Lilly Medicine Foundry
healthcare
LeadOperator,Operations
Neural analysis suggests this role is
optimal for Lead candidates.
“Lead Operator, Operations at Lilly Medicine Foundry. Skills: process management, cross-functional coordination, vendor/stakeholder management, operational metrics, resource planning, continuous improvement, leadership, troubleshooting, cGMP, safety. supports start-up activities to bring manufacturing equipment into service. becomes an expert in their assigned area and educates the team on the proper operation of the facility”
What You'll Achieve.
meet production plans; meet production schedule
Industry & Context.
troubleshooting and reaction to process upsets; Flexibility to troubleshoot and triage challenges effectively
domestic and international travel, work a 12-hour rotating shift, May be required to provide support outside of normal working hours including nights, weekends, and holidays
What They're Looking For.
Must Have
HS Diploma/GED, 3+ years of directly applicable manufacturing experience, 2 years of direct leadership/supervisory experience required, API experienced required, Qualified applicants must be authorized to work in the United States on a full-time basis
Nice to Have
GMP and/or chemical processing strongly preferred, Previous experience in facility or area start-up environments, Previous experience in a pharmaceutical or chemical manufacturing operation involving PSM-regulated or hazardous chemicals, A solid understanding of FDA guidelines and cGMP requirements, organizational skills with the ability to handle and prioritize multiple requests, Knowledge of lean manufacturing principles, Flexibility to troubleshoot and triage challenges effectively, The ability to understand technical nomenclature and language, as well as work with mathematical formulas
What You'll Do.
supports start-up activities to bring manufacturing equipment into service
becomes an expert in their assigned area and educates the team on the proper operation of the facility
provides on-the-floor
tactical leadership for production of API molecules
ensures a safety-first
quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills
ensures the supply of our medicines by supporting the team
following instructions
assisting with troubleshooting
collaborating cross-functionally
and upholding our safety-first
quality-always mindset
support daily activities to meet production plans
enforce adherence to compliance requirements (safety
and environmental) and appropriately escalating any adverse events
Operating processes and equipment according to batch records
standard operating procedures
and work instructions to meet production schedule
Provide on-the-floor leadership to make tactical day-to-day decisions and ensure proper prioritization of operations resources throughout the shift
Ensure completion of daily monitoring
and cleaning duties to ensure equipment and systems are in good operating condition and maintained per local and corporate regulatory requirements
Serve as a cultural leader for site safety culture
promoting compliant operations and positive safety behaviors
Provide technical leadership for troubleshooting and reaction to process upsets
integrating operator input and escalating as appropriate
Follow all applicable procedures for safety event reporting and documentation
Ensure adequate communication at shift passovers and participate in daily shift huddles/meetings to understand and set expectations for daily operational goals
Ensure all area personnel follow cGMP practices
and housekeeping requirements unique to the work area and job classification
Partner with area management and supervision to understand Foundry strategy and future production needs
Actively participating in assigned building and area operations such as safety audits
procedure coordination
and continuous improvement projects
Using specified company-supplied personal protective equipment (PPE) as required
How You'll Work.
Team & Collaboration
educates the team on the proper operation of the facility; collaborate, train, and learn from sites that currently produce APIs; collaborating cross-functionally; Provide on-the-floor leadership to make tactical day-to-day decisions and ensure proper prioritization of operations resources throughout the shift; Ensure adequate communication at shift passovers and participate in daily shift huddles/meetings to understand and set expectations for daily operational goals; Partner with area management and supervision to understand Foundry strategy and future production needs; Represent and support this strategy in conversations with shift members
Communication Scope
Ability to effectively communicate (electronically, written and verbal)
Process & Methodology
continuous improvement projects
Full Job Description
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. **Job Position Overview:** The Lilly Medicine Foundry Manufacturing Lead Operator actively supports start-up activities to bring manufacturing equipment into service. The Lead Operator becomes an expert in their assigned area and educates the team on the proper operation of the facility. This role requires domestic and international travel to collaborate, train, and learn from sites that currently produce APIs. Upon completion of the project phase, the Lead Operator provides on-the-floor, tactical leadership for production of API molecules. The Lead Operator ensures a safety-first, quality-always approach while managing a production process that encompasses diverse unit operations and manufacturing skills. **Responsibilities:** This role ensures the supply of our medicines by supporting the team, following instructions, assisting with troubleshooting, collaborating cross-functionally, and upholding our safety-first, quality-always mindset. Lead Operators will support daily activities to meet production plans by: * Responsible to help enforce adherence to compliance requirements (safety, quality, and environmental) and appropriately escalating any adverse events. * Operating processes and equipment according to batch records, user manuals, design parameters, standard operating procedures, and work instructions to meet production schedule. * Provide on-the-floor leadership to make tactical day-to-day decisions and ensure proper
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