Eli Lilly and Company · 4 hours ago
Associate Director - Engineering - Packaging Operations
Eli Lilly and Company is a global healthcare leader headquartered in Indianapolis, Indiana, dedicated to improving lives through innovative medicines. The Engineering Associate Director for Packaging Operations will lead the engineering group in supporting the expansion of a new manufacturing site, focusing on staffing, training, and day-to-day engineering activities post-startup.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Manage Engineering and Maintenance support for Commercial Manufacturing Operations:
Manage team of process and automation engineers and maintenance technicians providing Front Line support in one or more of the following areas:
Parenteral Operations (Parts Washers, Autoclaves, Formulation, Isolator – Syringe Filler, Automated Visual Inspection)
Device Assembly
Packaging Operations
Warehouse and Logistics (Autonomous Guided Vehicles, Automatic Storage and Retrieval System, etc.)
Site Utilities (HVAC, Steam Water, Gases, etc.), BMS, Chambers (i.e. Refrigerators, Incubators, Cold Rooms, etc.)
Ensure appropriate technical and maintenance support for manufacturing or utilities processes of the assigned area
Guide SMEs that will provide coaching/assistance to Front Line Engineers and drive increased equipment reliability and uptime, continuous improvements, support capital delivery, among other key strategic initiatives
Understand, ensure and decision making based on engineering standards and policies, procedures and business plan that impact the ability of the team members to meet performance objectives
Provide Functional Leadership to engineering and maintenance representatives by coaching the following business processes: Change Management, Deviations/Investigations, Equipment and Process Improvements, Process Controls and Variability Reduction
Lead, support and peer review root cause analysis around equipment and operational events, support complex change controls and quality investigations with strong Root Cause analysis focus
Prioritize teams work to optimize equipment output and impact, ensuring proactive and continuous improvement mindset for process and operational improvements and optimization
Apply statistical thinking and data analysis methods to understand process variability and capability to drive improvement
Support regulatory inspections
Utilize control systems to monitor, trend and verify equipment performance and downtime. Identify and Optimize unit operation cycle time, yield performance, loop tuning, recipes, etc
Support or lead troubleshooting efforts to resolve equipment and operational problems and ensure formal problem-solving techniques are appropriately utilized. On call/off hours support required
Understand and ensure compliance with environment health & safety requirements
Present and attend various Governance teams to represent engineering
Represent group as technical SMEs on capital projects supporting/leading design, modifications, testing, qualifications, and associated documentation
Support commissioning and qualification activities
Provide leadership, training, development, coaching and support of engineering team members
Engage and promote use of internal and external networks and partnerships to help deliver sound technical decisions
Promote use of first principals with engineering staff, and drive engineering solutions for problems
Monitor and ensure compliance with quality requirements. (trainings, CAPA, deviations)
Qualification
Required
Bachelor's degree in engineering
At least 7 years process engineering experience
Preferred
Previous management or leadership experience including leading or working effectively with a cross functional group
Strong experience in equipment optimization, reliability and troubleshooting
Strong technical aptitude and ability to train and mentor others
Solid understanding of basic requirements of regulatory agencies such as the FDA, EMEA, DEKRA, and OSHA
Previous experience with highly automated equipment
Previous experience with combination products, device assembly, pharmaceutical packaging, drug product formulation and filling in aseptic environment
Previous facility or area start up experience
Previous equipment qualification and process validation experience
Previous experience with Manufacturing Execution Systems and electronic batch release
Previous experience with Automated Storage and Retrieval System (ASRS) Warehouses or AGVs
Previous experience with deviation and change management systems including Trackwise
Benefits
Company bonus
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
Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)
Company
Eli Lilly and Company
We're a medicine company turning science into healing to make life better for people around the world.
H1B Sponsorship
Eli Lilly and Company has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (514)
2024 (236)
2023 (167)
2022 (133)
2021 (57)
2020 (52)
Funding
Current Stage
Public CompanyTotal Funding
$6.5M2024-02-12Post Ipo Debt· $6.5M
1978-01-13IPO
Leadership Team
Recent News
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