QC Lab Technician, 5th Shift (Weekend) – ISO 7

Datwyler; Town of Middletown (NY); On-site; USD 39,000 - 52,000; Full time

Job summary

Datwyler in the United States (New York) is seeking a Laboratory Technician for a 5th shift weekend position (Fri, Sat, Sun 11:00 p.m. – 11:30 a.m.) to ensure safety, efficacy, and compliance of primary packaging components.

You will perform end-to-end analytical testing of raw materials and finished products within an ISO 7 cleanroom, adhering to global cGMP standards and using SAP and LIMS for batch release and data entry.

Qualifications

• Education: High School diploma or GED; Associate’s or Bachelor’s degree in Microbiology, Biology, or Chemistry is highly preferred.
• Experience: 1–3 years in a regulated laboratory environment (Pharma, Biotech, or Medical Device).
• Technical Skills: Proficiency in MS Office and SAP; Familiarity with Minitab or similar statistical software; Hands-on cleanroom gowning and aseptic techniques.

Responsibilities

• Conducts daily microbiological and particulate monitoring of site water systems and cleanroom environments (ISO 7 or better) to ensure compliance with pharmacopeial standards.
• 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.
• Utilizes SAP and LIMS for batch release and real-time data entry.
• Applies statistical tools (e.g., Minitab) for Root Cause Analysis (RCA) and Out of Specification (OOS) investigations.
• Participates in the qualification (IQ/OQ/PQ) of new laboratory instrumentation (p. 1).
• Performs routine calibration and troubleshooting of sensitive analytical equipment.

Skills

Team orientation

Ownership over quality outcomes

Emotional intelligence

Strong communication

Education

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

High School Diploma/GED

Tools

SAP

LIMS

Minitab

MS Office

Job description

Datwyler in the United States (New York) is seeking a Laboratory Technician for a 5th shift weekend position (Fri, Sat, Sun 11:00 p.m. – 11:30 a.m.) to ensure safety, efficacy, and compliance of primary packaging components.

You will perform end-to-end analytical testing of raw materials and finished products within an ISO 7 cleanroom, adhering to global cGMP standards and using SAP and LIMS for batch release and data entry.