Associate - Operations Support

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. Lilly is currently constructing a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland. This facility will be Lilly’s most technically advanced manufacturing site and will include next-generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. To facilitate bringing the plant on-line, several operational support roles will be necessary to plan all the activities to start-up the facility, facilitate creation of multiple business processes, conduct Performance Qualification, complete Process Validation, then assume day to day production activities. The Operations Support Associate will be responsible for working closely with Operations Process Teams, Functional support personnel (Engineering, Technical Services/Manufacturing Sciences, IDS), Project Leads, and others to provide technical and operational support. The ideal candidate may be proficient in several of the tasks below, but not all. Key Objectives/Deliverables:

Operations Support:

• Ensure all activities are conducted following all HSE and GMP requirements.
• Work closely with the Leadership to coordinate necessary resources to support activities throughout the duration of the start-up.
• Escalate issues to the appropriate management level when necessary.
• Work with functional leadership to organize, prioritize, and deliver on start-up initiatives to adhere to project milestones.
• Establish framework for operations activities.
• Write procedures so that all operations activities are consistently executed.
• Serve as an integrator to ensure all necessary activities in each phase of start-up are well planned and executed.
• Participate in or lead efforts associated with the Training Quality system to help define the overarching training strategy.
• Participate in or lead the design, development, and implementation of Biotech operations training through multiple waves of new hires and multiple phases of the project.
• Participate in or lead the content creation and delivery of training materials through multiple waves of new hires and multiple phases of the project.
• Assist with on-boarding operations staff throughout the duration of the project.
• Work with Supply Chain personnel and Logistics Center to develop business process associated with Planning and Scheduling operations activities throughout the duration of the plant start-up.
• Participate in or lead efforts to design and generate facility/process procedures and work instructions, electronic Batch Records, Logbooks, various training documentation, all start-up protocols (C&Q, PQ, PV, etc).
• Liaising with vendors for equipment, services, and consumables to ensure all necessary equipment and vendors are appropriately qualified for the various phases of the project execution.
• Support protocol executions throughout all phases of the project.

Basic Requirements:

• Minimum 3 years of biotech manufacturing-related experience, preferably some biosynthetic, fermentation, and/or purification operations experience.
• Demonstrated skills in project management and coordination.
• Ability to communicate effectively to various audiences.
• Ability to influence and network with multiple levels and functions of the organization.
• Proficient in MS Office applications and training database administration.
• Familiarity with cGMPs and corporate policies and procedures.
• Strong written and verbal communication skills.
• Strong organizational skills – ability to handle/prioritise multiple projects and requests.
• Able to manage linked activities with rapid flow of integrated information.
• Strong sense of customer focus and teamwork. (Ability to deal with unexpected issues in a constructive and collaborative way).
• Ability to work independently and without direct supervision.

Additional Preferences:

• Language: English
• Familiarity or expertise in SAP
• Biotech Operations Experience
• GMP Operations Experience

Education Requirements: Third Level Qualification or equivalent education / relevant experience. Other Information:

• No certifications required.
• Tasks require entering manufacturing areas which require wearing appropriate PPE.

The job specification is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job specification. As always, you should consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position. #J-18808-Ljbffr