Environmental Monitoring SME – QC Microbiology

Title: Environmental Monitoring SME – QC Microbiology Location: Portsmouth, NH (Onsite) Employment Type: Fulltime / Permanent Status: Accepting CandidatesAbout the roleJoin a quality-focused manufacturing environment as a senior technical leader supporting the Environmental Monitoring program. This role will drive microbial control strategy, lead complex investigations, support regulatory readiness, and mentor QC teams in a cGMP setting.Key ResponsibilitiesServe as the technical SME for Environmental Monitoring and utility monitoring programsLead complex environmental excursion investigations using root cause analysis (RCA) and drive effective CAPA implementationPerform advanced trending and analysis of environmental and utility data to identify contamination risks and long-term trendsSupport internal and external regulatory inspections, including audit defense for EM procedures and dataReview and approve laboratory records, validation protocols, and technical reportsMentor junior analysts and support continuous improvement initiatives across the QC microbiology functionQualificationsBachelor’s degree in Microbiology, Biology, or Life Sciences5–10 years of experience in QC Microbiology or Environmental Monitoring within a cGMP manufacturing environmentStrong expertise in cleanroom classifications (Grade A–D) and aseptic processingDeep understanding of FDA, EMA, ICH, and current global regulatory expectationsExperience with LIMS, data trending tools, and technical documentation reviewProven ability to lead cross-functional projects and communicate scientific findings to leadership and auditors