Laboratory Technician – QC in ISO 7 Cleanroom (3rd Shift)

Datwyler Group; Town of Middletown (NY); On-site; USD 52,000 - 68,000; Full time

Job summary

Datwyler Group in New York state is seeking a Laboratory Technician to join 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 cGMP and regulatory standards.

The role operates on a 3rd shift (Sunday–Thursday, 11:00 p.m.–7:30 a.m.) and requires microbiology/chemistry background, 1–3 years in a regulated lab, and proficiency with SAP, LIMS, and statistical tools for RCA and OOS

Qualifications

• Minimum high school diploma required; associate or bachelor degree in Microbiology/Biology/Chemistry preferred.
• 1–3 years in a regulated laboratory environment (Pharma/Biotech/Medical Device).
• Proficiency in MS Office and SAP; familiarity with Minitab or similar statistics software.
• Hands-on experience with cleanroom gowning and aseptic techniques.
• Strong team orientation, ownership over quality outcomes, and good communication.

Responsibilities

• Daily microbiological and particulate monitoring of site water systems and cleanrooms (ISO 7 or better).
• Identify environmental trends to prevent microbial excursions before they affect production.
• Perform chemical and physical testing on raw materials and batches (FTIR, moisture, volatile sulfides).
• Execute specialized tests such as coring/fragmentation, penetration force, and seal integrity (CCIT).
• Conduct bioburden, endotoxin (LAL), and sub-visible particulate testing using automated equipment.
• Ensure laboratory records are attributable, legible, contemporaneous, original and accurate; use SAP and LIMS for batch release and data entry.
• Apply statistical tools (e.g., Minitab) for RCA and OOS investigations.
• Participate in IQ/OQ/PQ of new laboratory instrumentation and routine calibration/troubleshooting of equipment.

Skills

MS Office

Team orientation

Ownership of quality

Strong communication

Education

Bachelor's degree in Microbiology/Biology/Chemistry

Tools

SAP

LIMS

Minitab

Job description

Datwyler Group in New York state is seeking a Laboratory Technician to join 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 cGMP and regulatory standards.

The role operates on a 3rd shift (Sunday–Thursday, 11:00 p.m.–7:30 a.m.) and requires microbiology/chemistry background, 1–3 years in a regulated lab, and proficiency with SAP, LIMS, and statistical tools for RCA and OOS