Principal Engineer - Process Engineering

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Organization Overview:

The Process Engineering function is part of the Maintenance and Engineering Department that provides technical expertise and support to Operations ensuring compliance with cGMP, HSE guidelines and regulations, company standards and business practices.  The primary areas of support include technical expertise (process and equipment), manufacturing and business process improvements, compliance with business systems, and people development.

Responsibilities:

• Technical leadership - Provide expertise as equipment/asset expert/steward for the areas supported to design, improve and maintain an efficient manufacturing processes. Establish and maintain technical information of the process and unit operations within the manufacturing process.
• Develop and monitor process and capacity indicators to identify and address performance issues and identify improvement opportunities.
• Understand process hazards and participate/lead in Process Hazard Reviews (PHR) and assessments. Implement PHR recommendations. Assure safety processes are in place (i.e. LOTO, Line breaking, etc.).
• Develop specialized technology/unit operations knowledge and provide training to operations as content expert for manufacturing standard operating procedures (SOPs).
• Perform troubleshooting and investigation on unexpected issues. Own equipment related deviations, CAPAs and changes. Lead or participate in investigations, problem-solving activities such as root cause analysis, FMEA, problem analysis and in development/implementation of countermeasure for quality, safety, environmental events.
• Lead efforts in design, selection, installation, qualification, operation, maintenance, and reliability of process equipment and facilities.
• Perform and summarize improvement opportunities in technical reports, investigations, plant/lab trials, data analysis and process modeling.
• Active participation and engagement in the meetings and activities of the assigned process team and safety/environmental sub teams.
• Own the qualified state of their equipment and monitor according to the defined strategy.
• Own Commissioning & Qualification (C&Q) strategy and execution for the assets, including requirements, design, and verification.
• Have holistic understanding of Process Validation (and associated equipment, facilities, and computer systems), assessment of significant changes, maintenance and other interventions, involvement with PM Plans and spare parts list.
• Ensure process complies with current industry regulatory expectations, new regulations, and corporate policies and programs for Quality, Health and Safety & Environmental, Process Safety.  

Basic Requirements:

• B.S. in Engineering (Chemical or Mechanical)
• Minimum of five (5) years of experience in pharmaceutical (API/Chemical) operations.  Demonstrated Technical knowledge in Process Equipment requirements, specifically those related to Chemical Operations.
• Experience in PSM (Process Safety Management) process

Additional Skills/Preferences:

• Biotech/Chemical Operations; Spray Dispersing Drying Operations.
• Bilingual (English/Spanish) with strong written and oral communication skills
• Strong leadership and organizational skills
• Knowledge in managing multiple project objectives or assignments.
• Technical Writing
• Strong customer service focus

Additional Information:

• Available to work or provide support to a 24/7 operation, if necessary
• Availability to travel within and outside Puerto Rico and U.S.
• Work as a resource in other strategic areas of the business, based on business needs.

Important Notice: In order to maintain the excellent reputation of our company, the quality of our products, and the safety of our working environment, the company will take all reasonable measures to ensure that drug abuse by employees or other persons does not jeopardize the safety of our operations or the quality of our products or adversely affect in any way the company or its employees. The company recognizes that drug use both on and off the job can be detrimental to the company and its efforts to provide a drug-free workplace. Even if prescribed under a state medical marijuana law, marijuana remains illegal under federal law. Marijuana is considered unauthorized by Lilly.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

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