Methods and Validations Technologist II
- Full-time
Company Description
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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organizations. It also has a rapidly developing presence in highly specialized and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralized and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
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
Methods and Validations Technologist II responsibilities include, but are not limited to, the following:
- Following and executing prescribed procedures and corporate policies, performing any of the tests within any of the laboratory specialties, calculating the results of the tests performed as necessary.
- Maintain contamination-free and proper clean room technique by using aseptic procedures and following all department cleaning and aseptic technique procedures
- Performs sample setups including, but not limited to: quarterly dose audit testing (sterility and bioburden), method suitability protocols, validations, and customer studies.
- Follows written instructions for the handling, management, and analysis of samples
- Understands the application of regulatory standards and guidance documents
- Generates dose audit reports and ensures data and analysis is captured accurately
- Work closely with various departments providing method suitability support for the routine testing departments, including the generation of client-specific methods
- Performs laboratory maintenance tasks per prescribed procedures (cleaning, equipment, reagents)
- Write the design and development of validation protocols and support the reviews of the protocols to ensure the purpose, testing, and intended outcomes are defined and in compliance with this sites Method Validation program and applicable standard requirements
- Generates internal and external validation reports and ensures data and analysis is captured accurately
- Identifies and assists with resolution of deviations encountered during testing executions
- Provide technical input to leadership and clients regarding the onboarding of a new product
- Work under moderate degree of supervision, referring complex and/or unusual problems to leadership
- Preparing reagents or media from a prescribed procedure
- Comply with departmental and company safety guidelines including proper use of PPE and chemicals
- Contribute to process improvements
- Utilizes laboratory information systems or other methods to accurately and effectively report results. Operates within our Laboratory Information Management System
- Reporting test results conforming to established procedures
- Supports Eurofins DPT’s business philosophy, leadership values, and ethics
- Follows all Good Laboratory Practices and Good Documentation Practices
- Represents the organization in a professional manner through verbal and written communication
- Performs administrative activities by performing day-to-day tasks such as maintaining information files and processing paperwork needed for others to generate customer reports and work instructions for Operations.
- Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.
- In order to meet Eurofins DPT’s quality policy and objectives, all employees are expected to meet basic expectations of Eurofins DPT’s quality management system including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, and accurate recordkeeping.
Qualifications
MINIMUM EDUCATIONAL REQUIREMENTS
- Bachelor’s degree in chemical, physical, biological or clinical laboratory science or medical technology form an accredited institution
WORK EXPERIENCE REQUIREMENTS
- Minimum 1-3 years of related experience
- Knowledge of regulatory standards that are applicable to testing and analysis for method suitability, bioburden, and sterility testing
- Knowledge and experience of the principles, methods, materials, equipment, and techniques associated with the job description
- Knowledge and experience of the principles of chemistry, biology, and bacteriology associated with the job description
- Skill in the use of laboratory equipment
- Capable of data analytics
- Strong communication skills and analytical thinking
- Ability to troubleshoot
- Ability to perform assigned tasks according to prescribed procedures and to make accurate observations and records of tests results
- Attention to detail and ability to adhere to strict procedures to prevent contamination of samples, equipment, and CTEs
- Interpersonal skills demonstrating the ability to work well with others in a fast-paced
- Authorization to work in the United States indefinitely without restriction or sponsorship
POTENTIAL ENVIRONMENTAL FACTORS
- This laboratory carefully maintains all hazardous materials. All employees must abide by Eurofins DPT’s Safety and Exposure procedures. This includes using the provided safety clothing and equipment.
- For a list of potential chemical hazards, see appropriate SDS sheet.
Additional Information
This position is full time, Monday through Friday, 8:00am - 5:00pm (weekends as needed), with overtime, as needed. Candidates currently living within a commutable distance of Centennial, CO are encouraged to apply.
- Compensation: $25.00/hr - $35.00/hr
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Please be aware that this role will require access to a site that requires COVID-19 vaccination or exemption from vaccination requirements. Prior to starting work in this position, employees must show proof of full Covid-19 vaccination or exemption from vaccination requirements. Exemptions will be granted as warranted by medical contraindications, disability or sincerely held religious beliefs.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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