Technical Document Specialist H/F Eurofins

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation 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 Organisations. It also has a rapidly developing presence in highly specialised 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 decentralised 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

As a Technical Document Author, you will play a vital role in the analytical method and statistical teams, executing tasks in a Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) compliant manner. You will work under the direction of client Subject Matter Experts (SMEs), performing basic functions independently and progressively learning more complex tasks. This position is essential for maintaining operational efficiency and ensuring adherence to analytical tech transfer standards.

- Authoring and/or reviewing technical documents to support method transfer (e.g. method transfer protocols and associated reports)
- Support for global filings, including author of method description and validation sections
- Maintain current cGMP training and safety training as per site requirements
- Comply with cGMP, Standard Operating Procedures (SOPs), and safety regulations in all activities
- Report any potential quality events or non-conformance to GMPs/SOPs as soon as they are observed
- Ensure all documentation is accurately completed following Good Documentation Practices (GDP)

Qualifications

Minimum Requirements:

- Bachelor of Science (Biology, Chemistry, Biochemistry or related sciences)
- Scientific technical writing experience
- Detail-oriented with knowledge of cGMP documentation (ALCOA+)
- Experience with large molecule (vaccine and/or biologics) methods platforms (e.g. HPLC/UPLC, ELISA, Biochemical methods)
- Authorization to work in the United States

Preferred Experience and Skills:

- A minimum of 1 years of experience working in a GMP laboratory environment
- Analytical method validation or method transfer experience
- Experience in using digital validation platform software, electronic notebooks, and/or Laboratory Information Management Systems (LIMS)

Additional Information

Positions are full-time, Monday - Friday 8am - 5 pm with overtime as needed. Candidates currently living within a commutable distance of 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
- Yearly goal-based bonus & eligibility for merit-based increases

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.