Process Engineer

Job Title

The ideal candidate will use industry best practices and their expertise in regulatory requirements to measure, analyze and specify requirements that lead to best-in-class quality products and design for manufacturing. We are looking for a highly motivated candidate, who can work cross-functionally to execute to the validation plan as well as material qualifications that come up as required.

Lead nonconformance investigations and drive CAPA using structured RCA (e.g., 5-Why, fishbone, fault tree) and Lean Six Sigma tools.

Support manufacturing and troubleshoot process related issues.

Lead projects relating to the development and optimization of consumables used in Zoetis' diagnostic products, ensuring deliverables and project timelines are met.

Implement changes including initiating change control, performing impact assessment and evaluating risk for non-conformances or process improvements.

Assist vendor in completing deviations, CAPAs to meet delivery timelines.

Develop and execute protocols and reports to quality equipment and processes. Use risk-based approaches for validation strategies, including acceptance criteria and sample sizes.

Collaborate with site operations on projects to increase production capacity or deliver productivity savings of consumable components.

Support continuous improvement projects.

Collaborate with procurement to identify and qualify new vendors.

BS in a field of Science or Engineering (Mechanical and Chemical preferred) or equivalent years of experience in Process Engineering.

Relevant advanced degree or training / certification in Process Engineering preferred.

5+ years' experience in GMP manufacturing, preferably in diagnostics or biodevice industries.

Understanding of cGMP

Application of Lean/Six Sigma Manufacturing tools (Greenbelt is a plus)

Project management experience

Able to work in a team and independently

Statistical analysis, including DOE, is a plus

Able to influence others with data-driven decisions

Good written and oral communication skills

Proficient in English

Proficient with Microsoft programs, Word, Excel, PowerPoint, etc.

This position requires on site presence in a manufacturing environment. Physical requirements include the ability to lift up to 50 pounds, stand or walk for extended periods, and work in areas with moving mechanical parts and varying noise levels. Personal protective equipment (PPE) is required in accordance with facility safety protocols, which may include safety glasses, hearing protection, steel-toed footwear, and other equipment as designated by area-specific requirements.