Manufacturing Operator, Purification – Wed–Sat 6am-4:30pm
About The Position
This position supports the Purification process team in a biopharmaceutical bulk products production facility, with a focus on safety, quality, and manufacturing performance under Manufacturing Standard for Operational Excellence (MSOE) 602. Purification operations use PLC-automated equipment controlled via HMI, including chromatography columns, chromatography and TFF skids, and intermediate product vessels. Manufacturing departments also use filtration technologies. The operator prepares and operates equipment according to written procedures, monitors processes, records information in accordance with cGMP standards, and supports equipment maintenance and troubleshooting. The role may also involve reviewing and revising manufacturing documents, participating in investigations or change controls, and training newer operators. The scheduled shift is Wednesday through Saturday, 6:00 a.m. to 4:30 p.m.
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.
- Ability to bend, reach, stretch, climb ladders, and work in tight spaces.
- Ability to stand for long periods.
- Ability to 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 MSOE 602.
- Record data, log activities, and monitor processes according to cGMP standards.
- Perform general maintenance and assist with equipment troubleshooting.
- Review batch records for completeness and accuracy.
- Author and/or revise standard operating procedures and batch records; may participate in non-conformance investigations and change controls.
- Train and coach junior or new operators.
- Maintain safety awareness and communicate safety issues to management in a timely manner.
- Follow company safety policies, including using required personal protective equipment.
- Follow the corporation’s safety, environmental, quality, and EEO/AA standards and policies.
- Perform all 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
Career Level
Mid Level
Education Level
High school or GED
