Role Description
The Engineer will work within operations to support formulation/packaging and validation/qualification activities. As well, the Engineer will be responsible for leading technical programs and implementation activities to maximize the maintenance related uptime and operating efficiencies of equipment and facility assets, by monitoring the status of reliability maintenance programs relative to corporate program strategies. These activities help minimize costs and contribute to the profitability and performance of the business.
The ideal candidate will also work in cross-functional teams to identify and implement safety, quality, efficiency and/or cost improvements (CIP's) on equipment and processes within operations.
Responsibilities will include:
- Act as a subject matter expert for the Packaging areas.
- Support daily activities of packaging operations. This includes troubleshooting, investigating root cause of deviations, implementing corrective/preventative actions, and implementing process improvements.
- Lead and author deviation investigations to identify root causes and implement corrective actions.
- Execute validations/line trials to support projects, including the authoring of change control documents.
- Assist with the authoring of batch records, protocols and SOPs.
- Periodic review and/or routine troubleshooting of system failures or deviations, including root-cause analysis and corrective/preventative action implementation.
- Provide support for validation assessments/evaluations, including using Quality Risk Management tools.
- Provide project management of technical projects to deliver projects on time and to budget.
- Facility support may be required during non-routine hours.
- Travel to equipment manufacturers for factory acceptance testing will be required.
- Promotes the use of Reliability Engineering concepts and tools to the Engineering and Production departments.
- Communicates changes and updates resulting from project meeting activities, strategy and continuous improvement efforts, and Project implementation activities.
- Establishes guidelines and specifications (i.e.: Task, Frequency, Materials, Skill, Calibration parameters, etc.) for properly implementing equipment Preventive Maintenance and equipment health activities.
- Administers and oversees the PM / Calibration Optimization Program.
- Performs reliability analysis (FRACAS, FMEA) to identify root causes of equipment issues.
- Identifies chronic equipment deficiencies through "Bad Actor" analysis.
- Develops procedures and specifications for the reliability maintenance aspects for existing and new equipment.
- Generates change control documentation as required by reliability initiatives (i.e. FRACAS, FMEA, Improvement Projects, etc.)
REQUIRED QUALIFICATIONS
- Degree in Engineering/related field
- 5+ years of related experience
- Experience with AutoCAD or related software is preferred
- Experience in lean six sigma applying continuous improvement tools
- Basic understanding of statistical analysis
- Basic understanding of manufacturing equipment. Experience within a pharmaceutical environment preferred.
- Language Skills: Technical Writing required, along with effective written and oral communication
- Computer Skills: Microsoft Applications, Minitab or comparable statistical software
DESIRED QUALIFICATIONS
- Experience in lean six sigma, value stream mapping, visual management, 5S, etc.