Within this role you will perform testing to ensure cGMP compliance in the manufacturing facility. Responsible for assessing the microbiological quality of products, manufacturing equipment, manufacturing process areas, and facility utilities.Typical Day ResponsibilitiesEnter a laboratory cleanroom to collect and log samples for microbial analysisPerform bioburden and endotoxin sample analysis in accordance with SOPsPerform or support sample analysis for microbial identificationConduct environmental monitoring, including surface, settling, and viable/non‑viable particulate air monitoring of aseptic operations and controlled areasPerform acceptance testing of commercially prepared microbiological culture mediaAutoclave microbiological media and laboratory waste as neededEnsure all work complies with regulatory standards and company SOPsComplete own test records on time and peer‑review data from other analysts for accuracy and completenessAssist in the design, set‑up, and calibration of the QC microbiology laboratory and laboratory instrumentsParticipate in microbiological validations for drug substance, in‑process controls, buffers, and clean utilities qualification programsAssist manufacturing personnel in identifying microbiological root causes and provide technical adviceParticipate in the transfer of methodology from other test facilitiesMaintain laboratory reagents, media, and suppliesConduct laboratory investigations and generate reports in response to invalid assays, deviations, and OOS/OOT resultsInitiate and complete CAPAs and change controls in accordance with site proceduresWrite new and update current SOPs as neededProvide training to other analysts in the QC groupPresent analytical data reports clearly and concisely to managementProactively identify and implement lab process improvements and lean initiativesPerform other duties relevant to the QC laboratory position as requiredQualificationsBS/BA in Life Sciences or an equivalent qualification, or relevant experience may be considered in place of a degree requirementRelevant experience for levels beyond I (preferably in pharmaceutical or biotechnology industries)Associate QC Micro Analyst: Minimum 0–2 years’ experienceQC Micro Analyst: Minimum 2 years’ experienceBenefitsRegeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role:Annual bonuses or other incentive plansEquity awardsPension or retirement benefits, including 401(k) company matchHealth and wellness programs, fitness centers, insurance benefits (medical, dental, vision, life, and disability)Paid time off and family support benefitsSalarySalary Range (hourly): €16.42–€25.59Equal Opportunity StatementRegeneron is an equal‑opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief, sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
#J-18808-Ljbffr