3rd-Shift Lab Technician — GMP, Cleanroom QA

Datwyler; Town of Middletown (NY); On-site; USD 52,000 - 76,000; Full time

Job summary

Datwyler in the United States 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 pharmacopeial standards on a 3rd shift (Sun–Thu, 11:00 p.m.–7:30 a.m.).

Responsibilities include microbial and particulate monitoring, chemical/physical testing (FTIR, moisture, volatile sulfides), bioburden and endotoxin assays, calibration, and data entry

Qualifications

• High School Diploma or GED required; an Associate or Bachelor in Microbiology, Biology or Chemistry is highly preferred.
• 1–3 years of experience in a regulated lab (Pharma/Biotech/Medical Device).
• Proficiency with MS Office and SAP; familiarity with Minitab or similar statistics software.
• Hands-on experience with cleanroom gowning and aseptic techniques; strong teamwork and accountability.

Responsibilities

• Daily microbiological and particulate monitoring of site water systems and cleanroom environments (ISO 7 or better).
• Identify environmental trends and report them to prevent excursions.
• Perform chemical and physical testing on materials and batches (FTIR, moisture, volatile sulfides).
• Execute specialized tests (coring/fragmentation, penetration force, seal integrity).
• Conduct bioburden, endotoxin (LAL), and sub-visible particulate testing with automated equipment.
• Maintain accurate laboratory records and data entry in SAP/LIMS.
• Participate in RCA investigations using Minitab; assist IQ/OQ/PQ of new instrumentation.
• Perform routine calibration and troubleshooting of analytical equipment.

Skills

Team orientation

Emotional intelligence

Ownership over quality outcomes

Cleanroom gowning

Aseptic techniques

Education

High School Diploma/GED

Associate/Bachelor in Microbiology/Biology/Chemistry preferred

Tools

MS Office

SAP

LIMS

Minitab

Job description

Datwyler in the United States 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 pharmacopeial standards on a 3rd shift (Sun–Thu, 11:00 p.m.–7:30 a.m.).

Responsibilities include microbial and particulate monitoring, chemical/physical testing (FTIR, moisture, volatile sulfides), bioburden and endotoxin assays, calibration, and data entry