Job Description

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.

Position Description: Process engineer will focus on the design, operation, control, and optimization of engineering upstream & downstream processes for the manufacture of vaccines.

Functions, Duties, Tasks:

Provide stewardship for process and equipment including:

• Review the basis for the qualification of equipment and ensure that the equipment/system is appropriate for intended purpose.
• Ensure significant changes, maintenance and other interventions do not impact the qualified state of the equipment & provide maintenance oversight for process equipment.
• Conduct or oversee periodic reviews of direct impact facilities, utilities equipment and systems to verify that they remain in state that is fit for their intended use.
• Create & revise qualification packages for direct impact systems & work with TS/MS to ensure the accuracy of process flow documents.
• Provide oversight to less experienced engineers.

Implementation and optimization of process systems:

• Serve as local subject matter expert for process engineering systems.
• Ensure process operations comply with all health, safety, and environmental policies and procedures.
• Ensure process operations are in alignment with current site interpretations of GMPs & Elanco quality standards.
• Perform/ oversee Haz-ops and other process safety reviews.
• Know and understand throughput and capacity, and implement improvements and problem solving to optimize the system performance.
• Network with system users to ensure their needs are always met.

Execute local engineering projects:

• Provide process engineering support to project team.
• Participate as required in teams, committees, or other groups to achieve goals.
• Work with project requester to determining the scope of the project.
• Write user requirements document.
• Complete environmental assessments
• Write and execute commissioning documents to verify project success.
• Revise drawings and P&IDs as needed and organize drafting updates.
• Confirm CADD revisions and sign drawings.
• Assist in development of training plans & execute training as required.
• Review, revise & create process engineering documentation, validation requirements & user requirements as required.
• Write change management, incident reports, and complete corresponding action items.
• Act as investigation lead for deviations related to process systems and apply root cause analysis to the investigation.

Other duties:

• Complete documentation review for items generated or completed by the other process engineers and technicians. Provide technical assistance and backup support as necessary to these individuals.
• Monitor all training requirements as defined in the ITP for this position and ensure that training is completed by the required completion date.
• Ensure that all necessary items are entered in the quality plan and that items are completed by the required date.
• Other duties as required.

Minimum Qualifications (education, experience and/or training, required certifications):

• A Bachelor\xe2\x80\x99s degree in Chemical or Mechanical Engineering is required.
• 5-7 years\xe2\x80\x99 experience with process engineering principles.
• Experience in a pharmaceutical, Biotech or related environment is preferred.
• Proven analytical thinking and trouble-shooting skills.
• Must have strong oral, written, and interpersonal communication skills.
• Demonstrated ability to work independently and be a self-starter.
• Proven ability to multi-task and must have strong high attention to detail.
• Experience in validation activities associated with aseptic process, technology transfer and process validations are preferred.
• Experience in FMEA, QRM, P&ID development, PFD development is preferred.
• Exposure to Lean-Six sigma principles in an asset.
• Experience in fermentation and cell technology is an asset.

Salary Range: The salary range for this position will be approximately $63,000 - $100,000 annually, which will be determined based on education and experience.

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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

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