Microbiologist

Microbiologist PositionThe Quality Control Department is seeking a microbiologist to support the Environmental Monitoring and Microbiology program. This role supports manufacturing through performing routine monitoring testing, utility testing, and cleaning process verifications testing. Work performed must be in accordance with US-FDA, EU and other applicable regulations. Preference will be given to those with regulatory knowledge and experience in a pharmaceutical manufacturing environment. Those with a background in microbiology and environmental monitoring in an adjacent industry are encouraged to apply.Serán BioScience develops and manufactures novel drug products for a variety of pharmaceutical applications. We aim to build a workforce that is collaborative, creative, and kind. In addition to the skills required of the role, qualified candidates will approach their work with integrity and enthusiasm to promote a positive work culture. Employees are awarded generous PTO accrual, low-cost health benefits, and a 5% 401(k) contribution that does not require an employee match or vesting. Want to learn more about what we do, who we are, and how you can contribute? We look forward to seeing your application.Duties and ResponsibilitiesConducts routine environmental monitoring sampling and testing including viable air, viable surface, and non-viable particulate testing in non-sterile and aseptic processing environmentsConducts quality control testing of utilities including high purity water systems (TOC, Conductivity, Endotoxin, and Bioburden) and compressed gas systems (hydrocarbon, moisture, bioburden, non-viable particulates, et cetera)Conducts growth promotion testing and qualification testing to support environmental monitoring strategyCollects equipment swab samples in the manufacturing environment to support cleaning process verification testingTrends environmental monitoring data and writes environmental monitoring trend reportsWrites microbiological testing protocols and conducts microbiological testing to support manufacturing qualification activitiesAuthors Incident Reports, laboratory investigations, Change Controls, and CAPAsMay represent EM/Micro as an SME in support of cross-functional initiativesMaintains laboratory cleanliness and organization through routine disinfection of laboratory surfaces and equipment, inventory management, and participation in 5S activitiesCoordinates with members of other departments to schedule sampling events and ensures timely communication of test resultsLogs samples and standards into the QC LaboratoryAdheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policiesIdentifies opportunities for improvement and takes initiative to lead improvement effortsAdjusts work schedule when necessary to meet testing needsPerforms other related duties as assignedResponsibilities may increase in scope to align with company initiativesRequired Skills and AbilitiesStrong verbal and written communication skillsStrong analytical and problem-solving skillsDemonstrated ability to collaborate and work in cross-functional teamsExcellent organizational skills and attention to detailStrong time management skills with a proven ability to meet deadlinesAbility to prioritize tasks and to facilitate delegation of tasks when appropriateAbility to function well in a high-paced and dynamic environmentAccepts feedback from a variety of sources and constructively manages conflictProficient with Microsoft Office Suite or related softwareEducation and ExperienceBachelor's degree in scientific discipline. Degree in microbiology preferred.Scientist I requires 1 year performing environmental monitoring testing and/or microbiological testing in a manufacturing environment.Scientist II requires 2 years of GMP experience, 3-5 years preferred performing environmental monitoring testing and/or microbiological testing.Physical RequirementsProlonged periods of sitting or standing while monitoring equipment, analyzing data, or working on a computerMust be able to lift up to 25 pounds regularlyMust be able to wear a Tyvek suit with PAPR for extended periods of timeExposure to constant low-level equipment noise, and occasional high-level alarmsWork near heat generating equipmentMove up and down ladders, kneel, squat, balance on one footAdheres to consistent and predictable in-person attendanceThe Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701