Parenteral Process Engineer

7 giorni fa

Sesto Fiorentino, Italia Lilly A tempo pieno

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. The scope can include technical transfer of newly launched products, products in the process of launching, but also products already approved that can require additional capacity.

A key part of this role is ensuring that there is consistency in approach and processes, up through and including first submissions and approval.

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 to ensure 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 Technologies
  • provide consulting support on technical issues for DPEM parenteral sites
  • work effectively with partner companies and contract manufacturers as needed
  • assist CMOs with technical evaluation, and specific problem resolution including troubleshooting and root cause analysis
  • provide technical consulting to CMOs as required
  • DPEM Parenteral Process Engineer collaborates with the Project Managers as well as 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 deliverables
  • serve 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 Teams.
  • understand the scientific principles required for manufacturing DPs, including the interaction of the chemistry, equipment, aseptic processes, container closure systems.
  • ensure 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:
  • partner with DPEM joint process team to build and execute the handover plan for commercial manufacturing.
  • aseptic operations (such as line setup, interventions/operations, etc.)
  • engineering batch manufacturing, Demo and PV batches manufacturing as well
  • preparing, reviewing and approving all relevant technical documents, such as change controls, Tech Transfer Plans, PFMEA, risk/gap assessments, as required
  • the execution of activities (such as technical and engineering studies, demo batch protocols) to enable batch manufacture and tech transfer activities of drug products
  • technical investigations and CAPAs, as needed
  • Gate reviews, Manufacturability Reviews (MRs), and other technical meetings as required

Relationships:

  • 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 functionally
  • Strong problem-solving
  • Ability to work across boundaries (functional, geographic, external company, etc.).

Minimum Requirements:

  • 2+ years in cGMP manufacturing or manufacturing support experience
  • Demonstrated ability to solve technical problems and implement projects
  • Good of parenteral processing equipment and operations
  • Good interpersonal and communication skills to be effective in a team-based situation
  • Ability to work across boundaries (functional, geographic, external company, etc.)

Other Information:

  • Must be able to travel up to 30% of the time
  • Good PC skills; good verbal and written communication skills
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