Eurofins
Device Development Scientist
Eurofins, Gaithersburg, Maryland, us, 20883
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.Job Description
General Responsibilities:The candidate will be responsible for the following activities:Design, develop and execute experiments (DOE) for device characterization and evaluation with minimum supervision.Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, and reports with minimum supervision.Perform test method qualification and GMP testing in support of device verification & validation testing.Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/MDD/GMP/GLP, 21CRF Part 4 & 820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards.Qualifications
Desired Skills:Hands on technical experience with Container Closure Integrity (CCI) test methods.It’s a plus to be an accomplished user of Container Closure Integrity (CCI) techniques and test methods used for parenteral products (such as Dye Ingress, High Voltage Leak Detection (HVLD), Mass Extraction, or vacuum decay).Experience with testing software/tool/equipment such as INSTRON tensile test machine, confocal and/or light microscopy, Solidworks, Minitab, Labview, Matlab, etc.Prior experience working with prefilled syringes, autoinjectors, and/or other drug delivery devices is a plus.Knowledge of medical/combination device verification & validation is a plus.Knowledge of global industry standards (e.g., ISO, AAMI, ANSI, etc.) applicable to device and/or combination product development is a plus.The Hiring Process:
10-15 Minute Call with Recruiter60 Minute Virtual Interview with Group Leader or Site ManagerAdditional Information
The position is full-time, Monday - Friday 8 am - 5 pm. Candidates living within a commutable distance of Gaithersburg, MD are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options:Life and disability insurance401(k) with company matchPaid vacation and holidaysEurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.To learn more about Eurofins Lancaster Laboratories, please explore our website
www.eurofinsus.com .Eurofins is an M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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General Responsibilities:The candidate will be responsible for the following activities:Design, develop and execute experiments (DOE) for device characterization and evaluation with minimum supervision.Make detailed observations, data analysis, interpret results, maintain documentation, and prepare technical reports, summaries, and reports with minimum supervision.Perform test method qualification and GMP testing in support of device verification & validation testing.Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. ISO/MDD/GMP/GLP, 21CRF Part 4 & 820.30 and applicable safety requirements. Prepare and maintain documentation and formal reports in accordance with these standards.Qualifications
Desired Skills:Hands on technical experience with Container Closure Integrity (CCI) test methods.It’s a plus to be an accomplished user of Container Closure Integrity (CCI) techniques and test methods used for parenteral products (such as Dye Ingress, High Voltage Leak Detection (HVLD), Mass Extraction, or vacuum decay).Experience with testing software/tool/equipment such as INSTRON tensile test machine, confocal and/or light microscopy, Solidworks, Minitab, Labview, Matlab, etc.Prior experience working with prefilled syringes, autoinjectors, and/or other drug delivery devices is a plus.Knowledge of medical/combination device verification & validation is a plus.Knowledge of global industry standards (e.g., ISO, AAMI, ANSI, etc.) applicable to device and/or combination product development is a plus.The Hiring Process:
10-15 Minute Call with Recruiter60 Minute Virtual Interview with Group Leader or Site ManagerAdditional Information
The position is full-time, Monday - Friday 8 am - 5 pm. Candidates living within a commutable distance of Gaithersburg, MD are encouraged to apply. Excellent full-time benefits including comprehensive medical coverage, dental, and vision options:Life and disability insurance401(k) with company matchPaid vacation and holidaysEurofins Lancaster Laboratories Professional Scientific Services (PSS) is a global, award-winning insourcing solution that places our people at our clients’ site dedicated to running and managing laboratory services while eliminating headcount, co-employment, and project-management worries.We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client’s quality systems and equipment.To learn more about Eurofins Lancaster Laboratories, please explore our website
www.eurofinsus.com .Eurofins is an M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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