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Celltrion Inc · 4 days ago

Engineer - Technical Services/Manufacturing Sciences 2nd shift

Branchburg, NJ

Full-time

Onsite

Mid Level

$72K/yr - $120K/yr

Celltrion Inc is a biopharmaceutical company seeking an Engineer for their Technical Services/Manufacturing Sciences team. The role involves providing technical support for manufacturing operations, troubleshooting issues, and authoring technical reports while ensuring compliance with safety and regulatory expectations.

Health CarePharmaceutical

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. Has impact within department or local area

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

Qualification

Cell culture knowledgePurification processesGMP complianceProcess validationDatabase experienceTechnical report writingSpreadsheet experienceJMP experienceCoding experienceCommunication

Required

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

Knowledge of cell culture, purification and support systems used in the manufacturing of biotech products is required

Spreadsheet experience is required