Microbiologist II
POSITION OVERVIEW:The Microbiologist II plays a key role in advancing microbiological quality by performing complex testing, supporting method development and validation, and leading critical investigations to ensure regulatory compliance and product integrity. This position may also mentor junior team members, oversee aspects of environmental monitoring, and contribute to continuous improvement across laboratory operations. Through scientific excellence and operational leadership, the Microbiologist II directly supports our mission to expand access to affordable, innovative medications that are safe, effective, and life-enhancing.ESSENTIAL JOB FUNCTIONS:Conducts microbiological sampling and testing of raw materials, finished products, and environmental monitoring samples using methods such as bioburden, sterility, endotoxin, and total organic carbon, while adhering to International Organization for Standardization cleanroom protocols involving gowning and routine sample handlingLeads or actively contributes to laboratory investigations, including growth promotion, microbial enumeration, identification, antimicrobial effectiveness testing, root cause analysis, and impact assessments for Out of Specification or Out of Trend results, and proposes or implements effective corrective and preventive actionsSupports or executes the development, validation, and transfer of microbiological test methods, including protocol drafting, execution, and data interpretation in collaboration with Quality Control and Research & Development teamsAccurately documents procedures, results, and observations in compliance with laboratory protocols, safety guidelines, and regulatory standards, including current Good Manufacturing Practices (cGMP), while supporting data trending, change control documentation, and maintaining laboratory equipmentCollaborates across functions and mentors junior staff as needed, communicating technical findings clearly and participating in research discussions, project meetings, and continuous improvement initiativesQUALIFICATIONS:Minimum of 3 years of microbiology experience in a regulated laboratory setting is required; pharmaceutical, compounding, or aseptic experience strongly preferredBachelor’s degree in microbiology, biology, biochemistry, or a related scientific field required; advanced coursework or relevant certifications preferredProficiency in microbiological testing techniques, method development and validation, and environmental monitoring, with working knowledge of compendial methods, bacterial endotoxin testing, sterility, microbial limit testing, and regulatory standards including United States Pharmacopeia, Food and Drug Administration, and cGMPStrong analytical and problem-solving skills, with the ability to work independently and collaboratively, prioritize evolving workloads, and communicate effectively in both written and verbal formatsKEY COMPETENCIES:Customer Focus: Ability to build strong customer relationships and deliver customer centric solutionsOptimizes Work Processes: Know the most effective and efficient processes to get things done, with a focus on continuous improvementCollaborates: Builds partnerships and works collaboratively with others to meet shared objectivesResourcefulness: Secures and deploys resources effectively and efficientlyManages Complexity: Makes sense of complex, high quality, and sometimes contradictory information to effectively solve problemsEnsures Accountability: Holds self and other accountable to meet commitmentSituational Adaptability: Adapts approach and demeanor in real time to match shifting demands of different situationsCommunicates Effectively: Develops and delivers multi-mode communications that convey a clear understanding of the unique needs of different audiencesVALUES:People: Our people define who we are as a company, and we believe that understanding and addressing the needs of our team, clients, and community is fundamental to fostering a culture of support and growthQuality: Quality stands at the core of our mission, reflecting our commitment to excellence in every medication we produceService: We are here to serve others. Every interaction with our patients, providers, employees, and other stakeholders comes from a place of serviceInnovation: By continuously exploring new methodologies and embracing technology, we ensure that every solution we offer is at the forefront of pharmaceutical careSUPERVISORY RESPONSIBILITIES:This position does not have supervisory responsibilities.CERTIFICATES, LICENSES, REGISTRATIONS:Registered Microbiologist (RM) through the National Registry of Certified Microbiologists preferred; Certified Quality Auditor (CQA) through the American Society for Quality preferred;Other industry-recognized microbiology or quality certifications are considered a plus.Important Notice: Protecting Your InformationMedvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to jobs@medvacon.com.Powered by JazzHRq8Mrj7h2Dz