Job Information
Lilly Pharmaceutical Manufacturing Process Engineer in Indianapolis, Indiana
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.
Organization Overview:
CT Parenteral Operations consists of a vial filling operation and a flex filling operation that both support early phase clinical trials. This process engineer position will support CT Parenteral Manufacturing in B358. This position will report to the CT Parenteral Ops Process Engineering Lead.
Responsibilities:
The Process Engineer will provide technical and engineering support during the definition of process and equipment systems requirements, development of systems design and procurement packages, equipment and systems fabrication, installation, startup, testing, commissioning and qualification (C&Q) of the CT parenteral facility project with the goal to own part of the processes and equipment after project delivery completion. Provide technical oversight and ownership for assigned aseptic processes equipment systems which could include GMP process utilities, dispensing and formulation, parts washer and autoclave, filling, freeze drying, inspection and/or final packing into shippable containers.
During the whole process and after delivering the process within the facility the process engineer will effectively partner with both internal and external partners to achieve established goals and desired results.
Provide design and delivery expertise for Process Systems in the B358 CT Parenteral Manufacturing
Assure that project process designs/installations are safe, operable, maintainable, economical, and compliant with regulatory requirements and authorized project scope.
Participate in or lead the startup, C&Q activities through Planning, Reviews, Approvals, Execution and/or consultation on activities as needed
Participate in Cycle Development and PQ activities through Planning, Reviews, Approvals, Execution and/or consultation on activities as needed.
Technical oversight of the parenteral manufacturing operations
Provide technical and process engineering oversight for filling equipment and auxiliary systems, and support operations from an equipment performance sustainability, capability, reliability, safety, and compliance process flow perspective. Maintain current and accurate as-built equipment drawings and records (P&ID’s, layouts, flows and specifications).
Ensure a safe working environment by following safety rules and helping implement/improve the safety culture.
Review and support approval of processing tickets and batch records to ensure processes are within qualified ranges and capability of the equipment, incorporating all cGMP aspects
Respond to and implement customer requests related to equipment performance, breakdowns, and improvements.
Coach and mentor peers in the process engineering team, as well as others in the B358 CT Par Ops Org.
Support peer review documentation of learning points, technical studies and investigations
Capture and share lessons learned. Develop and/or support the capture of key process knowledge.
As Process Equipment and Systems Owner, ensure systems perform in a reliable and efficient manner, and remain in a qualified state and are appropriate to use.
Schedule and support shutdown maintenance activities with multi-discipline resources.
As System Owner for assigned process equipment, oversee the timely execution of Periodic Qualification Evaluation (PQE) and closure of identified issues.
Analyze historical data to identify potential areas for improvement, as well as identify changes or shifts in the processes.
Participate in or lead Process Failure Mode and Effect Analysis (pFMEA) and Process Hazard Reviews as necessary. Provide support or lead the implementation of recommendations from equipment and operational failures investigation, pFMEA, Process Hazard Reviews and other safety and quality audit findings
Utilize change management system to create, review, approve, execute, close changes and associated action items. Ensure changes (direct and indirect systems) are made in accordance with applicable Lilly standards.
Utilize incident management system to support or lead to create, document, close investigations and associated action items.
Basic Requirements:
BS in Engineering such as Chemical, Mechanical, Industrial, or equivalent.
The applicant's R-level (R2 to R4) is commensurate with relevant skills and experience, with a minimum of 3 years required
Depending on R-level, exceptional project management, planning, coordination, leading multi-discipline cross functional teams, effective follow up written and verbal, and organizational skills with attention to detail.
Strong troubleshooting and problem-solving skills with the ability to identify key issues in manufacturing process equipment and systems and lead a team to the appropriate solution(s) for complex problems.
Excellent verbal and written communications skills with the ability to interact well in a team environment.
Additional Skills/Preferences:
Parenteral Manufacturing experience. (Decontamination, Sterilization, Cleaning, Environmental Monitoring, Particulate Control)
Experience with equipment C&Q and validation activities preferred
Familiarity with Six Sigma or similar process improvement methodologies
Familiarity with Trackwise1000
Familiarity with GMARS / Maximo or similar maintenance management systems
Other Information:
Monday through Friday Day Shift
There will be some off-hours support.
Location: LTC-North, B358
Travel: < 10%
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 ( https://careers.lilly.com/us/en/workplace-accommodation ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
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. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$76,500 - $167,200
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.
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