Job Description

Senior Engineer

The Engineer will support Oral Solid Dose (OSD) formulation operations of weigh, blend, tablet compression, and tablet coating. As well, the Engineer will be responsible for leading technical programs and implementation activities to improve manufacturing processes and maximize the maintenance related uptime and operating efficiencies. 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 cost improvements (CIP’s) on equipment and processes within operations.

Responsibilities will include:

• Act as a subject matter expert for the assigned areas.
• Support daily operations activities. This includes troubleshooting, investigating root cause of deviations, implementing corrective/preventative actions, and implementing process improvements.
• Lead, execute and deliver annual Continuous Improvement Projects Lead and author deviation investigations to identify root causes and implement corrective actions.
• Execute qualification/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.
• Communicates changes and updates to stakeholders.
• 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.
• Establishes guidelines and specifications (i.e.: Task, Frequency, Materials, Skill, Calibration parameters, etc.) for properly implementing equipment Preventive Maintenance and equipment health activities.
• 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.

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.
• Degree in Chemical Engineering highly preferred

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