Engineer - TS/MS Process Support

Celltrion Branchburg, LLC•Branchburg Township, NJ

About The Position

This position is responsible for the technical support of manufacturing operations. This position will interact with the engineering, manufacturing, validation, quality assurance, quality control and regulatory departments. Interaction may be required with other Celltrion Branchburg, LLC site / contract producers of Celltrion products. Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required. Spreadsheet experience is required. Database experience a plus.

Requirements

BS degree in Chemistry, Microbiology, Biochemistry or related science, or BS in Chemical Engineering or related engineering discipline.
Position is a banded position and years of experience in a cGMP biopharmaceutical or pharmaceutical manufacturing and/or development environment will be considered in initial placement within the band.
Process and equipment knowledge of cell culture or purification functions.
Thorough understanding of GMP requirements for a large-scale manufacturing facility.
Excellent communication skills, both oral and written.

Nice To Haves

SQL database experience a plus.
JMP and coding experience a plus.
Process validation experience a plus.
Experience in cell culture and/or protein purification manufacturing a plus.

Responsibilities

Monitors (trends) and analyzes production data. Applies process knowledge and data analysis skills to support the management of daily manufacturing operations. Presents process data and analyses in Manufacturing Process Team meetings.
Troubleshoots issues in conjunction with Process Teams and/or manufacturing staff on the manufacturing floor. Anticipates and resolves problems. Communicates issues in a timely manner. Leads process-related investigations and assesses technical impact. Serves as a key resource within a TS/MS area or discipline. Gains support for ideas or positions on difficult issues. Assists in the transfer of processes from process development to production facilities and from one production facility to another, addressing scale-up issues.
May participate / lead in the transfer of processes from process development to production facilities and from one production facility to another, anticipating and addressing scale-up issues.
Authors technical reports supporting process control strategies, technology transfers, process validation, deviation/adverse event reporting, process monitoring/analyses, and technical studies.
Writes standard operating procedures and batch records as they relate to the activities of the TS/MS group. Reviews and approves manufacturing batch records and other manufacturing documentation.
Works directly with the Manufacturing staff on the manufacturing floor to share process knowledge. Assists in process-related training of Manufacturing Process Team members. As required, directly gathers additional supporting data on the manufacturing floor.
As required, designs laboratory experiments in support of process troubleshooting and/or continuous improvement and executes or coordinates execution in outside laboratories. Helps to define and implement continuous improvements and change controls to manufacturing processes.
Works with Manufacturing to support the start-up and validation of new facilities and the associated process equipment. Helps to implement control strategies for Celltrion Branchburg processes.
As required, may lead or assist in the planning and execution of process validation activities.
Understands, and performs all job responsibilities in compliance with, safety and regulatory expectations as well as cGMP.