Company Description

The work we do at Eurofins Professional Scientific Services matters, and so do our employees. At Eurofins PSS, we put a focus on your professional growth. We provide our employees the ability to break into the biopharmaceutical industry and grow from the bottom up. We have the supportive teams and tools available to invest in you while also affording you work-life balance and a competitive benefits package.

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.

If you’re looking for a rewarding career, a place to call home, apply with us today!

Job DescriptionPerform sterility, endotoxin, pH and osmolality testing on raw materials, drug substance, and drug productPerform gram stains, sub-culturing of isolates, growth promotion testing, and general cell cultureCoordinate, schedule, and execute testing based on manufacturing schedulesDirect performance in Aseptic Processing Media Fills and perform support testing, including visual inspectionMaintain housekeeping and equipment maintenance including organization, cleanliness, and logbooksAssist the Quality Control department in daily operations, as neededAuthor and revise QC SOPs and change controls as necessary to maintain complianceAuthor and execute qualification protocols and reports for microbiological assaysPerform timely response to Out of Specification (OOS) results, including notification to area management. Perform and document laboratory investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrent are considered implemented. Execute associated CAPA.Ensure data integrity is maintained for all applications, programs, and executed work. Ability to document all work using Good Documentation Practices and ALCOA++ principles.Troubleshoot and analyze nonconforming data. Completion of thorough investigations to ensure that potential problems and root causes are identified, impact assessed and actions to prevent recurrence are considered and implemented.Perform internal audits and GEMBA walk-throughs of laboratory areas to maintain complianceCommunicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedulePerform viable and non-viable environmental monitoring in support of Manufacturing and Quality Control in the form of air testing, surface testing, personnel testing and particulate monitoring, inside the aseptic clean rooms, as necessaryOversight of critical processing steps performed by Manufacturing during aseptic product manufacture, ensuring accuracy of steps performedTraining of other employees as necessary

Qualifications

BASIC MINIMUM REQUIREMENTS:

BS in a related scientific disciplineAt least 4 years of microbiology experience in a GMP biologics or pharmaceutical environmentExperience with BacT rapid sterility assay, endotoxin testing, growth promotion, aseptic process media fills, and environmental monitoring required. Experience with cell therapy preferred.Knowledge of Current Good Manufacturing Practice, Good Documentation Practices, and Industry standards requiredExperience in aseptic processing and mammalian cell culture productionFamiliarity of basic laboratory equipment such as microscopes, pH meters, incubatorsExcellent verbal and written skills with good interpersonal communication skillsMust be open to occasional off shift and weekend work

Additional Information

Position is Full Time, Monday – Friday First Shift with support outside of standard hours. Although a remote position, candidates currently living within a commutable distance of Exton, PA are encouraged to apply.

What we offer:

Excellent full time benefits including comprehensive medical coverage, dental, and vision optionsLife and disability insurance401(k) with company matchPaid vacation and holidaysYearly goal-based bonus & eligibility for merit-based increases

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