GMP Engineering Manager – Formulation & Packaging

Zoetis; Portage (MI); On-site; USD 100,000 - 140,000; Full time

Benefits offered by this job

Healthcare benefits

Retirement savings plan

Accommodations if requested

Job summary

Zoetis is seeking an Engineer to support formulation/packaging within operations in the US. You will apply data analytics to drive process improvements, address deviations, and support corrective actions in a FDA-regulated environment.

You will work in cross-functional teams on tech transfers, new product introductions, and cost-improvement projects, and you will draft batch records and validation protocols. Some non-routine hours and travel for FAT may be required.

Qualifications

• Degree in Chemistry or Engineering or related field; 15+ years pharma experience preferred.
• 5+ years of related experience.
• Experience applying continuous improvement tools.
• Understanding of statistical analysis.
• Understanding of manufacturing equipment and facilities in pharma.

Responsibilities

• Act as SME for 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

Skills

Data analytics

Process improvement

Root cause analysis

Technical writing

Communication

Leadership

Project management

Continuous improvement

Statistical analysis

Education

Degree in Chemistry or Engineering / related field

Tools

Minitab

Job description

Zoetis is seeking an Engineer to support formulation/packaging within operations in the US. You will apply data analytics to drive process improvements, address deviations, and support corrective actions in a FDA-regulated environment.

You will work in cross-functional teams on tech transfers, new product introductions, and cost-improvement projects, and you will draft batch records and validation protocols. Some non-routine hours and travel for FAT may be required.