Sr. 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.

Main Purpose and Objectives
Provides technical expertise and leadership to dry product operations (DPO), commercialization activities and site projects ensuring compliance with cGMPs, HSE guidelines and regulations, company standards and business practices. The primary areas of technical support include technical advice and leadership, design verification lead for new and/or renovated capital assets, manufacturing and business process improvements, compliance with business systems, and people development.
 

Responsibilities
1-    Technical Advice to DPO Manufacturing activities

• Coach and mentor process engineers in aspects of fundamental engineering principles, including process understanding (both theoretical and practical), process capabilities/capacity, problem solving, engineering design, and project management.
• Provide coaching and direction on technical matters to Technical, Operations, and Compliance personnel.
• Stay abreast of the latest technology trends, applications, and Compliance requirements.
• Oversee process and equipment performance in areas under responsibility and assure they adhere to Business and Compliance requirements.
• Identify and lead efforts to improve processes and operations in alignment with Company goals.
• Serve as technical expert in support of other teams and departments (TS/MS, Maintenance, Engineering, Quality, etc.).
• Identify training and development needs of technical resources (including self and others) and lead efforts to create opportunities for knowledge sharing (coordinating external/internal trainings, leading technical forums for knowledge transfer and sharing, etc.).
• Support and Lead Process Improvement initiatives within the DPO (C4I, Six Sigma, Lean Manufacturing, Root Cause Analysis, SPC, FMEA, etc.).
• Can be assigned as System owners for the following: Process Safety Management (PSM) elements: PHR, PSI, Management of Change and/or PSSR.

2-    Design Verification Lead (New and/or Renovated Capital Assets)

• Assists in the development of standard operating procedures and best practices related to design/verification and ensure they remain current with industry best practices.
• Coordinates all design for the Project Manager during the design phases of the project and is responsible for delivering the conceptual design review and basic design review.
• Expedites design decisions and information flow between the design team and system owners.
• Responsible for ensuring the design meets approved intent through interactions between the design firm, design specialists, engineering tech center disciplines, and end user/customer.
• Responsible for design activities and governance (both within Lilly and contractors), timely resolving issues.
• Works with Engineering Tech Center resources and other key project team technical/constructability resources to address and resolve design issues.
• Responsible for the application of the appropriate Engineering Design Standards, Engineering Functional Standards, Engineering Specifications and Regulatory requirements.
• Responsible for the overall design quality.
• Reviews design-related invoices prior to approval and participate in KPI reviews/assessments.
• Accountable for the development of the Project Verification Plan, Traceability Matrix, and risk assessments (not necessary lead the execution).

3-    Technical Leadership (Process and Equipment, including applicable GIPSM elements – e.g. Dust Explosion)

• Provide DPO technical expertise to lead/assist in the design and operation of efficient manufacturing processes.
• Be the equipment expert and asset steward to DPO in general.
• Provide support to the management of daily operations, including 24hr/7days technical support (call in assistance if necessary).
• Alternate attendance on different DPO Process Team/Production morning meetings.
• Develop and monitor control systems for process indicators to identify and address performance issues.
• Perform troubleshooting and investigation on complex unexpected issues resulting in manufacturing interruptions or delays. Coach less experienced Engineers in Process Teams.
• Lead/own Equipment related Deviations, CAPAs and Changes.
• Provide technical expertise for installation, operation, maintenance, and reliability of process equipment.
• Serve as liaison between maintenance, reliability, utilities, and automation and DPO in general.
• Own the qualified state of their equipment and perform AQM according to the defined strategy. Site Lead of the AQM process.
• Oversee/lead/own Commissioning & Qualification (C&Q) strategies and execution for assets. Provide coaching to Process Engineers, Process Team and Project Team members.
• 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.
• Collaborate with Maintenance personnel to get maintenance plans established for equipment.
• Assure safety processes (procedures, training, and equipment) are in place (i.e., LOTO, Line breaking, etc.).
   

4-    Manufacturing and Business Process Improvements

• Be responsible (as it relates to equipment) for process capacity definition/understanding, monitoring, and identifying control/improvement opportunities. 
• Lead efforts in design and installation of new equipment (Develop scope of work for capital projects, provide options for consideration, provide DPO technical expertise during capital project design/equipment installation/validation, support development and execution of cleaning protocols with QA and Technical Services).
• Lead functional groups in development/implementation of changes for equipment/floor operations.
• Lead project improvements for capacity, product quality, materials consumption, waste/emissions generation, safety and process variability.
• Lead problem solving activities including root cause analysis, FMEA, problem analysis and countermeasure development and implementation.
• Perform and summarize improvement opportunities in technical reports, investigations, plant/lab trials, data analysis and process modeling.
• Understand equipment/process capacity constraints and identify solutions/improvements.

5-    Compliance with Business Systems 

• Lead & support event investigations (i.e., Quality, Safety & Environmental).
• Lead and support implementation of action plans resulting from event investigations and trend analysis.
• Lead and support development and implementation of changes. (i.e., Quality, Safety & Environmental).
• Oversee/Ensure compliance with all regulatory agencies (Health and Safety & Environmental, FDA, etc.).
• Comply with Process Safety Management, Environmental, and Health and Safety programs. 
• Communicate/escalate any non-conformance with permits or processes and establish action plans to correct.

6-    People Development

• Develop and/or provide technical training on DPO process equipment requirements.
• Develop specialized technology/unit operations knowledge.
• Transfer knowledge of equipment/process capabilities to operations and support groups.
• Benchmark with suppliers and other companies, share benchmark information, and implement.

Basic Requirements:

• BS in Engineering (Chemical or Mechanical preferred)
• Minimum of eight (8) years of experience in pharmaceutical manufacturing industry. Demonstrated technical knowledge in Process Equipment requirements, operations, cGMP and Safety specifically those related to Dry Product operations.
• At least five (5) years of experience in engineering and/or technical service roles providing technical support to the organization.
• EIT license minimum (member of CIAPR)
   

Additional Preferences:

• Strong leadership, organizational and project management skills
• Ability to effectively facilitate conflict to resolution.
• Effective meeting management
• Ability to influence all levels of the project and site personnel.
• Able to concisely communicate complex options to a cross functional/multi-company team to gain consensus on design direction.
• Excellent problem-solving skills with the ability to envision and deliver innovative solutions.
• Strong customer service focus, compliance mindset and sound judgement
   

Additional Information:
•    Support a 24/7 operation, if necessary
•    Availability to travel within and outside Puerto Rico and U.S.
 

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.

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