Laboratory Technician

Datwyler


Job Location:

Middletown, DE - USA

Monthly Salary: Not Disclosed
Posted on: 15 days ago
Vacancies: 1 Vacancy

Job Summary

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 8000 employees the company headquartered in Switzerland generates annual sales of more than CHF 1000 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

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; Associates or Bachelors degree in Microbiology Biology or Chemistry is highly preferred.
Experience: 13 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.


Required Experience:

IC

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 heal...

About Company

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With recognized core competencies in solution design, material know-how and operational excellence, we are a strategic engineering partner for innovative systems in …

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