GMT Manager Engineer

Zoetis • Kalamazoo, MI

2d

About The Position

The Engineer works 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, and collaborates with cross-functional teams to identify and implement safety, quality, efficiency, and cost improvements to equipment and processes. The position operates in an FDA-regulated environment and requires compliance with cGMPs.

The role also supports technical projects such as technology transfers, new product introductions, and cost-improvement projects, with responsibility for delivering projects on time and within budget. Facility support may be required during non-routine hours, and travel to equipment manufacturers for factory acceptance testing may be required as needed.

Requirements

• A degree in Chemistry, Engineering, or a related field, or 15 or more 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 and 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

• Experience in a pharmaceutical environment.
• Aseptic manufacturing experience.
• A 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 approaches.

Responsibilities

• Act as a subject matter expert for the formulation and 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, such as technology transfers, new product introductions, and cost-improvement projects, to deliver them on time and within budget.
• 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: Mid Level