Laboratory Technician 4th Shift (Middletown, DE, US)

Datwyler; Town of Middletown (NY); Hybrid; USD 55,000 - 75,000; Full time

Job summary

Datwyler in the United States is seeking a Laboratory Technician for the Quality Control team. You will perform end-to-end analytical testing of raw materials and finished products in an ISO 7 cleanroom, ensuring compliance with global cGMP, in a 4th shift: Fri-Sun 11:00 a.m.–11:30 p.m.

Responsibilities include microbiological and chemical testing, data entry in SAP/LIMS, and contributing to RCA investigations, calibration, and instrument qualification, with a strong emphasis on accuracy and

Qualifications

• Minimum High School Diploma/GED; Associate’s or Bachelor’s in Microbiology, Biology, or Chemistry preferred.

Responsibilities

• Conducts daily microbiological and particulate monitoring of site water systems and cleanrooms to ensure pharmacopeial compliance.
• 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 for batch release and real-time data entry.
• Applies statistical tools (e.g., Minitab) for RCA and OOS investigations.
• Participates in IQ/OQ/PQ of new laboratory instrumentation.
• Performs routine calibration and troubleshooting of analytical equipment.

Skills

Aseptic techniques

Quality ownership

Root Cause Analysis

Statistical analysis

Education

Bachelor’s or Associate degree in Microbiology/Biology/Chemistry

Tools

MS Office

SAP

Minitab

Job description

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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 4th Shift position, Friday, Saturday, and Sunday 11:00 a.m. to 11:30 p.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 (p. 1).
• 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:
• 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.

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.