You will execute routine unit operations within manufacturing assembly and packaging for drug product production in a multi-product facility.
Responsibilities
Execute assembly and packaging operations, including assisting with visual inspection and filling tasks.
Set up automated autoinjector, pre-filled syringe, and semi-automated tabletop assembly machines by gathering necessary tools, parts, and documentation.
Document all activities, events, and equipment verifications in controlled batch records, logbooks, and SOP attachments.
Troubleshoot mechanical and component issues in real-time to maintain production flow.
Maintain production area cleanliness through room sanitization, equipment removal, and waste disposal according to safety requirements.
Required Skills
5+ years of experience in manufacturing operations.
Direct experience working within GMP and cGMP environments.
Strict adherence to Standard Operating Procedures (SOP).
Proficiency in maintaining controlled documentation and batch records.
Ability to perform equipment calibration verification.
Experience with automated assembly machinery.
Background in drug product manufacturing or packaging.