Sr Process Engineer

Merck•Indianapolis, IN

About The Position

The Sr Process Engineer executes business-unit-driven process development programs by applying fundamental engineering principles in a cGMP environment 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 continued support for complex formulations, including PEGylated, liposomal, and lipid nanoparticle (LNP) formulations. The engineer facilitates the transfer and introduction of new chemical processes from development laboratories or clients into full-scale manufacturing, and supports process improvement and optimization. The position leads project-defined teams drawn from facility departments and outside contractors, and supports facility projects ranging from clinical and commercial product technology transfers to other projects of varying value.

Requirements

B.S. or M.S. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Engineering, or a related field.
At least five 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.
Self-motivated, highly organized, and conscientious, with effective interpersonal skills for working with internal and external clients and contractors.
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 and ability to coordinate multiple projects concurrently.
Strong mediation skills to gain and maintain cross-departmental project support.
Availability to work outside standard operating shift hours occasionally as needed to maintain the production schedule.
Advanced PC skills with spreadsheets, word processing, and databases.
Knowledge of Microsoft Project or similar project-scheduling software.
Knowledge of root cause analysis methodology and FMEA or another program.
Knowledge of Microsoft Visio, AutoCAD, or similar drawing software, and Minitab, JMP, or similar statistical software.

Nice To Haves

Experience with lipid nanoparticles, liposomes, PEGylated formulations, lyophilization unit operations, and/or other nanomedicinal parenteral products.
Strong hands-on skills.
Previous training in project management skills, Kepner-Tregoe, or another program.

Responsibilities

Provide technical support for manufacturing processes, including investigations, continuous improvement, technology transfer, and scale-up of new product introductions.
Develop subject-matter expertise across multiple product lines from preclinical through commercial, with desired expertise 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, estimating and budgeting, capital appropriation requests, documentation updates, scheduling, and project oversight.
Coordinate and execute technology-transfer projects for new clinical and commercial Exelead products and contract manufacturing opportunities.
Act as the main technical interface with internal and external 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, building mechanical drawings, and instrumentation and electrical drawings.
Create standard operating procedures for new equipment and processes and update existing procedures.
Perform process and utility calculations related to hydraulic design, heat transfer, and material balances.
Lead and provide technical support for process investigations.
Lead and supervise project teams comprising facility personnel and outside contractors.
Manage budgets for small- to medium-scale projects and support facility projects, including clinical and commercial product technology transfers.