Parenteral Process Engineer - Drug Products External Manufacturing Re

Parenteral Process Engineer - Drug Products External Manufacturing
Re
Piemonte, Re

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 The Parenteral Process Engineer of Drug Products External Manufacturing (DPEM) is responsible for providing engineering technical support to commercialization activities within DPEM. DPEM is responsible for the commercialization of drug products (DPs) at selected contract manufacturers (CMs) located globally, but also is responsible for technology transfers of Drug Products that have been already approved.

The scope of the role includes all parenteral assets, including technical transfer of newly launched products, products in the process of launching, and products already approved that may require additional capacity. A key part of this role is ensuring consistency in approach and processes, up through and including first submissions and approval.

The DPEM Parenteral Process Engineer can be involved with clinical trials and supports all the commercialization activities up to first submissions and approval of the DP by providing technical support to ensure processes are in alignment with Manufacturing Standards of Operational Excellence (MSOE), Lilly Global Quality Standards (GQS), Lilly Quality Standards (LQS), and DPEM commercialization procedures.

The DPEM Parenteral Process Principal Engineer is also responsible for providing technical oversight of DPEM team members and ensuring the appropriate handover to commercial manufacturing.

Key Objectives/Deliverables:

DPEM Parenteral Process Engineer provides technical support as follows:serve as a technical resource in Aseptic Processing and Parenteral Technologiesprovide consulting support on technical issues for DPEM parenteral siteswork effectively with partner companies and contract manufacturers as neededassist CMOs with technical evaluation and specific problem resolution including troubleshooting and root cause analysisprovide technical consulting to CMOs as requiredDPEM Parenteral Process Engineer collaborates with the Project Managers and the cross-functional tech transfer team members and Chemistry, Manufacturing and Controls (CMC) development team for transferring new and existing products into CMs as follows:support issuing technical transfer and commercialization deliverablesserve as technical interface with CMC development team, Lilly Molecule and Component/Container Closure Systems Stewards, Central TSMS Commercialization, DPEM Tech Lead, and DPEM Joint Process Teamsunderstand the scientific principles required for manufacturing DPs, including the interaction of the chemistry, equipment, aseptic processes, and container closure systemsensure the technical transfer of robust processes and establish appropriate critical and operational process parameters, in-process controls, and studies such as filling profile, dose accuracy, plungering/stoppering/sealing adjustments, spallation, etc. provide technical support for:partnering with the DPEM joint process team to build and execute the handover plan for commercial manufacturingaseptic operations (such as line setup, interventions/operations, etc. )engineering batch manufacturing, Demo, and PV batches manufacturingpreparing, reviewing, and approving all relevant technical documents, such as change controls, Tech Transfer Plans, PFMEA, risk/gap assessments, as requiredthe execution of activities (such as technical and engineering studies, demo batch protocols) to enable batch manufacture and tech transfer activities of drug productstechnical investigations and CAPAs, as neededGate reviews, Manufacturability Reviews (MRs), and other technical meetings as requiredRelationships: Contract Manufacturing functions. All relevant functions at the Lilly Manufacturing Networks (such as M&Q central functions, and Regulatory Affairs) and at Lilly Product Development. DPEM and Lilly External Manufacturing teams. Basic Qualifications Education:Bachelor's Degree or higher in science or science-related field such as Engineering or related Life Sciences. Experience:Experience with parenteral DP manufacturing technologies/processes. Experience with qualification of DP manufacturing equipment, utility, and facility. Additional Skills/Preferences Demonstrated ability of collaboration to operate cross-functionallyStrong problem-solvingAbility to work across boundaries (functional, geographic, external company, etc. ). Minimum Requirements: 2+ years in cGMP manufacturing or manufacturing support experienceDemonstrated ability to solve technical problems and implement projectsGood understanding of parenteral processing equipment and operationsGood interpersonal and communication skills to be effective in a team-based situationAbility to work across boundaries (functional, geographic, external company, etc. )Other Information: Must be able to travel up to 30% of the timeGood PC skills; good verbal and written communication skillsLilly 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 does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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