Job Description
The Scientist II performs microbiology method development, method optimization and test method validations/verifications, applies scientific principles, methods and techniques to perform microbiological analyses, optimizes current microbiology methods and processes; supports cross-functional teams, performs equipment qualification, and identifies/leads laboratory projects. Adherence to standard operating procedures (SOP), safety guidelines, and compliance with current Good Manufacturing Practices (cGMP) and United States Pharmacopeia regulations is required in this highly regulated work environment.
Essential Duties & Responsibilities
- Perform microbiological analyses to support laboratory functions such as total aerobic microbial count test method validation, bacterial endotoxin test method verifications and validations, and other test methods as needed for raw materials, commodities, etc.
- Performs method development/optimization and/or verification/validation of microbial test methods.
- Write and execute qualification/verification/validation/stability study protocols and write summary reports detailing study findings.
- Write, troubleshoot and/or modify test methods, as required.
- Train new analysts in daily operations, workflow, and methods (both theory and practice).
- Investigate inconsistent results and propose possible causes and solutions, including documentation of the investigation via applicable laboratory investigation / exception report documentation.
- Oversees, performs and/or coordinates equipment qualifications and maintains laboratory instruments in their qualified state as well as troubleshoots instrumentation in the event of instrument issues.
- Work with vendors to evaluate instruments and assays and assist in making decisions involving future purchases based on needs and costs.
- Work with Biological Quality Laboratory on methods development, method transfer studies, and cross check studies.
- Set daily and weekly short-term goals to ensure timely completion of projects.
- Adhere to cGMP, USP, SOP, and plant policies/guidelines.
- Produce clear, consistent written documentation of data to support development studies, occasional routine testing, regulatory filings, or stability reports.
- Will be cross-trained to work in other laboratory areas as dictated by the needs of the organization.
- Coordinate the schedules and duties of the team in the supervisor’s absence.
- Assist site technical teams to troubleshoot microbiological issues.
- Perform other duties as assigned.
Knowledge, Skills & Qualifications
- A strong knowledge of microbiology techniques is required. Strong understanding of compliance with applicable laboratory and safety procedures is required.
- Professional experience in a GxP-regulated industry and understanding of cGMP, FDA, and ISO guidelines is required.
- Detail-oriented with the ability to multitask and prioritize tasks to meet deadlines.
- Demonstrated ability to use logic and reasoning to solve problems.
- Skilled in using computer software, and familiarity with validated computerized systems is preferred.
- Professional attitude emphasizing teamwork and cooperation.
- Must be self-directed, have strong critical thinking and problem-solving skills, and have participated in and successfully completed projects, demonstrating good communication, writing skills, and organizational and time management skills while maintaining a focus on quality.
- Must have familiarity with and technical writing capability for method development, verifications, validations, as well as USP and ISO guidelines.
- Must be able to provide general guidance to other analysts on a day-to-day basis.
- Must follow organized thought processes and have the visual acuity to accurately complete the extensive necessary documentation, plus a thorough understanding of the microbiology and theory involved.
- Capable of operating instrumentation with limited supervision.
- Must be able to apply standard scientific principles, methods and techniques to trouble-shoot and resolve common testing problems and technical service requests.
- Must be able to resolve routine testing and quality problems with limited assistance and supervision.
- Must be able to use mathematics to solve routine problems.
- Must be self-directed and demonstrate good organizational and time management skills.
- Must possess good communication and writing skills and be able to work effectively in cross-functional teams with all levels of individuals within the organization.
- Must be able to perform tests quickly and efficiently without sacrificing accuracy, safety or quality.
Education And Experience
- Degree in Microbiology, Biology, or Molecular Biology required (other science degrees will also be considered).
- BS in Microbiology, Biology, or Molecular Biology with 5+ years recent microbiological experience in a cGMP or FDA-regulated environment; or a MS degree in Microbiology, Biology, or Molecular Biology with 3-4+ year’s recent microbiological experience in a cGMP or FDA-regulated environment. PhD in Microbiology, Biology, or Molecular Biology with 2+ year’s recent microbiological experience in a cGMP or FDA-regulated environment.
Minimum Qualifications
- Must be at least 18 years of age
Travel Requirements
- Typically requires travel less than 5% of the time
Physical Requirements And Work Environment
- Office and laboratory environment. Frequent exposure to hazardous chemicals and microorganisms, the numerous methodologies that are required to test product, and the time constraints under which the work is accomplished.
- Ability to work night, weekend and holiday hours as required by projects and by support for 24/7 operation.
About Us
ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.
With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.
We're Ready To Bring You Consistent Quality, Innovation, And Value In More Areas Than Ever. Our Focus Allows Us To Bring You
- Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
- The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
- IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
- Significant US IV solutions manufacturing and supply capabilities.
ICU Medical EEO Statement:
ICU Medical is committed to fostering a diverse, inclusive, and equitable work environment. As an Affirmative Action and Equal Opportunity Employer, we ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender identity, gender expression, gender reassignment, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.
If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.
ICU Medical EEO Policy Statement
OFCCP Equal Opportunity Posters
“Know Your Rights” Poster
Pay Transparency Nondiscrimination Provision
ICU Medical CCPA Notice to Job Applicants
