degree in Engineering - preferably Mechanical or Industrial Engineering |
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Experience: |
Minimum 2 to 5 years Pharmaceutical or Biotech manufacturing experience (preferred) 2-5 years in Process Engineering experience (preferred) |
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Preferred Skills/Qualifications: |
Experience with automated packaging or liquid filling equipment Ability to read blueprints/schematics and Autocad drawings Six Sigma training and/or certification preferred (Greenbelt) Lean Manufacturing training and/or certification |
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Skills/Competencies: |
Must demonstrate leadership, willingness to change Strong project design and management skills Ability to work independently or with a cross functional team |
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Other Skills: |
Basic reading, writing and math skills |
ORGANIZATIONAL RELATIONSHIPS/SCOPE:
- Reports to Manufacturing Science and Technology Manager. Position must interact positively with all levels of the plant, as well as external customers (Equipment Suppliers, Contractors, Corporate, Auditors).
WORKING CONDITIONS:
- Work areas consist of a combination of normal office conditions and air-conditioned warehouse and production areas and non-air conditioned utility areas.
- Position does require use of various PPE including, but not limited to, steel toe shoes, hearing protection and safety glasses.
- Regulated Manufacturing Areas requiring gowning in compliance with SOPs.