The Manufacturing Operator III is responsible for performing and assisting with all processes related to the manufacture of Ocular Therapeutix products, including early stage clinical trial builds as well as commercial production builds.
Perform various manufacturing processes by following documented SOPs and procedures, calculating requirements, weighing materials, and operating various equipment. Processes include but are not limited to formulation, inspection and packaging
Complete documentation (batch records, process routers, forms, etc.) as required throughout the manufacturing process.
Apply cGMP and cGDP guidelines to all activities.
Work in an environmentally controlled area (clean room) as required.
Keep manufacturing areas orderly and clean according to associated SOPs.
Troubleshoot minor issues as they arise related to equipment and/or manufacturing processes.
Keep equipment operating by following operating instructions, troubleshooting breakdowns, and calling for repairs.
Identify and initiate deviation requests. Assist in determine the root cause and the corrective action to fix the issue.
Provide feedback and ideas about documentation and process improvements.
Perform other duties as required.
High School Diploma required, Bachelor’s Degree in a Engineering or bioscience field or equivalent preferred
2-4 years’ prior experience in the pharmaceutical
Clean room experience required
Chemical handling and solution preparation experience preferred
Basic computer knowledge, such as using Microsoft Word, Outlook and Excel
Must have very good written and oral communication skills as well as willingness to learn
Knowledge of FDA regulations, cGMP and cGDPs
Ability to interact with all manufacturing management team, manufacturing engineers, QC, R&D and other personnel
Excellent organizational skills and attention to detail with the ability to multitask