Pharma QC Lab Technician - Cleanroom & cGMP
Datwyler Group
In billions of syringes and in every second car worldwide, Datwyler components make an important contribution to the safety of patients and drivers. The high‑tech company focuses on high‑quality, system‑critical elastomer components and holds leading positions in attractive global markets such as healthcare, mobility, connectivity, general industry and food & beverage. With over 25 production sites on four continents, sales in more than 100 countries and over 8,000 employees, the company, headquartered in Switzerland, generates annual sales of more than CHF 1,000 million. Our employees are the heart of Datwyler – we treat each other with respect, trust and appreciation. We have strong roots and values that have been well established in our 100‑year corporate history. Become part of our great team as a Laboratory Technician. Summary 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. Essential Functions And Responsibilities Conduct daily microbiological and particulate monitoring of site water systems and cleanroom environments (ISO 7 or better) to ensure compliance with pharmacopeial standards. Identify and report environmental trends to prevent microbial excursions before they impact production. Perform chemical and physical testing on raw materials and batches, including FTIR spectroscopy, moisture analysis, and 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 all laboratory records are Attributable, Legible, Contemporaneous, Original, and Accurate. Utilize SAP and LIMS (Laboratory Information Management Systems) for batch release and real‑time data entry. Apply statistical tools (e.g., Minitab) for Root Cause Analysis (RCA) and Out of Specification (OOS) investigations. Participate in the qualification (IQ/OQ/PQ) of new laboratory instrumentation. Perform routine calibration and troubleshooting of sensitive analytical equipment. Requirements Education: Minimum High School Diploma/GED; Associate’s or Bachelor’s degree in Microbiology, Biology, or Chemistry is highly preferred. Experience: 1–3 years in a regulated laboratory environment (Pharma, Biotech, or Medical Device). Technical Skills: Proficiency in MS Office and SAP. Familiarity with Minitab or similar statistical software. Hands‑on experience with cleanroom gowning and aseptic techniques. Soft Skills: Strong team orientation, emotional intelligence, and a high degree of ownership over quality outcomes. #J-18808-Ljbffr Datwyler Group
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