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Lyophilization & Packaging Operator

Job

Summit Works

Naperville, IL (In Person)

$62,400 Salary, Full-Time

Posted 2 weeks ago (Updated 1 week ago) • Actively hiring

Expires 7/13/2026

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Job Description

Lyophilization & Packaging Operator Summit Works - 4.0 Naperville, IL Job Details Full-time $20 - $40 an hour 4 hours ago Benefits Health insurance Paid time off Qualifications Chemical handling safety procedures Biochemistry GMP Cleanroom protocols Personal protective equipment (PPE) adherence Manufacturing standard operating procedures Manufacturing facility Chemistry Safety equipment Associate's degree Industrial chemical handling Standard operating procedures (SOPs) Chemical safety protocols Full Job Description Position summary The Lyophilization and Packaging Operator is the hands-on executor of freeze-drying and final-API packaging at Summit Works USA. Across two shifts, the Operator prepares bulk solution for fill, loads the lyophilizer, runs the qualified cycle, assesses the cake, and packages released bulk API into its final containers under controlled conditions. Key responsibilities The Operator completes the pre-cycle checklist with the Shift Lead, verifies bulk-solution release, performs gravimetric fill-weight verification, places thermocouples at qualified positions, seals the chamber within thirty minutes of fill, and initiates the qualified cycle at the Shift Lead's direction. Through the cycle the Operator reviews automated data at least every two hours, confirms logging is active, and escalates any pressure, product-temperature, or condenser excursion to the Shift Lead. At completion they perform the nitrogen backfill, assist with cake-appearance assessment, and transfer material to pre-labeled containers. On the packaging side, the Operator fills bulk API into HDPE amber bottles across the 10 g to 1000 g range under the controlled atmosphere and relative-humidity conditions specified for the product, verifies labels and container-closure, records fill weights, and cleans the chamber and line per the validated cleaning SOP. Required qualifications An Associate's degree in chemistry, pharmaceutical technology, or a related field is required, or a high-school diploma with substantial relevant laboratory or industrial experience, plus at least one year of hands-on experience (lyophilization, sterile fill, or packaging strongly preferred). The Operator must follow an MPCR with full fidelity, record per ALCOA+, and work safely with chemical and cold-temperature PPE. Preferred qualifications Prior lyophilization or packaging operator experience in pharmaceutical or peptide manufacturing is preferred, along with familiarity with bulk tray lyophilization and any prior cGMP experience. Physical requirements and working environment On-site, shift-based; the two openings cover the Day and Evening shifts, with off-shift response possible during validation. PPE including cold-rated gear for cold-room work and face shield for tray transfer; standing, lifting to fifty pounds, and cold-room work near four degrees Celsius.
Pay:
$20.00 - $40.00 per hour
Benefits:
Health insurance Paid time off
Work Location:
In person