Environmental Monitoring - Sterile Liquids

Eurofins Scient. West Point , PA 19486

Posted 6 days ago

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 2019, Eurofins generated total revenues of EUR 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

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

  • Support pilot plant operations for the GMP manufacturing of sterile, biologic, and vaccine clinical supplies. Interfaces with a large network including multiple research, commercialization, commercial supply, and other pilot plants teams

  • Understand and execute classified facility and aseptic processing area EM Program requirements

  • Perform compliance improvement projects and manage change that supports improvement to the EM program and area sterility assurance

  • Investigate EM events (write and review investigations)

  • Trend and evaluate data (e.g. Classified facility Qualification, Requalification, Performance Qualification, Microbial Isolates review, Investigation trending, etc.)

  • Provide Subject Matter Expertise in sampling techniques and aseptic techniques, including training co-workers

  • Manage/maintain department EM metrics

  • Create and/or maintain EM schedules, sampling locations, and area sampling maps

  • Use LIMS to plan EM sampling tasks

  • SOP creation, update, review, and/or approval

  • Manage gown qualification program

  • Change control for EM

  • Routine EM tasks such as troubleshooting tester questions, particulate monitoring data review, etc.

  • Collaborate with Quality partners

  • Airflow Visualization Study protocol creation and completion

  • Utilities EM support, including gas and water sampling data trending

  • Maintain gown qualification status for access to aseptic manufacturing area

  • Classified facility HEPA filtered air velocity checks

  • Support aseptic processing area process simulations

  • Quality Risk Management. Participate in quality risk assessments

  • Support training, GMP, and safety initiatives

The ideal candidate would possess:

  • Previous experience in an EM role supporting sterile, biologic, or vaccine operations, and/or process development activities

  • Previous experience and knowledge of aseptic unit operations, including aseptic gown qualification

  • Previous experience and extensive knowledge of cGMPs

Basic Minimum Qualifications:

  • Bachelor's/Master's degree in microbiology, engineering, biomedical engineering, chemistry, biology, or related field with 1-2 years of relevant experience

  • Authorization to work in the United States indefinitely without restriction or sponsorship

Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.

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

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Environmental Monitoring - Sterile Liquids

Eurofins Scient.