GMT Manager Engineer

Zoetis; Kalamazoo (MI); On-site; USD 90,000 - 130,000; Full time

Job summary

Zoetis in Kalamazoo, MI, seeks an Engineer to support formulation and packaging within operations, and to partner on validation/qualification activities. The role emphasizes addressing deviations, implementing corrective actions, and delivering projects on time and budget.

You will work with cross-functional teams to drive safety, quality, efficiency, cost improvements (CIP), and apply data analytics, statistical tools, and QRM. Knowledge of cGMPs in FDA-regulated environment required.

Qualifications

• Degree in Chemistry or Engineering or related field.
• 5+ years of related experience in pharmaceutical/regulated environment.
• Experience applying continuous improvement tools.
• Understanding of statistical analysis.
• Understanding of manufacturing equipment and utilities in pharma.
• Project management experience with small or large projects.
• Strong technical writing and communication skills.
• Knowledge of basic leadership principles.

Responsibilities

• Act as SME for Formulation/Packaging areas.
• Use data analytics to drive process improvements and troubleshooting.
• Support deviation investigations to identify root causes and implement corrective actions.
• Authoring of change controls and validation protocols.
• Evaluations for new products/materials and validation assessments.
• Lead technical projects to deliver on time and budget (tech transfers, cost improvements).
• Assist with batch records and SOPs.
• Non-routine hours may be required.
• Travel to manufacturers for factory acceptance testing as needed.

Skills

Data analytics

Process improvements

Root cause analysis

Statistical analysis

Leadership

Technical writing

Education

Degree in Chemistry or Engineering

Masters in Engineering / related field

Tools

Minitab

Microsoft Office

Job description

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

Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at [e-mail] to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at www.Zoetis.com/careers site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.