Sr. Process Engineer

Celltrion Branchburg, LLC•Branchburg Township, NJ

5d•$87,000 - $150,000•Hybrid

About The Position

This position is responsible for providing engineering support of manufacturing equipment and operations. This position will interact various team members on Process Team, including TS/MS, manufacturing, validation, and quality assurance, and other Celltrion Sites as required. Knowledge of cell culture, purification and support systems, and its associated bioprocessing equipment used in the manufacturing of biotech products is required.

Requirements

3+ years industrial experience in a cGMP environment, or experience through education.
Knowledge of / experience with several biopharmaceutical processes and equipment, such as bioreactors, centrifuges, TFF and chromatography systems, media/buffer prep and CIP/SIP.
Strong written and oral communication skills.
Aggressive, curious, and solution driven. Self-directed personality, with ability to work independently, self-sufficiently, and proactively in the performance of work duties.

Responsibilities

Responsible for planning, coordinating, and executing projects supporting clinical and commercial manufacturing operations.
Use historian data and other sources of process data to extract and chart relevant process parameters on a continuous basis. Uses process knowledge to analyze possible solutions to solve a range of problems.
Ensure regulatory compliance from an equipment and process performance aspect. Understand capability and capacity of unit operations and process. Active participation in Process Teams to verify that process is in control; use of first principles, RCA or other tools to reach conclusion and recommendations for remediation of any problems or deviations.
Supports Process Team by responding to questions and sharing process knowledge. Respond to operations needs and handles standard and non-standard requests.
Lead equipment related investigation and resolutions. Provide process related input to process team for investigations. Make decisions that impact own priorities and allocation of time to meet deadlines.
Execute, or assist, in process related change controls. Own equipment Standard Operating Procedures (SOP), related CAPAs and changes. Perform safety assessments as required for change controls and any project related activity. Effect incremental improvement.
Perform key responsibilities of discipline other than Process Engineering; Automation – support measurement and control systems, Maintenance – ensuring an asset’s functionality is maintained.
Creates or modifies SOPs for Engineering procedures as required. Own manufacturing SOP’s and participates in the reviews and approvals of operational SOPs and Manufacturing Batch Records, ensuring procedures can be executed as written to ensure practice matches procedure, as it relates to the process equipment and order of operations.
Provide engineering support to Senior engineers for new product introduction, capital projects, and shutdown related activity.
Performs all job functions with adherence to company policies, in a cGMP manner, safely and ethically