Sr Process Engineer

The businesses of Merck KGaA, Darmstadt, Germany•Indianapolis, IN

10d•$112,000 - $168,000

About The Position

The Sr Process Engineer executes business-unit-driven process development programs using fundamental engineering principles in a cGMP setting for sterile injectable products. The role provides engineering and technical support, coordinates projects, oversees a team of engineers, and interfaces with internal and external clients on product technology transfer, manufacturing, and investigations. Technical support focuses on process engineering, scale-up, and ongoing support for complex formulations, including PEGylated formulations, liposomes, and lipid nanoparticles (LNPs). The engineer facilitates transfer and introduction of new chemical processes from development laboratories or clients through full-scale manufacturing, and supports improvement and optimization of chemical processes. The role may lead project teams comprising facility personnel and outside contractors, with responsibility for small- to medium-scale project budgets and support for facility projects, including clinical and commercial product technology transfers.

Requirements

Bachelor’s or master’s degree in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or a related field.
At least 5 years of experience in pharmaceutical operations as a validation engineer, process engineer, project engineer, or in a similar capacity.
Previous experience coordinating projects and personnel.
In-depth knowledge of U.S. and European GMP requirements, FDA guidelines, and industry validation expectations.
In-depth knowledge of aseptic manufacturing processes and packaging equipment, fill/finish operations, process unit operations, process control systems, computer systems, equipment cleaning, sterility assurance, process hazards, and safety.
Ability to work and make decisions independently and as part of a team, including in technically and mentally demanding situations.
Strong verbal and written communication skills.
Ability to coordinate multiple projects concurrently; strong mediation skills to gain and maintain cross-departmental project support.
Availability to work outside the standard operating shift on occasion as required to maintain the production schedule.
Sufficient mobility to work in a process environment and ability to climb stairs and ladders.

Nice To Haves

Prior experience with lipid nanoparticles, liposomes, PEGylated formulations, lyophilization unit operations, and/or other nanomedicinal parenteral products is strongly preferred.
Self-motivation, organization, conscientiousness, and effective interpersonal skills for working with clients and contractors.
Strong hands-on skills.
Advanced PC skills with spreadsheets, word processing, and databases.
Knowledge of Microsoft Project or similar project scheduling software; previous training in project management, Kepner-Tregoe, or another program.
Knowledge of Root Cause Analysis methodology, FMEA, or another program.
Knowledge of Microsoft Visio, AutoCAD, or similar drawing software, and Minitab, Jump, or similar statistical software.

Responsibilities

Provide technical support for manufacturing processes, including process investigations, continuous process improvements, technology transfer, and scale-up of new product introductions.
Develop subject-matter expertise across multiple product lines, from preclinical through commercial, particularly in nanomedicinal complex or conjugated formulations.
Mentor and lead a group of 1–5 engineers supporting process engineering, scale-up, technology transfer, and product investigations.
Coordinate and execute small- to medium-scale and/or complex technical projects, including process and equipment design engineering, estimating and budgeting, capital appropriation requests, documentation updates, scheduling, and project coordination and oversight.
Coordinate and execute technology-transfer projects for new clinical and commercial Exelead products and contract manufacturing opportunities; serve as the main technical interface with clients and contractors for contract manufacturing opportunities.
Provide project and process engineering support, including equipment specification and procurement, process development, drawing development, and protocol development and execution.
Interpret, modify, and create engineering drawings, including Piping and Instrumentation Diagrams, piping drawings, layouts, isometrics, and building mechanical, instrumentation, and electrical drawings.
Create and update Standard Operating Procedures for new and existing equipment and processes.
Perform process and utility calculations related to hydraulic design, heat transfer, and material balances.
Lead and provide technical support for process investigations.
Lead project-defined teams involving personnel from facility departments and outside contractors; manage small- to medium-scale project budgets and support facility projects, including clinical and commercial product technology transfers.
Perform special projects and other duties as assigned.