Manufacturing Operator Purification – Wed–Sat| 6:00am - 4:30pm

About the role

This position provides support to the respective process team per Manufacturing Standard for Operational Excellence (MSOE) 602, focusing on safety, quality and manufacturing performance. Duties are performed in an assigned area within the biopharmaceutical bulk products production facility and vary by area (Cell Culture, Purification, or BioServices). All areas utilize PLC-automated equipment controlled via HMI.

Responsibilities

• Prepare and operate equipment according to written procedures: setup and sterilization of components and process equipment, monitoring and adjusting operational settings, in-process sampling, and routine assays.
• Provide support to the respective process team per 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 as needed.
• Train and coach junior/new operators.
• Maintain an elevated level of safety awareness; communicate safety issues to management in a timely manner; adhere to all company safety policies including use of required PPE.
• 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.

Area-specific context

• Cell Culture: Major equipment includes bioreactors, centrifuges, and biosafety cabinets.
• Protein Purification: Major equipment includes chromatography columns, chromatography/TFF skids, and intermediate product vessels.
• BioServices: Encompasses Media Prep, Buffer Prep, and general equipment cleaning and preparation supporting Cell Culture and Purification. Major equipment includes stainless steel vessels, autoclaves, and washers.
• All three departments utilize filtration technologies.

Requirements

• Minimum of 2 years of relevant experience.
• Ability to understand technical nomenclature and language and 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.
• Meets the physical requirements of the job:
  • Lifting up to 50 pounds.
  • Bending, reaching, stretching, climbing ladders, and working in tight spaces.
  • Standing for long periods.
  • Wearing appropriate cleanroom attire.

Education

• Minimum high school diploma with 2–4 years of relevant work experience.
• BA/BS in biology, chemistry, or related discipline, or equivalent work experience.

Pay

The anticipated compensation for this role is $19/hr – $34/hr. 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.
• Short- and long-term disability benefits.