Manufacturing Technician II, In-Line Inspector - Sterile Filling

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The Manufacturing Technician II, In-Line Inspector supports sterile filling inspection operations, working in various Controlled/Non-Classified areas.

The role also supports improvement activities such as 5S, problem-solving, Kaizen events, and manual data collection, all in accordance with cGMPs.

• Operations Accountable for the outgoing quality level of inspected product; perform manual visual, cosmetic, and physical inspection of material, promptly escalating concerns to the Lead and Manager/Supervisor.
• Must obtain and maintain visual inspection qualification.
• Operate assigned machinery, including servicing automated inspection equipment, monitoring equipment status, reintroducing materials, manually palletizing inspected materials, and assuring a smooth flow of product.
• Start up equipment, make minor adjustments to machinery, remove jams, and perform minor troubleshooting and assembly/disassembly for cleaning.
• Use material handling equipment such as motorized and manual pallet jacks and non-motorized lifts.
• Perform cleaning, housekeeping and line clearance activities for assigned areas as required to maintain a cGMP environment.
• Apply knowledge of product security controls.
• Perform work in accordance with SOPs, cGMPs, and OSHA-compliant safety procedures, maintaining familiarity with job-related hazards and controls (PPE, ergonomics, LOTO, human/material/waste/chemical handling, and spill control) and area chemical Safety Data Sheets.
• Report all discrepancies to the process facilitator.
• Print SOPs and forms via ECMS.
• Support lean and process-improvement activities, including 5S, problem-solving, and manual tracking of OEE performance data.
• Review operational SOPs, forms, and batch records for accuracy, and suggest process improvements while maintaining quality and cGMP compliance.

• Perform batch record and GMP documentation entries; maintain records and logs as required, including mathematical computation where needed.
• Perform inventory control, reconciliation, and inventory movements using SAP in a limited role (e.g., moving items between storage locations and goods-issuing to process orders).

Acquire and maintain all required certifications and qualifications for the assigned work area, including cold room training/access to transfer materials in and out of the cold rooms.

Cross-train and support other work areas as needed.

• Prior experience in a regulated manufacturing environment (e.g., pharmaceutical, biotechnology, medical device, or other GMP-regulated industry) is preferred.
• Experience in manufacturing, quality, or visual inspection is highly desirable.
• Ability to effectively read, write, speak, and understand English to accurately interpret and follow Standard Operating Procedures (SOPs), batch records, work instructions, specifications, and other controlled documentation.
• Basic mathematical proficiency, including the ability to perform routine calculations involving weights, measures, percentages, and unit conversions, while accurately documenting inspection and production data.
• Ability to follow written procedures and standardized work with minimal supervision while recognizing abnormal conditions and appropriately escalating quality, safety, equipment, or process concerns.
• Strong…