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Validation Specialist Jobs

Company

Eurofins Lancaster Laboratories

Address Easton, MD, United States
Employment type FULL_TIME
Salary
Category Biotechnology Research
Expires 2023-07-22
Posted at 10 months ago
Job Description
Company Description


Eurofins Scientific is an international life sciences company which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment and pharmaceutical 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, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the key emerging players in specialty clinical diagnostic testing in Europe and the USA.


Group's key figures are approx. 5.4 billion Euros turnover, over 900 laboratories across 50 countries and about 55,000 staff.



If you’re seeking to become engaged in purposeful work that will have a far-reaching impact, Eurofins Agroscience Services (EAS) provides the environment you’re looking for. With more than 50 years’ experience in the crop protection industry, EAS offers a unique portfolio of expertise, providing extensive laboratory and field support across multiple industries including agrochemical, biopesticide, pharmaceutical, biocide, and fine chemical manufacturers.


When you join the EAS Group, you’ll become part a network of laboratories that prioritizes the execution of top-tier scientific studies. With access to specialized equipment and best-in-class instrumentation, you will collaborate with a team of highly trained scientists and study directors to rapidly build upon your existing skills set.


Eurofins Agroscience Services is searching for a Validation Specialist. This position can be located in either Columbia, MO or Easton, MD.


Validation Specialist responsibilities include, but are not limited to, the following:


  • Proactively plans and multitasks to maximize productivity.
  • Technical Writing - Author validation deliverables in accordance with established validation program. Review and approve validation deliverables developed by other team members. Develop, enhance, and/or provide guidance to other team members on software and instrumentation procedures. Develop and enhance validation and quality system program and procedures.
  • Validation Testing - Determine the approach to validate software and instrumentation. Provide quality project oversight, guidance, assistance with testing, and risk-based rationale to support approach. Review testing documentation generated by vendors, technical groups, and/or other validation team members. Summarize results and maintain documentation in an organized GLP compliant manner to demonstrate status.
  • Leadership - Demonstrated leadership and vision in managing staff groups and major projects or initiatives. A demonstrated commitment to high professional ethical standards and a diverse workplace. Excels at operating in a fast pace, community environment. Excellent people manager, open to direction and a collaborative work style and commitment to get the job done. Ability to challenge and debate issues of importance to the organization. Ability to look at situations from several points of view. Persuasive with details and facts. Delegates responsibility effectively. High comfort level working in a diverse environment.
  • Meets all quality and productivity metrics and demonstrates strong teamwork and collaboration.
  • Training - Provide guidance and coaching within a team environment. Provide training to technical groups and validation team members. Enhance/develop training program and procedures. Review documentation and provide constructive feedback to fellow team members.
  • Demonstrates strong client service skills, teamwork, and collaboration.
  • Validation Support - Accurately update validation program components. Perform evaluation of periodic review data for computerized systems. Provide oversight and/or perform e-record evaluations/remediation and provide guidance to technical groups.
  • Applies GLP in all areas of responsibility, as appropriate.
  • Applies the highest quality standard in all areas of responsibility.
  • Research - Independently research instrumentation with information obtained from vendors, manuals, and other resources to introduce new instruments. Integrate instrumentation into existing data center environments and workflows.
  • Compliance - Stay current with client, regulatory, validation, IT, and e-record compliance regulations, and requirements. Ensure projects are completed in compliance with existing quality systems. Interpret regulations and implement enhancements/improvements to existing quality systems. Utilize independent judgement and experience to make quality-based decisions. Interact with client and/or regulatory auditors and provide responses that align with company goals and policies.


Qualifications


The ideal candidate would possess:


  • Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Strong computer, scientific, and organizational skills
  • Excellent communication (oral and written) and attention to detail


Basic Minimum Qualifications


  • Ten years of laboratory software and/or analytical instrumentation research, installation, programming, networking, and/or validation. Experience must include five years of authoring and/or review of instrument validation deliverables (e.g., protocols, test scripts) within a GxP environment
  • Authorization to work in the United States indefinitely without restriction or sponsorship
  • Three years of regulatory experience including quality system/program development
  • In rare cases, comparable demonstrated competence and experience in the relevant area may be used to substitute in whole or in part for a degree candidate
  • A combination of college and related technical experience will be considered (e.g., 14+ years’ experience)
  • Bachelor’s degree in physical science, engineering, or information technology


Additional Information


Position is full-time, Monday-Friday, 8:00am to 5:00pm, with overtime required as needed. Candidates currently living within a commutable distance of Columbia, MO or Easton, MD are encouraged to apply.


What It’s Like To Work Here


Teamwork: experience what being a part of the Eurofins-EAG family feels like. Be inspired by your leaders, be encouraged by your teammates and be supported in all parts of your journey while you work with us.


Learning & Development: take on career development programs and goal setting to create big possibilities for your career and life. Develop within the company; be mentored and grown as a leader.


Diversity & Authenticity: we work hard to embrace diversity and inclusion and encourage everyone to bring their authentic selves to work every day.


Benefits & Perks To Foster Work/Life Balance


✓ Medical, Dental and Vision Coverage


✓ 401k Company Matching


✓ Paid Time Off


✓ Personal Days


✓ Wellness Program


✓ Education Assistance


✓ …and more!


If you enjoy being immersed in technology, tackling problems head-on, finding solutions through teamwork, and taking pride in accomplishments, join us today!


What Happens Next


Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths.


Your data


As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.


Closing Date


We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.


Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful.


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