Manufacturing Operator - Purification – Wed–Sat 2pm - 12:30am
About The Position
The Manufacturing Operator - Purification supports the assigned process team in a biopharmaceutical bulk products production facility, following Manufacturing Standard for Operational Excellence (MSOE) 602 and focusing on safety, quality, and manufacturing performance. The role performs duties in the assigned manufacturing area. Purification operations use PLC-automated equipment controlled through HMI, including chromatography columns, chromatography and TFF skids, intermediate product vessels, and filtration technologies. The operator prepares and operates equipment under written procedures, monitors processes, records information to cGMP standards, and supports equipment maintenance and troubleshooting. The role also includes reviewing batch records, contributing to procedures and records, supporting investigations or change controls when applicable, and training junior or new operators. The schedule is Wednesday through Saturday, 2:00 p.m. to 12:30 a.m. This is a non-exempt, banded role with anticipated compensation of $19–$34 per hour; placement within the range depends on experience, skills, internal equity, and market considerations.
Requirements
- At least 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 problem-solving activities.
- Ability to lift 50 pounds, bend, reach, stretch, climb ladders, work in tight spaces, stand for long periods, and wear appropriate cleanroom attire.
- Minimum high school degree with 2–4 years of work experience, or a BA/BS in biology, chemistry, or a related discipline, or equivalent work experience.
Responsibilities
- Prepare and operate equipment according to written procedures, including setting up and sterilizing components and process equipment, monitoring equipment parameters, adjusting operational settings, taking in-process samples, and performing routine assays.
- Support the assigned process team in accordance with Manufacturing Standard for Operational Excellence (MSOE) 602.
- Record data, log activities, and monitor processes according to cGMP standards.
- Perform general equipment maintenance and assist with troubleshooting.
- Review batch records for completeness and accuracy.
- Author or revise standard operating procedures and batch records.
- Participate in non-conformance event investigations and/or change controls as applicable.
- Train and coach junior or new operators.
- Maintain a high level of safety awareness and communicate safety issues to management in a timely manner.
- Follow company safety policies, including use of required personal protective equipment, and comply with safety, environmental, quality, and EEO/AA standards and policies.
- Perform duties with honesty and integrity.
Benefits
- Paid time off, including holidays, vacation, and additional leave.
- Medical insurance.
- Dental insurance.
- Vision insurance.
- Life insurance.
- Company-matched retirement savings plan.
- Wellness programs.
- Short- and long-term disability benefits.
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What This Job Offers
Job Type
Full-time
Education Level
High school or GED
