Manufacturing Purification Operator – Wed–Sat| 2:00pm-12:30am

Celltrion Branchburg, LLC•Branchburg Township, NJ

5d•Onsite

About The Position

This position is responsible for providing support to their respective process team per Manufacturing Standard for Operational Excellence (MSOE) 602, specifically focusing on safety, quality and manufacturing performance. Perform actual duties in an assigned area within the biopharmaceutical bulk products production facility. Duties are listed below and are specific to the assigned area (Cell Culture, Purification, or BioServices). The processing areas are PLC automated and controlled via HMI. Cell Culture operations contains major equipment such as bioreactors, centrifuges, and biosafety cabinets. Protein Purification operations contains major equipment such as chromatography columns, chromatography / TFF skids, and intermediate product vessels. BioServices encompasses Media Prep, Buffer Prep, and general equipment cleaning and preparation supporting both Cell Culture and Purification. Major equipment for this area includes stainless steel vessels, autoclaves, and washers. All three major manufacturing departments utilize filtration technologies.

Requirements

Minimum of 2 years of relevant experience
Ability to understand technical nomenclature and language as well as work with mathematical formulas.
Must have good manual dexterity and demonstrated mechanical aptitude.
Must be able to follow detailed instructions and record information clearly and accurately.
Must possess excellent communication, interpersonal, and written skills.
Demonstrated knowledge and experience in aseptic processing techniques.
Must be able to apply technical and operational experience to aid in problem solving activities.
Lifting of 50 pounds
Bend, reach, stretch, climb ladders, and work in tight spaces.
Stand for long periods.
Wear appropriate clean room attire.

Responsibilities

Prepare and operate equipment according to written procedures. Examples include setup and sterilization of components and process equipment, monitoring equipment parameters and making adjustments to operational settings, in-process sampling, and performing routine assays.
Responsible for providing support to their respective process team, per Manufacturing Standard for Operational Excellence (MSOE) 602.
Record data, log activities, and monitor processes according to cGMP standards.
Perform general maintenance and assists in troubleshooting of equipment.
Review batch records for completeness and accuracy.
Author and/or revise standard operating procedures and batch records. May participate in non-conformance event investigations and/or change controls.
Train/coach junior/new operators.
Maintain an elevated level of safety awareness. Communicate safety issues to management in a timely manner.
Strict adherence to all company safety policies including the use of PPE where required.
Adhere to all safety, environmental, quality, and EEO/AA standards and policies of the Corporation.
Perform all duties with a high level of honesty and integrity.