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Kalamazoo, Michigan, United States
Onsite
The 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 support to investigate and address process deviations and corrective actions.
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. Will need to comply with cGMPS in a FDA regulated environment.
Responsibilities will include:
• Act as a subject matter expert for the Formulation / Packaging areas.
• Use data analytics to drive process improvements and troubleshooting, including process capability analysis for periodic product reviews
• Support deviation investigations to identify root causes and implement corrective actions.
• Authoring of change control, validation protocols
• New product/material 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 such as; tech transfers, new product introductions, cost improvement projects.
• Assist with the authoring of batch record and standard operating procedures
• Facility support may be required during non-routine hours.
• Travel to equipment manufacturers for factory acceptance testing will be required as needed
REQUIRED QUALIFICATIONS
• Degree in Chemistry or Engineering /related field or 15+ years Pharmaceutical experience
• 5+ years of related experience
• Experience in applying continuous improvement tools
• Understanding of statistical analysis
• Understanding of manufacturing and associated equipment and/or utility/facility systems and equipment. Experience within a pharmaceutical environment preferred.
• 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
• Aseptic Manufacturing Experience
• Masters in Engineering / related field
• Green/ Black Belt Six Sigma certification
• Experience in lean six sigma, value stream mapping, visual management, 5S, etc.
Full time
Regular
Colleague
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