Environmental Compliance and Microbiology Technical Specialist

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThe Environmental Compliance (EC) and Microbiology Technical Specialist will be located in St. Louis MO and work between the Brentwood MO and Bridgeton MO facilities to support activities. Standard working hours are 0800-1630 Monday through Friday but may require support outside of those hours as EC and Microbiology Technical Specialist is a position responsible for providing site-wide expertise and oversite for microbiology compliance data review environmental monitoring (EM) water monitoring programs laboratory investigations data integrity contamination control inspection readiness and quality systems within a fast-paced CDMO biopharmaceutical manufacturing ResponsibilitiesThis role serves as a technical expert and strategic partner for microbiological quality systems and compliance activities across the QC organization. They will assist in investigations CAPA development EM oversight trend review and analysis computerized laboratory system reviews and regulatory inspection EC and Microbiology Tech Specialist is responsible for ensuring that microbiological and environmental monitoring programs remain within a state of control are scientifically sound risk-based compliant with global regulatory expectations and aligned with company quality position serves as a subject matter expert for EM contamination control water monitoring systems media fill programs and Environmental Monitoring Performance Qualifications (EMPQ) activities. The role provides technical expertise to support the environmental compliance and microbiology OversightServe as a site SME for microbiological compliance environmental monitoring contamination control and microbiological quality continuous improvement initiatives to strengthen QC quality systems compliance and operational as a technical advisor to QC leadership for quality compliance and technical Review and Data IntegrityPerform and/or oversee technical review of microbiology and EM data as compliance with: cGMP requirements Data integrity requirements ALCOA principles and Good Documentation Practices (GDP)Evaluate raw data electronic records metadata audit trails and laboratory documentation as data integrity remediation activities and risk and Digital Quality SystemsServe as QC SME for MODA Environmental Monitoring program and workflows to improve operation automation efficiency and validation documents associated with MODA implementation and lifecycle computerized system validation activities and periodic Monitoring Water System and Aseptic Process Qualification OversightProvide technical oversite of the EM Review or Approve EM trend reports and utility EM investigations and corrective environmental monitoring data for adverse trends shifts or emerging water system excursion investigations and related opportunities to strengthen contamination control strategies and monitoring and approve media fill protocols reports risk assessments and associated microbiological/EM as an SME during media fill and EMPQ planning execution investigations and regulatory investigations associated with media fill failures interventions EM excursions and other aseptic qualification cross-functionally to ensure successful execution of media fill and EMPQ and qualify EM personnel on media fill and EMPQ sampling techniques aseptic practices documentation requirements and contamination control Review and TrendingReview microbiological and environmental monitoring trends for: Facilities Utilities Cleanrooms Water systems and Manufacturing data for scientific plausibility and compliance recurring issues and emerging trends that may impact product quality or patient with developing recommendations based on trend analysis and risk LeadershipLead and support complex investigations involving:EM excursionsWater system excursionsOOS OOT OOEDeviationsContamination eventsData integrity concernsLaboratory investigationsAssist with root cause analysis using scientific and risk-based additional testing monitoring or investigative actions when investigations are timely scientifically justified and compliant with regulatory with QA and functional departments to drive closure of quality and Effectiveness ProgramAssist with development and review of Corrective and Preventative Actions (CAPAs).Evaluate Capa adequacy and CAPA effectiveness checks and recurrence trends and identify opportunities for systemic Readiness and Regulatory SupportServe and an SME as needed during customer audits and regulatory FDA EMA MHRA and other health authority or support associated responses to regulatory observations and microbiology and environmental monitoring programs remain inspection-ready at all Skills and QualificationsBachelors Degree in Microbiology Biology Biotechnology Pharmaceutical Sciences Biochemistry or related scientific discipline.3-5 years of pharmaceutical biotechnology or CDMO experience in Quality Control Microbiology Environmental Monitoring Quality Systems or related in complex investigations and CAPAs or Change supporting inspections audits and associated supporting sterile parenteral with computerized environmental monitoring systems and validation KnowledgeEnvironmental monitoring programsAseptic ManufacturingUtility and water system monitoringContamination Control strategiesMedia qualificationMicrobial IdentificationEndotoxin TestingBioburden TestingSterility TestingMethod Validation and VerificationQuality SystemscGMP regulationsData integrityALCOAGood Documentation Practices (GDP)OOS/OOT/OOE InvestigationsDeviationsCAPA SystemsChange ControlRisk ManagementInspection readiness programsDigital SystemsMODA Environmental Monitoring Systems (or similar)LIMSElectronic Quality SystemsAudit Trail ReviewComputerized System Validation (CSV)CompetencyExceptional scientific and technical attention to to recognize scientifically implausible results and data technical to assess risk and make sound and root cause analysis written and verbal communication to recognize compliance risks and implement sustainable ability to collaborate effectively across functions and organization analytical critical thinking and decision-making We OfferCompetitive base salary performance bonusComprehensive benefits package (health dental vision 401k etc.)Structured mentorship and professional development programsExposure to cutting-edge pharmaceutical manufacturing technologiesClear career progression path toward Senior Manufacturing Engineer rolesCollaborative and supportive work culture#LI-Onsite