(Archived) Manufacturing Engineer

As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

The Process Engineer is responsible for supporting the design, operation, control and optimization of assets supporting technical processes at the Elwood, Kansas monoclonal antibody (mAb) manufacturing facility. The position is 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. The process engineer plays a key role in day-to-day operations as well as design and delivery of local and major capital projects.

Functions, Duties, Tasks:

Process Engineering

• Provide technical support and engineering solutions for process and equipment-related issues including support for production staff during manufacturing activities.
• Provide technical support for maintenance activities and help troubleshoot difficult problems
• Understand the basis for the qualification of equipment and ensure that the equipment / systems are appropriate for the intended purpose.
• Ensure equipment and processes are operating in an expected state of control, and in alignment with regulatory commitments, GMPs and all relevant Elanco standards.
• 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 changes, maintenance and other interventions do not impact the qualified state of the equipment and provide maintenance oversight for process equipment. Ensure any changes are documented appropriately through the change management system.
• Use data-driven analysis of process and equipment to understand performance and capacity. Identify, recommend, and implement improvements to optimize system performance.
• Ensure process operations comply with all health, safety, and environmental policies and procedures. Participate in Haz-ops and process safety reviews and identify / mitigate hazards of manufacturing processes and equipment.
• 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.
• Attend and complete necessary training as required in order to stay current with industry standards.

Project Delivery

• Provide process engineering support to project teams, including delivery of local and major capital projects.
• Participate in design, development, execution, commissioning, qualification, and validation activities for all projects and equipment procurement. 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.
• Act as process and equipment subject matter expert in project teams and committees.
• Create, review and revise relevant documentation including user requirement specifications, P&IDs, PFDs, safety and environmental assessments, commissioning and qualification documents, etc
• Prepare change management plans and complete corresponding action items.
• Collaborate with team members to identify potential risks, sources of variability, improvement, and value engineering opportunities to maximize project return and technical success.

Basic Minimum Qualifications:

• Bachelor’s degree (or equivalent) in a science or engineering discipline.
• 3+ years’ experience in the pharmaceutical, biotechnology, or a related industry.
• Proven analytical thinking and problem-solving skills.
• Working knowledge of cGMP standards and/or experience working in a regulated environment.
• Demonstrated success operating in cross-functional teams.
• Self-motivated team player with the ability to work, prioritize, and deliver results with minimal supervision.
• Strong verbal, written and interpersonal communication skills.
• Strong organizational and computer skills.

Additional Preferences:

• 5+ years’ experience in the pharmaceutical or biotechnology industry.
• Experience in capital project design, development, and execution.
• Understanding of monoclonal antibody / recombinant protein manufacturing processes.
• Experience in commissioning, qualification and validation activities associated with aseptic processes, technology transfers and new product commercialization.
• Experience with SAP, ERP, AutoCAD, Veeva Vault.
• Understanding and application of RCI, FMEA and QRM tools.
• Working knowledge of USDA and/or EU GMP regulations for veterinary biologics.

Other Information:

• Day shift position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
• Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
• Minimal travel requirements < 5%.

Notification of Drug testing and Background Checks

Elanco conducts urinalysis drug testing as a mandatory part of its pre-employment application and background check process after acceptance of a conditional offer of employment by an applicant. The drug testing will be conducted by a certified laboratory/testing service selected by Elanco, in accordance with the procedures required by applicable state and federal law. Additionally, Elanco requires successful completion of a urinalysis drug test if it has reasonable suspicion that an employee is under the influence of drugs or alcohol which adversely affects or could adversely affect the employee's job performance as allowed by applicable law. Tested applicants will be given a copy of any positive test result. All test results shall be considered confidential and shall not be disclosed by Elanco, other than to those persons for whom such disclosure is necessary. Positive test results, or a refusal to consent to and participate in pre-employment drug testing, shall be grounds for denial of employment. Cooperation in scheduling the testing is important for processing an application for employment. By signing your acceptance to an offer of employment, you consent to be drug tested and acknowledge you have thoroughly read the foregoing notice and policy, and you understand and agree that in order to be considered for employment with Elanco, you will be required to comply with Elanco's drug testing policy. Elanco's background check requirements also include but are not limited to an acceptable criminal background check, educational verification, job history verification and motor vehicle report (if required to drive a company vehicle). If appropriate for the role, as outlined on the job posting, successful completion of Post Offer Exam, Work Simulation and/or Administrative Skills Testing may also be required.

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