Night-Shift Laboratory Technician: Cleanroom QA & Analysis

Datwyler Group; Delaware (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

The Laboratory Technician at Datwyler is a critical member of the Quality Control team, ensuring the safety, efficacy, and compliance of primary packaging components for healthcare. You will conduct end-to-end analytical testing of materials and finished products in an ISO 7 cleanroom, adhering to cGMP, on a 3rd shift schedule (Sun–Thu, 11:00 p.m.–7:30 a.m.).

This role requires 1–3 years in a regulated lab, proficiency with MS Office and SAP, and experience with LIMS, FTIR, and aseptic

Qualifications

• Education: High School diploma or GED; associate/bachelor preferred.
• 1–3 years in a regulated pharma/biotech/medical device lab.
• Proficient with MS Office and SAP.
• Experience with cleanroom gowning and aseptic techniques.

Responsibilities

• Daily microbiological and particulate monitoring of water systems and cleanrooms.
• Identify and report environmental trends to prevent excursions.
• Perform chemical and physical testing on materials and batches (FTIR, moisture, VOCs).
• Execute tests like coring/fragmentation, penetration force, seal integrity.
• Conduct bioburden, endotoxin (LAL), and sub-visible particulate testing.
• Maintain lab records to be Attributable, Legible, Contemporaneous, Original, Accurate.
• Use SAP and LIMS for batch release and data entry.
• Apply statistics (Minitab) for RCA and OOS investigations.
• Participate in IQ/OQ/PQ of new lab instrumentation.
• Routine calibration and troubleshooting of analytical equipment.

Skills

MS Office

SAP

Minitab

Aseptic techniques

Cleanroom gowning

Team orientation

Emotional intelligence

Quality ownership

Education

High School Diploma/GED

Associate/Bachelor in Microbiology/Biology/Chemistry

Tools

LIMS

FTIR

Job description

The Laboratory Technician at Datwyler is a critical member of the Quality Control team, ensuring the safety, efficacy, and compliance of primary packaging components for healthcare. You will conduct end-to-end analytical testing of materials and finished products in an ISO 7 cleanroom, adhering to cGMP, on a 3rd shift schedule (Sun–Thu, 11:00 p.m.–7:30 a.m.).

This role requires 1–3 years in a regulated lab, proficiency with MS Office and SAP, and experience with LIMS, FTIR, and aseptic