Principal Engineer

Role Description

The Principal Engineer will work within operations to support formulation/packaging along with validation/qualification activities.  The ideal candidate will work in cross-functional teams to identify and implement safety, quality, efficiency and/or cost improvements on equipment and processes.  This role will be responsible for providing 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.

This role will also be responsible and accountable for engineering/maintenance mentorship program, working collaboratively with cross functional partners to ensure business continuity and placement of less tenured engineers.

Responsibilities will include:

• Ensures engineers are educated on expectations in role and can mentor technical competencies as engineers enter new areas. Designs schedule and creates regular check in points for feedback.
• Act as a subject matter expert in formulation/packaging areas.
• Support daily activities in 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
• Provide support for validation assessments/evaluations 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.
• Establishes guidelines and specifications (i.e.: Task, Frequency, Materials, Skill, Calibration parameters, etc.) for properly implementing equipment Preventive Maintenance and equipment health.
• Administers and oversees PM / Calibration Optimization. Provides technical assistance and expertise to other engineers’ assigned optimization activities to ensure compliance to requirements.
• Performs reliability analysis (FRACAS, FMEA) to identify root causes of equipment issues.

REQUIRED QUALIFICATIONS

• Degree in Engineering/related field
• 20+ years of related experience
• Proven track record with engineering mentorship / career development
• Experience within a pharmaceutical environment
• Experience in lean six sigma applying continuous improvement tools
• High level understanding of statistical analysis
• 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

• MBA in Engineering/related field
• Yellow/Green belt certification preferred. Black belt certification highly desired.
• Experience in lean six sigma, value stream mapping, visual management, 5S, etc.
• Experience with OSD research, development, and system qualifications

Full time

Regular

Colleague

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