Senior Staff Engineer

Role Description

The Senior Staff Engineer will work within operations to support formulation/packaging along with validation/qualification activities.  As well, this role will be responsible for providing the technical program leadership 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 Formulation / 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.
• Assist with the authoring of batch records, protocols and SOPs. 
• Assist and/or perform initial qualification of new systems.
• New product evaluations as well as 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.
• Exercise judgment within defined procedures to determine appropriate actions.
• Facility support may be required during non-routine hours. 
• Travel to equipment manufacturers for factory acceptance testing will be required.
• 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.
• Develops equipment reliability plans that reduce the number of failures and minimizes the effects of failures that do occur.
• Provides “Design for Reliability” input to capital projects with respect to equipment specifications that create project approaches which minimize life cycle costs.

REQUIRED QUALIFICATIONS

• Degree in Engineering/related field
• 15+ years of related experience
• Experience in lean six sigma and applying continuous improvement tools
• Yellow / Green belt certification
• Understanding of statistical analysis
• Understanding of manufacturing and associated equipment and/or utility/facility systems and equipment. Experience within a pharmaceutical environment preferred.
• Knowledge of reliability principles and maintenance work processes.
• Project Management: proven experience with small or large projects
• Language Skills: Technical Writing required, along with effective written and oral communication
• Computer Skills:  Microsoft Applications, Minitab or comparable statistical software
• Leadership: knowledgeable of basic leadership principles

DESIRED QUALIFICATIONS

• Masters in Engineering / related field
• Black belt certification
• Experience in lean six sigma, value stream mapping, visual management, 5S, etc.
• Experience with AutoCAD or related software is preferred

Full timeRegularColleague

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