The Role
Support QC environmental monitoring and microbiology testing for pharmaceutical manufacturing: perform viable/non-viable and utility testing, cleaning verification, trend data analysis, write protocols/reports/investigations/CAPAs, maintain lab practices and cGMP compliance, coordinate sampling, and participate in continuous improvement and cross-functional initiatives.
Summary Generated by Built In
The 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 Responsibilities
- Conducts routine environmental monitoring sampling and testing including viable air, viable surface, and non-viable particulate testing in non-sterile and aseptic processing environments
- Conducts 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 strategy
- Collects equipment swab samples in the manufacturing environment to support cleaning process verification testing
- Trends environmental monitoring data and writes environmental monitoring trend reports
- Writes microbiological testing protocols and conducts microbiological testing to support manufacturing qualification activities
- Authors Incident Reports, laboratory investigations, Change Controls, and CAPAs
- May represent EM/Micro as an SME in support of cross-functional initiatives
- Maintains laboratory cleanliness and organization through routine disinfection of laboratory surfaces and equipment, inventory management, and participation in 5S activities
- Coordinates with members of other departments to schedule sampling events and ensures timely communication of test results
- Logs samples and standards into the QC Laboratory
- Adheres to Standard Operating Procedures, cGMPs, Quality Manual, and company policies
- Identifies opportunities for improvement and takes initiative to lead improvement efforts
- Adjusts work schedule when necessary to meet testing needs
- Performs other related duties as assigned
- Responsibilities may increase in scope to align with company initiatives
Required Skills and Abilities
- Strong verbal and written communication skills
- Strong analytical and problem-solving skills
- Demonstrated ability to collaborate and work in cross-functional teams
- Excellent organizational skills and attention to detail
- Strong time management skills with a proven ability to meet deadlines
- Ability to prioritize tasks and to facilitate delegation of tasks when appropriate
- Ability to function well in a high-paced and dynamic environment
- Accepts feedback from a variety of sources and constructively manages conflict
- Proficient with Microsoft Office Suite or related software
Education and Experience
- Bachelor’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 Requirements
- Prolonged periods of sitting or standing while monitoring equipment, analyzing data, or working on a computer
- Must be able to lift up to 25 pounds regularly
- Must be able to wear a Tyvek suit with PAPR for extended periods of time
- Exposure to constant low-level equipment noise, and occasional high-level alarms
- Work near heat generating equipment
- Move up and down ladders, kneel, squat, balance on one foot
- Adheres to consistent and predictable in-person attendance
Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.
Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
Skills Required
- Bachelor's degree in a scientific discipline (microbiology preferred).
- 1 year performing environmental monitoring testing and/or microbiological testing in a manufacturing environment (Scientist I).
- 2 years GMP experience required for Scientist II; 3-5 years preferred performing environmental monitoring and/or microbiological testing.
- Experience conducting viable air, viable surface, and non-viable particulate environmental monitoring sampling and testing.
- Experience testing utilities including high purity water systems (TOC, conductivity, endotoxin, bioburden) and compressed gas systems.
- Experience with growth promotion testing, cleaning process verification, and equipment swab sampling.
- Ability to write microbiological testing protocols, environmental monitoring trend reports, and laboratory investigations.
- Ability to author Incident Reports, Change Controls, and CAPAs and support manufacturing qualification activities.
- Proficient with Microsoft Office Suite or related software.
- Strong verbal and written communication, analytical, problem-solving, organizational, and time-management skills.
- Ability to collaborate cross-functionally, accept feedback, and manage conflict constructively.
- Adhere to Standard Operating Procedures, cGMPs, Quality Manual, and company policies.
- Maintain laboratory cleanliness, inventory management, and participate in 5S activities.
- Physical: lift up to 25 pounds, prolonged sitting/standing, climb ladders, kneel, squat, balance.
- Must be able to wear a Tyvek suit with PAPR for extended periods.
- Authorized to work in the U.S.; employer cannot sponsor or transfer employment visas.
- Preference given to candidates with regulatory knowledge and pharmaceutical manufacturing experience.
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The Company
What We Do
Serán Bioscience is a contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical support for small and large molecule drug development. They offer services ranging from discovery to clinical manufacturing, including formulation design, spray drying, and analytical quality control, with a science-first approach aimed at helping clients advance medicines to the clinic efficiently.
