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Jobs · Management · New Jersey

Manufacturing Operator, Purification – Wed–Sat 6am-4:30pm

Celltrion Branchburg · Branchburg, NJ · 5 days ago
On-siteManagement$19–$34/hrFull-time

About the role

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 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.

Responsibilities

  • Prepare and operate equipment according to written procedures (e.g., setup and sterilization of components and process equipment, monitoring equipment parameters and making adjustments to operational settings, in-process sampling, and performing routine assays)
  • Provide support to 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 assist in troubleshooting of equipment
  • Review batch records for completeness and accuracy
  • Author and/or revise standard operating procedures and batch records
  • 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

Requirements

  • Minimum of 2 years of relevant experience
  • Ability to understand technical nomenclature and language as well as work with mathematical formulas
  • Good manual dexterity and demonstrated mechanical aptitude
  • Ability to follow detailed instructions and record information clearly and accurately
  • Excellent communication, interpersonal, and written skills
  • Demonstrated knowledge and experience in aseptic processing techniques
  • Ability to apply technical and operational experience to aid in problem solving activities
  • Meet physical requirements of the job:
    • Lifting of 50 pounds
    • Bend, reach, stretch, climb ladders, and work in tight spaces
    • Stand for long periods
    • Wear appropriate clean room attire

Education

  • Minimum HS degree with 2–4 years’ work experience
  • BA/BS in biology, chemistry, or related discipline, or equivalent work experience

Pay

This role is non-exempt. Anticipated compensation: $19/hr – $34/hr. This is a banded role; candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

Benefits

  • Paid time off (holidays, vacation, and additional leave)
  • Medical, dental, and vision insurance
  • Life insurance
  • Company-matched retirement savings plan
  • Wellness programs

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