Pharma QC Lab Technician – ISO 7 Cleanroom, 4th Shift

Datwyler; Town of Middletown (NY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Datwyler in the United States is seeking a Laboratory Technician for the Quality Control team. You will perform end-to-end analytical testing of raw materials and finished products in an ISO 7 cleanroom, ensuring compliance with global cGMP, in a 4th shift: Fri-Sun 11:00 a.m.–11:30 p.m.

Responsibilities include microbiological and chemical testing, data entry in SAP/LIMS, and contributing to RCA investigations, calibration, and instrument qualification, with a strong emphasis on accuracy and

Qualifications

• Minimum High School Diploma/GED; Associate’s or Bachelor’s in Microbiology, Biology, or Chemistry preferred.

Responsibilities

• Conducts daily microbiological and particulate monitoring of site water systems and cleanrooms to ensure pharmacopeial compliance.
• Identifies and reports environmental trends to prevent microbial excursions before they impact production.
• Performs chemical and physical testing on raw materials and batches, including FTIR spectroscopy, moisture analysis, and volatile sulfides.
• Executes specialized tests such as coring/fragmentation, penetration force, and seal integrity (CCIT).
• Conducts bioburden, endotoxin (LAL), and sub-visible particulate testing using automated equipment.
• Ensures all laboratory records are Attributable, Legible, Contemporaneous, Original, and Accurate.
• Utilizes SAP and LIMS for batch release and real-time data entry.
• Applies statistical tools (e.g., Minitab) for RCA and OOS investigations.
• Participates in IQ/OQ/PQ of new laboratory instrumentation.
• Performs routine calibration and troubleshooting of analytical equipment.

Skills

Aseptic techniques

Quality ownership

Root Cause Analysis

Statistical analysis

Education

Bachelor’s or Associate degree in Microbiology/Biology/Chemistry

Tools

MS Office

SAP

Minitab

Job description

Datwyler in the United States is seeking a Laboratory Technician for the Quality Control team. You will perform end-to-end analytical testing of raw materials and finished products in an ISO 7 cleanroom, ensuring compliance with global cGMP, in a 4th shift: Fri-Sun 11:00 a.m.–11:30 p.m.

Responsibilities include microbiological and chemical testing, data entry in SAP/LIMS, and contributing to RCA investigations, calibration, and instrument qualification, with a strong emphasis on accuracy and