QC Laboratory Technician - Night Shift (ISO 7 Cleanroom)

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

Job summary

Datwyler is seeking a Laboratory Technician to join the Quality Control team for end-to-end analytical testing of materials and finished products in a strict ISO 7 cleanroom, under cgMP. This role operates on the 3rd shift, Sunday through Thursday, 11:00 p.m.

to 7:30 a.m., contributing to the safety and efficacy of healthcare packaging components. You will use FTIR, moisture analysis, and VOC testing, support with LIMS/SAP data, and apply statistical methods for root cause analysis and

Qualifications

• High School Diploma or GED required; degree in Microbiology, Biology, or Chemistry preferred.
• 1–3 years in a regulated lab environment (Pharma/Biotech/Medical Device).
• Proficiency in MS Office and SAP; familiarity with Minitab; cleanroom gowning and aseptic techniques.

Responsibilities

• Conduct daily microbiological and particulate monitoring in ISO 7 cleanrooms and water systems.
• Identify and report environmental trends to prevent microbial excursions.
• Perform chemical and physical testing on raw materials and batches (FTIR, moisture, VOCs).
• Execute specialized tests (coring/fragmentation, penetration force, seal integrity).
• Conduct bioburden, endotoxin (LAL), and sub-visible particulate testing.
• Maintain laboratory records that are Attributable, Legible, Contemporaneous, Original, and Accurate.
• Utilize SAP and LIMS for batch release and data entry; apply Minitab for RCA and OOS investigations.
• Assist in IQ/OQ/PQ qualifications of new lab instrumentation; calibrate and troubleshoot instruments.

Skills

Strong team orientation

Emotional intelligence

Ownership over quality outcomes

Education

High School Diploma or GED

Associate's or Bachelor's in Microbiology/Biology/Chemistry

Tools

MS Office

SAP

Minitab

Job description

Datwyler is seeking a Laboratory Technician to join the Quality Control team for end-to-end analytical testing of materials and finished products in a strict ISO 7 cleanroom, under cgMP. This role operates on the 3rd shift, Sunday through Thursday, 11:00 p.m.

to 7:30 a.m., contributing to the safety and efficacy of healthcare packaging components. You will use FTIR, moisture analysis, and VOC testing, support with LIMS/SAP data, and apply statistical methods for root cause analysis and