GMT Manager Engineer

Zoetis • Kalamazoo, MI

3d

About The Position

The Engineer will work within operations to support formulation and packaging, as well as validation and qualification activities. The role provides technical support for investigating and addressing process deviations and corrective actions. The ideal candidate will work with cross-functional teams to identify and implement safety, quality, efficiency, and cost improvements on equipment and processes within operations. The position requires compliance with cGMPs in an FDA-regulated environment.

Facility support may be required during non-routine hours. Travel to equipment manufacturers for factory acceptance testing will be required as needed.

Requirements

• Degree in Chemistry, Engineering, or a related field, or 15+ years of pharmaceutical experience.
• At least 5 years of related experience.
• Experience applying continuous improvement tools.
• Understanding of statistical analysis.
• Understanding of manufacturing and associated equipment and/or utility/facility systems and equipment.
• Proven project management experience with small or large projects.
• Technical writing skills and effective written and oral communication skills.
• Computer skills, including Microsoft applications and Minitab or comparable statistical software.
• Knowledge of basic leadership principles.

Nice To Haves

• Pharmaceutical environment experience.
• Aseptic manufacturing experience.
• Master's degree in Engineering or a related field.
• Green Belt or Black Belt Six Sigma certification.
• Experience with Lean Six Sigma, value stream mapping, visual management, 5S, or similar methods.

Responsibilities

• 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.
• Author change controls and validation protocols.
• Evaluate new products and materials and support validation assessments and evaluations, including use of Quality Risk Management tools.
• Manage technical projects to deliver them on time and within budget, including tech transfers, new product introductions, and cost improvement projects.
• Assist with authoring batch records and standard operating procedures.
• Provide facility support during non-routine hours as required.
• Travel to equipment manufacturers for factory acceptance testing as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager