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 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

Responsibilities :

• Participate in the development, validation, acceptance testing, and implementation of LIMS systems or related enhancements, in partnership with Merck IT and system vendors to meet the needs of various bioanalytical singleplex and multiplex assays.
• Develop a working knowledge of existing LIMS functionality as well as the data analysis requirements & acceptance criteria for various bioanalytical methods to setup assay data flows and LIMS analysis modules.
• Manage day to day LIMS activities for method qualification/validation and clinical study support including user training, troubleshooting, study setup, and management of clinical sample reconciliation and data transfers in line with regulatory data standards.
• Execute computer system validations, including the development of system requirements and acceptance test scripts, followed by formal system testing. Validation work may be conducted for either LIMS or associated laboratory computerized system.
• Operate within a regulated bioanalytical laboratory, participating as needed in regulatory audits as a LIMS subject matter expert.
• Develop departmental SOPs and related computer work instructions associated with LIMS or related systems.

Qualifications

Minimum Education Requirements:

• B.S. Degree in Biology, Chemistry (or related sciences), or Information Technology with at least 2-4 years of industry experience, an M.S. with 1-2 years of related experience

Required Experiences / Skills:

• Direct experience participating in computer system validations.
• Extensive experience utilizing or implementing custom or commercial Laboratory Information Management Systems (LIMS) in a regulated bioanalytical laboratory.
• Experience driving improvements for regulated bioanalytical data workflows either directly within a LIMs system or through other applications (e.g. Microsoft Excel)
• Capable of working independently under project timelines
• Strong collaborator, possessing both excellent verbal and written communication skills

Preferred Experiences / Skills:

• Experience working with vaccines bioanalytical assays, primarily those involved with immunogenicity or molecular based assessments
• Working knowledge of data delivery standards (e.g. CDISC) and applicability to bioa alytical data
• Strong MS Excel knowledge as well as general SQL query development skills and ability to understand database relationships and strictures
• Ability to develop process flow diagrams within existing tools (e.g. MS Visio)

Additional Information

Position is full-time and permanent, Monday-Friday 1st Shift with over time as needed. Candidates currently living in a commutable distance to West Point, PA are encouraged to apply.

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

Eurofins 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 websitewww.eurofinsus.com.

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