Consultant – Manufacturing Engineer

Elanco Tiergesundheit AG; Elwood (KS); On-site; USD 98,000 - 150,000; Full time

Job summary

Elanco is seeking a skilled engineer to support operation, control, and optimization of manufacturing assets at the Elwood, Kansas monoclonal antibody facility. You will serve as a subject matter expert for processes and equipment, participating in development, data analysis, troubleshooting, technology transfer, and continuous improvement initiatives.

You will contribute to design, commissioning, qualification, and validation activities for major projects, ensuring operations stay in a

Qualifications

• Master’s degree in Engineering Management, Mechanical Engineering, or related field (foreign equivalent) with 1 year experience.
• Experience with IQ, OQ, validation, and GMP documentation.
• Familiarity with CAPA, deviations, change control and SOPs.

Responsibilities

• Support operation, control and optimization of manufacturing assets at Elwood, KS facility.
• Act as SME for process and equipment; engage in development, data analysis, troubleshooting, and technology transfer.
• Lead or support commissioning, qualification and validation activities for major projects.
• Ensure changes and interventions do not impact qualified state; provide maintenance oversight for process equipment.
• Document and track issues in the quality system; perform root cause analysis and corrective actions.

Education

Master’s degree in Engineering Management, Mechanical Engineering, a related field, or a foreign equivalent

Tools

IQ

OQ

Validation

GMP documentation

CAPA

Job description

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better - join our team today!

DUTIES

• Responsible for supporting the operation, control and optimization of manufacturing assets and technical processes at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility.
• Act as a subject matter expert with respect to the process and equipment and is engaged in development, data analysis, troubleshooting, technology transfer, and continuous improvement activities.
• Play a key role in day-to-day operations as well as local and major capital project equipment design, installation, commissioning, qualification and validation.
• Provide technical support and engineering solutions for process and equipment-related issues including delivery of local and major capital projects.
• Provide on-floor support to the Manufacturing teams regarding equipment and process troubleshooting.
• Ensure issues are identified and captured in the relevant quality management system, and that proper root cause analysis is performed with appropriate corrective and preventative actions assigned.
• Ensure equipment and processes are operating in an expected state of control, and in alignment with regulatory commitments, GMPs and all relevant Elanco standards.
• Ensure changes, maintenance and other interventions do not impact the qualified state of the equipment and provide maintenance oversight for process equipment.
• Ensure changes are documented appropriately through the change management system.
• Use data-driven analysis of process and equipment to understand performance and capacity and identify, recommend, and implement improvements to optimize system performance.
• Participate in design, development, execution, commissioning, qualification, and validation activities for major projects.
• This includes, but is not limited to, definition of project scope, development and analysis of design options, establishment of user requirements, selection of appropriate equipment, construction oversight, execution of commissioning and qualification activities, support for process validation, etc.
• Demonstrate strict adherence to relevant local, state and federal requirements, cGMP standards and Elanco policies and procedures.
• Exemplify "Safety First and Quality Always" mind-set.
• Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and technical success.
• Create, review and revise relevant documentation including user requirement specifications, P&IDs, PFDs, safety and environmental assessments, commissioning and qualification documents.
• Manage Quality events as assigned – Deviation, Change Control, CAPA etc.
• Prepare change management plans and complete corresponding action items.
• Understand the basis for the qualification of equipment and ensure that the equipment / systems are appropriate for the intended purpose.

REQUIREMENTS

• Master’s degree in Engineering Management, Mechanical Engineering, a related field, or a foreign equivalent plus 1 year post-baccalaureate experience in job offered or any research scientist related job titles.
• Applicants must have 1 year of experience in the following: (1) Working in medical device, pharma, or biotechnology, industry; (2) Installation Qualification (IQ), operational qualification (OQ), Validation, and Installation; (3) cGMP standards and experience working in a regulated environment; (4) GMP documentation, Safety, Standard Operating Procedures (SOP), Batch Documents, Change Control, Protocol Execution, and Deviation investigation; (5) Statistical Process Control (SPC) to monitor and control process parameters and for internal corrective actions; (6) development and analysis of design scope for manufacturing equipment; and (7) providing maintenance guidance for manufacturing equipment.

JOB SITE

1411 Oak Street, Elwood, KS 66024

SALARY

$98,234 - $150,300 per year

Any person may provide documentary evidence bearing on the application to the Certifying Officer of the Department of Labor at the following address: Certifying Officer U.S. Department of Labor Employment and Training Administration Office of Foreign Labor Certification 200 Constitution Avenue NW, Room N-5311 Washington, DC 20210 Phone: [phone] Fax: [phone]

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching life and our Elanco Healthy Purpose CSR framework - all to advance the health of animals, people and the planet. Learn more at www.elanco.com.