Microbiologist

Open 30d

Summary

Performs routine microbiological testing and environmental monitoring for a pharmaceutical manufacturer, ensuring compliance with FDA and EU regulations in a non-remote role based in Bend, Oregon.

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 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

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What this application asks

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Resume/CV, Full name, Email, Phone, Current location, Current company

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Without providing dates of enrollment, can you confirm that you have completed the necessary education requirements of the position? yes / no · optional
Are you able to perform the essential functions of this job without reasonable accommodations? Note: We comply with the ADA and consider reasonable accommodation measures that may be necessary for qualified applicants/employees to perform essential job functions. choose one
As of this date, can you present evidence of your identity and legal right to work in this country? choose one
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I certify that all statements made in connection with this application (whether contained herein (and/or any supplements) or made by me or others at my request during the course of the employment process) are true and complete in al respects. I acknowledge and agree that any incorrect, incomplete, false, fraudulent, or misleading statements made by me, either verbally or in writing, and/or any omission, concealment, or failure or answer any question fully, completely, and accurately, whether made by me or others at my request, will result in rejection of this application, denial of employment, or termination from employment if discovered after employment. choose one
I authorize the investigation of all matters which Serán deems relevant to my qualifications for employment, including, without limitation, work records, reference checks, education, and an investigation into my driving record. I authorize and request that all my present and former employers, references, educational institutions, and any others to furnish and release information about me, my employment record, and/or education, including a statement of reason for the termination of my employment and information regarding my work performance, disciplinary reports or actions, abilities, degrees obtained, transcripts, licenses and certifications, and other qualities and information Serán deems pertinent to my qualifications for employment. I release Serán (and all providers of information) from all claims and/or liabilities arising out of or in any way connected with Serán's background investigation. If employed, I release Serán from any claims and/or liabilites for future references it may provide regarding my work history and performance with Serán. choose one
I understand that if offered employment, I will be required to submit proof of my identity and legal right to work in the United States as a condition of employment. choose one
I understand that any job offer may be contingent on me successfully passing a criminal background check/investigation. I release Serán from all claims and/or liabilities resulting from or related to the criminal background check/investigation. choose one
I understand that any job offer may be contingent on me successfully passing a pre-employment drug screen. I agree to hold harmless and release Serán and its agents from all claims and/or liabilities resulting in whole or part out of the collection of specimens, testing and the appropriate use of the information from such testing. choose one
I understand that, if employed, my employment relationship with Serán will be at-will. Therefore, subject to applicable law, my employment may be terminated (and I may voluntarily resign) at any time, for any reason or no reason, with or without cause or prior notice. Nothing contained in this application, or provided in connection herewith, will be construed as an offer or promise of employment, nor does this application create any employment contract or guarantee that employment or any benefit will be provided or continued for any period of time. choose one
Are you subject to any restrictions related to potential employment with Serán? Restrictions include noncompetition, nonsolicitation, no hire, or confidentiality. If yes, please provide an explanation (include name of company and description of restriction without disclosing any confidential or proprietary information to Serán)