Process Engineer 2

Merck•Indianapolis, IN

46d•Onsite

About The Position

In this role you will be responsible for executing business unit driven process development programs using practical application of fundamental engineering principles in a cGMP setting associated with sterile injectable products. Responsible for providing key engineering/technical support and project coordination. Responsible for interfacing with internal and external clients in support of product technology transfer, manufacture and investigations. Tech Support efforts primarily focus on process engineering, scale-up and continued support for complex formulations such as PEGylated formulations as well as Liposomal and Lipid Nanoparticles (LNP) based formulations. Importantly, this specific role will help facilitate the transfer and introduction of new chemical processes from the development lab or directly from the client through to full-scale manufacture as well as technical support for the improvement and optimization of chemical processes.

Requirements

Bachelor’s Degree in Chemical Engineering, Biochemical Engineering, or other Engineering discipline.
2+ years of engineering experience within a pharmaceutical company.

Nice To Haves

Experience with US and European GMP requirements, FDA guidelines, and industry validation expectations.
Strong critical thinking, multi-tasking, & technical skills.
Prior experience with Lipid Nanoparticles, Liposomes, PEGylated formulations, Lyophilization unit operations and/or other nanomedicinal parenteral products.
Experience with spreadsheets, word processing, databases, and Microsoft Project.
Experience with Root Cause Analysis methodology.
Experience with Microsoft Visio, AutoCAD, or similar drawing program.
Experience with Minitab, Jump, or similar statistical software.

Responsibilities

Provide technical support for the manufacturing processes, including process investigations, continuous process improvements, technology transfer and scale up of new product introductions.
Leverage process knowledge/experiences to become a subject matter expert (SME) for multiple product lines (preclinical through commercial).
Coordinate and execute small to medium scale and/or complex technical projects.
Associated functions include process and equipment design engineering, project estimating and budgeting, developing capital appropriation requests, documentation updates, scheduling and overall project coordination and oversight.
Project staffing will be comprised of personnel from various departments on-site, as well as contract personnel.
Coordinate and execute tech transfer projects in support of new clinical and commercial products and contract manufacturing opportunities.
In addition to project management responsibilities described above, will be the main technical interface with external / internal clients and contractors in support of contract manufacturing opportunities.
Provide project and process engineering support for technical projects.
Associated tasks include equipment specification and procurement, process development, drawing development, protocol development and execution.
Interpret, modify and create engineering drawings, including Piping and Instrumentation Diagrams, Piping Drawings, Layouts, Isometrics, Building Mechanical, Instrumentation and Electrical Drawings.
Creation of Standard Operating Procedures (SOPs) for new equipment/processes, as well as update of existing SOPs.
Perform process and utility calculations as related to hydraulic design, heat transfer, material balances, etc.
Lead and provide technical support for process investigations.