Associate Director - Device, Assembly, and Packaging
Wisconsin Staffing, Pleasant Prairie, Wisconsin, United States, 53158
Lilly Operations Associate Director
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. Responsibilities:
During the project phase, the Associate Director (AD), Operations is responsible for staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start up, and validation of the parenteral operations (PAR) OR device, assembly, and packaging (DAP) areas. Once the facility is turned over to operations, the AD role is responsible for ensuring the group meets annual production goals as well as planning through 13-year horizons. The AD will be responsible for leading their respective cross-functional process teams. Direct line supervision for this role includes Supervisors and Operations Associates. Key Objectives/Deliverables:
Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation. Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups. Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions. Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations. Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve. Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE). Understand and influence the manufacturing control strategy for their area. Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral/DAP manufacturing area. Responsible for a work force of approximately 40
70 individuals on various shifts, with multiple shift supervisors and associates reporting directly to them. Provide leadership and develop objectives to deliver Business Plan goals as it relates to production volumes, finances, safety, quality, stewardship, and people. Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety. Leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support. Represent their Operations Process Team on the Plant Flow (value stream) Team. Basic Qualifications:
Bachelor's degree in a STEM or pharmaceutical related field of study. At least 7 years working in the pharmaceutical industry. Previous management or leadership experience including leading or working effectively with a cross functional group. Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA. Excellence in; interpersonal, electronic, written, and oral communication. Strong technical aptitude and ability to train and mentor others. Additional Skills/Preferences:
6+ years in manufacturing/operations with 4+ years in supervisory role cGMP standards and FDA (or other industry) guidelines for production Highly automated equipment (inspection, packaging, filling, assembly, etc.) Creation of standard operating procedures, work instructions, and training documentation. Equipment & Facility design documentation reviews Facility, equipment, or system start up. Qualification and process validation experience. Manufacturing Execution Systems and electronic batch release. Automated Storage and Retrieval System (ASRS) Warehouses or AGVs. Continuous improvement methodologies and mindset
lean, six sigma, etc. Documentation, deviation and change management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat) Additional Information:
Ability to wear safety equipment (glasses, shoes, gloves, etc.) Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.
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. Responsibilities:
During the project phase, the Associate Director (AD), Operations is responsible for staffing, training, and leadership of the operations group supporting asset delivery, process development, operations readiness, start up, and validation of the parenteral operations (PAR) OR device, assembly, and packaging (DAP) areas. Once the facility is turned over to operations, the AD role is responsible for ensuring the group meets annual production goals as well as planning through 13-year horizons. The AD will be responsible for leading their respective cross-functional process teams. Direct line supervision for this role includes Supervisors and Operations Associates. Key Objectives/Deliverables:
Comfortable with exercising and encouraging "Stop Work Authority" for all employees if there is a perceived unsafe or product impacting situation. Lead/conduct area deviation and corrective action discussions with a cross-functional team from Engineering, Maintenance, Technical Services / Manufacturing Sciences (TS/MS), Quality, and Health, Safety, and Environmental (HSE) functional groups. Present operations investigations and procedures to Regulatory Agencies and act as a Subject Matter Expert (SME) for related inspections, tours, and discussions. Ensure consistency of operations across shifts through active engagement on the shop floor, Gemba walks, and Practice vs. Procedure evaluations. Maintain and communicate metrics to measure performance against business objectives and make necessary changes to continuously improve. Participate in the development and implementation of strategies focused on the following initiatives: Continuous Improvement, Root Cause Analysis (RCA), Failure Modes Effect Analysis (FMEA), Operational Standards for Supply Chain Excellence (OSSCE). Understand and influence the manufacturing control strategy for their area. Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral/DAP manufacturing area. Responsible for a work force of approximately 40
70 individuals on various shifts, with multiple shift supervisors and associates reporting directly to them. Provide leadership and develop objectives to deliver Business Plan goals as it relates to production volumes, finances, safety, quality, stewardship, and people. Act as a primary contact for other areas such as Production Planning, HR, Quality Assurance, Engineering and Environmental/Safety. Leading the Operations Process Team, a cross functional group charged with making medicine, continuous improvement, and site support. Represent their Operations Process Team on the Plant Flow (value stream) Team. Basic Qualifications:
Bachelor's degree in a STEM or pharmaceutical related field of study. At least 7 years working in the pharmaceutical industry. Previous management or leadership experience including leading or working effectively with a cross functional group. Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and/or OSHA. Excellence in; interpersonal, electronic, written, and oral communication. Strong technical aptitude and ability to train and mentor others. Additional Skills/Preferences:
6+ years in manufacturing/operations with 4+ years in supervisory role cGMP standards and FDA (or other industry) guidelines for production Highly automated equipment (inspection, packaging, filling, assembly, etc.) Creation of standard operating procedures, work instructions, and training documentation. Equipment & Facility design documentation reviews Facility, equipment, or system start up. Qualification and process validation experience. Manufacturing Execution Systems and electronic batch release. Automated Storage and Retrieval System (ASRS) Warehouses or AGVs. Continuous improvement methodologies and mindset
lean, six sigma, etc. Documentation, deviation and change management systems (e.g., Trackwise. Veeva, QualityDocs, Kneat) Additional Information:
Ability to wear safety equipment (glasses, shoes, gloves, etc.) Ability to work 8 hours per day Monday through Friday with overtime as required to meet key objectives. Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees.