Associate - Operation Parenteral Filling

Lilly • Concord, NC

7d • $65,250 - $160,600

About The Position

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.
Company Overview
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Overview
Lilly is investing over $1 Billion to build a completely new, inspiring, and highly automated campus in Concord, North Carolina which will house warehousing & logistics, parenteral operations, medical device assembly, and packaging, QC laboratories, and support teams to produce medicines for an unmet patient need.
If you ever wanted to have a direct impact on building a team’s culture and on how the team operates, now is the perfect opportunity!
Responsibilities
During the project phase, the Operations Associate (OA) will support commissioning, qualification, and validation of the Parenteral (PAR) areas as well as lead / assist in operations readiness programs (e.g. Material procurement and definition, training programs, operational excellence programs, establishing standard work programs, continuous improvement, and capacity planning). The PAR department will have ownership of product formulation, aseptic isolator barrier filling, and visual inspection operations. The person in this role will be the PAR area’s technical subject matter expert and will be involved in hiring and training personnel. This position will require travel domestically with the opportunity for travel internationally to collaborate and learn from sites that produce our medicines currently.
Once the facility is turned over to operations, the OA role is responsible for daily performance management and support of the PAR process team. This individual must ensure cross functional collaboration between operations, engineering, quality, supply chain and maintenance to meet key metrics and deliverables for the area. Above all else, the role will lead by example with a safety first, quality always approach.
As a site leader and expert at our growing site, you will have significant opportunities for growth into future leadership and technical roles.

Requirements

• Bachelor's degree in a STEM or pharmaceutical related field of study.
• At least 2 years working within manufacturing/operations.
• Understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA, or other similar groups
• Excellence in; electronic, written, and oral communication skills
• Strong technical aptitude as demonstrated through previous work or educational accomplishments
• 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.
• Ability to work and gown in a cleanroom (Grade C, ISO 8) environment.
• Position will involve frequent business trips domestically with potential international travel to support testing of equipment at vendor sites, visit Lilly sites to learn and collaborate, and to build global network.
• Travel domestically and internationally, up to approximately 20% of the year to learn and network with colleagues.

Nice To Haves

• Working within or directly supporting pharmaceutical, food, packaging, or applicable manufacturing departments
• Highly automated equipment (inspection, filling, device assembly, packaging, etc.)
• Digital operations programs
• Aseptic filling, single use assemblies, isolator technology.
• Automated, semi-automated, and/or manual inspection.
• Advanced computational capabilities (e.g. Data Analysis, Pareto and Control charting, Trending and computing with multiple variables)
• Technical writing such as creation of standard operating procedures, work instructions, and training documentation.
• Facility, Equipment, Systems Start-up
• Equipment design, qualification, and process validation.
• 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)

Responsibilities

• Lead by example with a Safety first, Quality Always mindset. 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 as a lead investigator 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.
• Lead and facilitate operations readiness activities and programs for the PAR portion of the business which include consumable and supplies definition and procurement, training resource development, GMP documentation creation, and management of people, materials, product flows throughout the facility
• 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
• Develop, monitor, and propose solutions to improve or meet key performance indicators (KPI) for the area.
• Support Site Leadership to build a diverse and capable site organization while delivering area operational procedures, quality processes and controls for the Parenteral manufacturing area.
• Lead area tours to support business reviews, regulatory audits, or network collaboration.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees