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.