Position SummaryWe are seeking an experienced
Process Engineer with strong
capital project and manufacturing support experience to join our team supporting operations at Lilly PR05 in Carolina, Puerto Rico. The selected candidate will provide technical leadership for manufacturing processes, process equipment, and capital projects while ensuring compliance with cGMP, safety, environmental, and engineering standards.
This role will support the planning, execution, commissioning, qualification, startup, and optimization of manufacturing and utility systems projects while driving continuous improvement initiatives across operations and engineering functions. The position requires extensive interaction with Operations, Maintenance, Quality, Technical Services, Validation, EHS, and external contractors. The responsibilities are aligned with typical Lilly Process Engineering functions, including process support, equipment stewardship, troubleshooting, qualification, investigations, and project execution.
Key ResponsibilitiesProcess Engineering & Manufacturing Support- Provide technical support for pharmaceutical manufacturing processes and equipment.
- Serve as process and equipment subject matter expert (SME) for assigned manufacturing areas.
- Monitor process performance, identify operational inefficiencies, and implement improvement initiatives.
- Lead troubleshooting activities for process, equipment, and manufacturing issues.
- Support investigations, root cause analyses, CAPAs, and deviation management.
- Develop and maintain process documentation, engineering studies, technical reports, and operating procedures.
- Support process validation, equipment qualification, and technology transfer activities.
- Analyze manufacturing data and recommend process optimization opportunities.
- Ensure manufacturing processes remain in a validated and compliant state.
Capital Projects- Lead and support capital projects from conceptual design through implementation and startup.
- Develop project scopes, technical specifications, cost estimates, schedules, and resource plans.
- Coordinate engineering contractors, vendors, and construction activities.
- Review and approve engineering deliverables, drawings, equipment specifications, and technical submittals.
- Support design reviews, constructability reviews, and risk assessments.
- Manage project budgets, schedules, milestones, and project documentation.
- Provide field engineering support during construction, commissioning, and startup activities.
- Ensure projects are executed in accordance with site procedures, engineering standards, and regulatory requirements.
Equipment & Facility Engineering- Support design, installation, qualification, operation, maintenance, and reliability of manufacturing equipment and facility systems.
- Participate in equipment selection, FAT/SAT activities, commissioning, and startup efforts.
- Review PFDs, P&IDs, equipment layouts, utility requirements, and process control strategies.
- Support equipment lifecycle management and asset reliability programs.
- Collaborate with maintenance and operations teams to improve equipment performance and uptime.
Compliance & Continuous Improvement- Ensure compliance with cGMP, FDA regulations, site quality systems, and EHS requirements.
- Participate in change control, validation, and quality system processes.
- Support Process Hazard Reviews (PHRs), risk assessments, and safety initiatives.
- Drive continuous improvement projects focused on safety, quality, capacity, reliability, and cost reduction.
- Benchmark industry best practices and implement innovative engineering solutions.
Minimum Qualifications- Bachelor's Degree in Chemical Engineering, Mechanical Engineering, or related Engineering discipline.
- Minimum of 5 years of engineering experience in pharmaceutical, biotechnology, medical device, or regulated manufacturing environments.
- Minimum of 3 years of capital project execution experience.
- Experience supporting GMP manufacturing operations.
- Experience with commissioning, qualification, and validation activities.
- Ability to manage multiple priorities and projects simultaneously.
- Fully bilingual (English and Spanish), written and verbal.
Preferred Qualifications- Professional Engineer (PE) or Engineer-in-Training (EIT) license.
- Experience within Lilly, FDA-regulated pharmaceutical facilities, or similar GMP environments.
- Knowledge of:
- Process Validation
- Commissioning & Qualification (CQV)
- Change Control Systems
- CAPA and Deviation Management
- Process Safety Management (PSM)
- Root Cause Analysis (RCA)
- FMEA and Risk Assessments
- Experience with:
- Utility systems
- Process equipment
- Clean utilities
- Manufacturing automation systems
- DeltaV, PI System, SAP, Maximo, TrackWise, Kneat, or similar platforms
Required Skills- Strong technical problem-solving and troubleshooting capabilities.
- Project management and coordination skills.
- Technical writing and documentation development.
- Effective communication and stakeholder management.
- Leadership and cross-functional collaboration.
- Strong organizational and analytical skills.
- Ability to work independently in a fast-paced manufacturing environment.
Work Environment- Manufacturing and engineering support environment.
- Occasional support to off-shift, weekend, or shutdown activities may be required.
- Ability to work in production, utility, and construction areas.
- Periodic travel may be required based on project needs.
Ideal Candidate ProfileThe ideal candidate combines
hands-on pharmaceutical manufacturing experience with
capital project execution expertise, capable of supporting process improvements, equipment upgrades, facility modifications, technology transfers, and strategic engineering initiatives while maintaining Lilly's high standards for safety, quality, and operational excellence.
