Senior Engineer - Site

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.

PURPOSE OF THE JOB:

The Site Engineer will provide oversight for LCCP’s facility management and serve as the site Subject Matter Expert (SME) for LCCP’s Facility, Utility, Maintenance and Equipment (FUME) with particular focus on the GMP pharmacy. He/she is responsible for commissioning, qualification and validation, as well as effectively, reliably and cost effectively operating and maintaining them in a state of compliance, in-control, and fit for use, capable of meeting all site needs. He/she will also drive continuous improvement initiatives and local capital investment.

COR JOB TASK

LCCP General Facility

• Oversee LCCP facility maintenance to ensure facility remains in good working condition.
• Oversee facility vendors contracted to provide facility management services.
• Work with Facility Associate to ensure facility compliance with relevant government regulations, industry regulatory requirements including Good Manufacturing Practice (GMP), Good Clinical Practice, Good Documentation Practice and internal Lilly policies and procedures.
• Participate in teams, committees, or other groups and/or individually to achieve the departmental, site and/or company goals as required.
• Support internal and external inspections and investigations (including Quality and HSE).

GMP Pharmacy

• Be the SME with a deep technical expertise in GMP Facility, Utility, Maintenance and Equipment (FUME) under his/her responsibility.
• Maintain FUME KPIs and monitor performance to ensure proper operation in compliance with requirements.
• Lead the development and implementation of efficient and effective maintenance and reliability techniques.
• Author, maintain and implement local FUME standard operating procedures.
• Manage FUME systems, including management of database, lifecycles, inventory, maintenance schedules, records and data files.
• Lead the development and implementation of Commissioning, Qualification and Validation (CQV) plans and protocols.
• Conduct routine review of CQV processes and documentation.
• Raise and manage FUME change requests according to the change management system.
• Lead investigation into FUME failures and deviations, demonstrating RCA lead investigator proficiency and implementing CAPA according to the deviation management system.
• Be capable of data mining, data analysis, process monitoring, and lead process control tuning parameters.
• Utilize statistical analysis tools to determine the process control, and capability for investigations.
• Engage and collaborate with internal and external stakeholders to provide consultation on FUME matters, ensure minimal impact on operational activities, and ensure timeliness of service delivery.
• Develop and conduct operations training of FUME systems as needed.
• Assist with process validations if required.
• Lead risk assessment exercises using the different tools available (e.g., FMEA).
• Identify risks and escalate situations with a sense of urgency.

REQUIRED QUALIFICATIONS AND EXPERIENCE

• Bachelor’s degree in Engineering (preferably Mechanical, Electrical or Chemical Engineering) with at least 7 years of relevant work experience.
• Engineering experience in the pharmaceutical industry and/or manufacturing plant utilities.
• Experience with equipment commissioning and maintenance.
• Experience with deviation and change management systems.
• Experience with project management (preferred).
• Previous start-up experience (preferred).

REQUIRED SKILLS

• Good interpersonal and communication skills.
• Good cGMP knowledge.
• Sound technical understanding of HVAC and utilities, with a high level of understanding of engineering concepts, 1st principles, and engineering functional standards.
• Office software skills (Word, Excel, PowerPoint, Outlook, data historian) and collaboration sites.

OTHER INFORMATION

• Able to work in a cleanroom environment.
• May be required to support work activities out of office hours.