Laboratory Technician 5th Shift (Middletown, DE, US)

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

Job summary

Datwyler is seeking a Laboratory Technician for a 5th shift weekend position (Friday–Sunday, 11:00 p.m. to 11:30 a.m.) to join the Quality Control team in ensuring the safety, efficacy, and compliance of primary packaging components for healthcare.

You will conduct end-to-end analytical testing of raw materials and finished products in a high-standard ISO 7 cleanroom and adhere to global cGMP. You will utilize SAP and LIMS for batch release and data entry, and apply statistical tools like

Qualifications

• 1–3 years in a regulated laboratory environment (Pharma, Biotech, or Medical Device).
• Experience with ISO 7 cleanroom environments and cGMP is preferred.
• Hands-on experience with analytical testing and data recording in SAP/LIMS is desirable.

Responsibilities

• Conduct daily microbiological and particulate monitoring of site water systems and cleanrooms (ISO 7 or better).
• Identify and report environmental trends to prevent microbial excursions.
• Perform chemical and physical testing on raw materials and batches (FTIR, moisture, sulfides).
• Execute specialized tests such as coring/fragmentation, penetration force, and seal integrity (CCIT).
• Perform bioburden, endotoxin (LAL), and sub-visible particulate testing using automated equipment.
• Ensure laboratory records are Attributable, Legible, Contemporaneous, Original, and Accurate.

Skills

Team orientation

Emotional intelligence

Ownership of quality

Education

High School Diploma/GED

Associate or Bachelor 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 5th Shift weekend position, Friday, Saturday, and Sunday 11:00 p.m. to 11:30 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 (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.