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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.
The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organization 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 Organizations. It also has a rapidly developing presence in highly specialized 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 decentralized 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.
Job Description
About the job
This role is for an Environmental Monitoring Technician that will perform testing work at both the Eurofins Infinity Laboratories San Diego location and at Client sites, including air travel (10-20%).
Your Role:
The Environmental Monitoring Technician performs environmental monitoring and routine microbiological testing within a GMP biopharmaceutical manufacturing organization.
• Performs routine and non-routine Environmental Monitoring (EM) such as water sampling, non-viable particulates, viable air, viable surfaces, and gas testing in cleanroom environments within the Manufacturing area at Client's site, as per applicable standard operating procedures (SOP).
• Perform environmental monitoring for aseptic filling processes according to SOP.
• Operate monitoring equipment that includes but is not limited to Laser Particle Counter, Viable Air Sampler, Microscope, MilliFlex OasisTest System, Conductivity meter, pH meter and TOC analyzer.
• Read EM (Environmental Monitoring) data and document results on relevant forms.
• Perform trending and generate trending charts for EM data.
• Participate in validation/verification of controlled environments such as cleanroom, and gowning qualification.
• Perform Quality Control testing such as media and organism qualification as per applicable procedures.
• Assist in USP standard testing including but not limited to water sampling, incubation of samples, and enumeration.
• In cooperation with the Laboratory Manager, responsible for the preventative maintenance of critical EM equipment.
• Monitor test status and conditions as described in Work Instructions and SOPs.
• Record test results accurately and legibly on all documents.
• Technical report writing including text, tables, graphs, and diagrams.
• Report any deviations and/or nonconformities to Management as well as provide possible preventive and corrective measures to prevent future deviations and non-conformities.
• Assist with OOS, NI, CAPA, and Change Control processes in response to Laboratory issues.
• Follow and perform process qualifications and validations for procedures and/or equipment.
• Update procedures for improvement to methods.
• Able to lift at least 50 lbs.
• Assist in the training of new EM Laboratory Technicians.
• Perform bioburden testing of samples per USP, EP requirements.
• Perform Area Release per protocol for campaigned manufacturing areas.
• Comply with all safety policies, practices, and procedures.
• Participate in proactive team efforts to achieve departmental and company goals.
• Driving a company car for offsite work
• Perform other duties as assigned.
Qualifications
Minimum Qualifications:
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