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实验室技术员,负责原材料和成品的端到端分析测试,在ISO 7洁净室环境下工作并遵循全球cGMP标准。执行微生物监测、FTIR光谱分析、生物负荷和内毒素测试等专项检测,第三班次工作(周日至周四,晚11点至早7:30)。
Laboratory Technician 3rd Shift
Date: Aug 26, 2026
Location: Middletown, DE, US, 19709
Company: Datwyler
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...
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. This is a 3rd shift position, Sunday - Thursday, 11:00 p.m. - 7:30 a.m.
Essential Functions and 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.
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:
o Proficiency in MS Office and SAP.
o Familiarity with Minitab or similar statistical software.
o 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.
Be yourself at Datwyler
We are convinced that people make the difference. At Datwyler, you will experience diversity and a wide range of career opportunities that only an international company can provide. Together, we are increasing our agility, accelerating digitalization and fostering sustainability. For motivated and talented employees, we offer interesting development opportunities with training and assignments in a global environment. With us, you can contribute with all of your creativity and all your ideas.
www.datwyler.com
Nearest Major Market: Philadelphia
医药制造业
该职位为50%兼职的财务会计师,负责月度、季度和年度决算(HGB和IFRS),账户调节,增值税申报及流程优化。要求持有德国IHK证书,具备多年经验,德语和英语熟练。
负责生产线质量控制与检验,涵盖包装材料、空瓶、灌装及标签过程的质量验证。执行GMP、HACCP、FSSC 22000等食品安全标准,识别并控制不合格产品,维护质量记录并支持持续改进。要求食品技术、化学