Laboratory Technician

Datwyler•Middletown, NJ

5h•Onsite

About The Position

The Laboratory Technician is a critical member of the Quality Control team, ensuring the safety, efficacy, and compliance of primary packaging components for the healthcare industry. You will be responsible for the end-to-end analytical testing of raw materials and finished products, operating within a high-standard ISO 7 cleanroom environment and adhering to global cGMP.

Requirements

Minimum High School Diploma/GED; Associate’s or Bachelor’s degree in Microbiology, Biology, or Chemistry is highly preferred.
1–3 years in a regulated laboratory environment (Pharma, Biotech, or Medical Device).
Proficiency in MS Office and SAP.
Familiarity with Minitab or similar statistical software.
Hands-on experience with cleanroom gowning and aseptic techniques.
Strong team orientation, emotional intelligence, and a high degree of ownership over quality outcomes.

Responsibilities

Conducts daily microbiological and particulate monitoring of site water systems and cleanroom environments (ISO 7 or better) to ensure compliance with pharmacopeial standards.
Identifies and reports environmental trends to prevent microbial excursions before they impact production.
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.
Ensures all laboratory records are Attributable, Legible, Contemporaneous, Original, and Accurate.
Utilizes SAP and LIMS (Laboratory Information Management Systems) 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.
Performs routine calibration and troubleshooting of sensitive analytical equipment.