Validation Specialist I

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 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 is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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 Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. 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.

Job Description

• Supports Eurofins DPT's business philosophy, leadership values, and ethics.

• Represents the organization in a professional manner through verbal and written communication.

• Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.

• Work with project manager(s) to complete responsibilities of validation projects within schedule, budget and quality constraints and function as project leadership when applicable.

• Guides the successful completion of major projects, generating internal and external reports and functions as project leader when applicable.

• Write, design, and develop validation protocols and support the reviews of the protocols to ensure the purpose, testing, and intended outcomes are defined and in compliance with Eurofins-DPT's validation program and applicable regulatory requirements.

• When applicable, writing laboratory procedures conforming to standardized format including revising Standard Operating Procedures.

• Can follow written instructions for the handling, management, and analysis of samples.

• Prepare samples for all applicable sites performing validations, qualifications, and/or customer studies.

• Able to troubleshoot systemic validation issues and resolve deviations and develop technical solutions for complex problems.

• Operates and navigate within DPT Laboratory Information Management System and reports.

• Independently provides and/or directs the technical validation support of process and/or equipment upgrades, replacements, and modifications in the laboratory.

• Work closely with department management providing support and technical advice for innovation, onboarding of new products, and process improvements.

• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

• Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures.

• Understands the application of regulatory standards and guidance documents and works with RA/QA personnel to ensure standards are met and update department management to updates on validation policies and procedures.

• Awareness of safety programs in compliance with laboratory regulations and assist with implementation of updated policies and procedures.

• Comfortable in interacting with inspectors (regulatory bodies; clients).

• 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.

• 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.

Candidates currently living within a commutable distance of Centennial, CO are encouraged to apply.

Qualifications

Basic Minimum Educational Requirements:

• Bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution

• If required by the State in which the laboratory is located, the appropriate State License to perform clinical laboratory testing

Basic Minimum Work Experience Requirements:

• Minimum 1 year of related experience

• Basic project management

• Knowledge of technical writing and study design

• Knowledge of regulatory standards that are applicable to method validation testing and analysis

• Knowledge of the principles, methods, materials, equipment, and techniques of medical technology

• Knowledge of the principles of chemistry, biology, and bacteriology as related to medical technology

• Skill in the use of medical laboratory equipment

• Capable of data analytics using relevant statistics and/or mathematics

• 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

• Ability to safely work within an environment in which potentially infectious human blood and body fluids are present, utilizing all appropriate personal protective equipment (PPE)

• Follows all Good Laboratory Practices and Good Documentation Practices

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

What we offer:

• 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

• Salary Range: $55,000-65,000

• Monday-Friday

Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.