Lead Manufacturing Operator - Wed-Sat| 6:00 AM-4:30 PM

Job Description

Job Description

Position Brand Description:  

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.

 

Key Objectives/Deliverables:  

Manage for Results /Strategic Planning:  

1. 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.
2. Responsible for providing support to their respective process team, per Manufacturing Standard for Operational Excellence (MSOE) 602.
3. Record data, log activities, and monitor processes according to cGMP standards.
4. Perform general maintenance and assists in troubleshooting of equipment.
5. Review batch records for completeness and accuracy.
6. Author and/or revise standard operating procedures and batch records. May participate in non-conformance event investigations and/or change controls.
7. Train/coach junior/new operators.
8. Serve as a leader on the floor; coordinate the work of others. Demonstrate the ability to analyze technical issues and implement improvements to existing process and solutions. May represent area in cross-functional meetings.
9. Maintain an elevated level of safety awareness. Communicate safety issues to management in a timely manner.
10. May have ownership or serve as content expert of a process or procedure.
11. Adhere to all safety, environmental, quality, and EEO/AA standards and policies of the Corporation.
12. Perform all duties with a high level of honesty and integrity.

Basic Requirements: 

1. Minimum of 5 years of relevant experience, or a minimum of 2 years high performance as Expert Operator.
2. Demonstrated high level of technical understanding within functional area, including full training on all aspects of routine processes.
3. Ability to understand technical nomenclature and language as well as work with mathematical formulas.
4. Must have good manual dexterity and demonstrated mechanical aptitude.
5. Must be able to follow detailed instructions and record information clearly and accurately.
6. Must possess excellent communication, interpersonal, and written skills.
7. Demonstrated knowledge and experience in aseptic processing techniques.
8. Must be able to apply technical and operational experience to aid in problem solving activities.
9. Must meet the physical requirements of the job; must have the ability to: 
10. Lift a minimum of 50lbs.
11. Bend, reach, stretch, climb ladders, and work in tight spaces. 
12. Stand for long periods. 
13. Wear appropriate clean room attire.

 

 

Education Requirements: 

1. BA/BS in biology, chemistry, or related discipline, or equivalent work experience.
2. High School Diploma required.

This role is nonexempt and the anticipated compensation for this role is $63,000 - $105,000.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role does not require travel but does require the ability to lift up to 50 lbs., on-call availability, and will involve shift work. Relocation assistance is not provided. 

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.

 

Wed-Sat 6:00 AM–4:30 PM