Microbiologist-Sterilization in Irvine, CA at Apex Life Sciences

Date Posted: 6/4/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Irvine, CA
  • Job Type:
    Science
  • Experience:
    Not Specified
  • Date Posted:
    6/4/2018
  • Job ID:
    838682

Job Description


Seeking a microbiologist for a medical device company in Irvine, CA. This is a 6 month contract role. Must have knowledge of ethylene oxide sterilization. All qualified applicants should send their up-to-date resumes to jhambrose@apexlifesciences.com

POSITION DESCRIPTION:

This position has the responsibility and authority to provide scientific support for microbiological evaluation of medical devices, processes, and materials. The position will assist with sterilization validation(s) and cleanroom microbiological evaluations. The position provides technical guidance to engineers and/or project management. This position requires knowledge of Ethylene Oxide Sterilization per ISO 11135 and the Microbiologist should have strong report writing skills.

POSITION RESPONSIBILITIES:

  • Manages the sterilization, and microbiological testing necessary to meet manufacturing and regulatory requirements.
  • Responsible for maintaining compliance to all regulations and standards relevant to job responsibilities.
  • Manage technical projects from protocol development, laboratory testing, data analysis, through final report generation.
  • Manage environmental trending as required by regulations to ensure compliance for critical systems.
  • Perform various microbiological or chemical evaluations encompassing USP/AAMI biological testing, ETO residuals, gamma sterilization dose audits, and other alternate sterilization methods.
  • Provides technical support for new product development and manufacturing processes related to microbiological quality.
  • Meets and occasionally exceeds the duties and responsibilities of the job and of the Medtronic Core Competencies.
  • All activities must be performed in compliance with the Quality System.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
  • Knowledge of Ethylene Oxide Sterilization per ISO 11135.
  • This included validations, requalifications, and routine production
  • Travel requirement: Less than 10%

BASIC QUALIFICATIONS:

  • Bachelor of Science degree required.
  • Masters degree in Microbiology or other life sciences is preferred.

REQUIRED YEARS OF EXPERIENCE:

  • 2+ years of medical device industry experience.

REQUIRED KNOWLEDGE:

  • Basic math, general and analytical chemistry knowledge
  • Microbiology laboratory skills

DESIRED/PREFERRED QUALIFICATIONS:

  • Masters of Science in Microbiology or equivalent is preferred.
  • Knowledge of industrial microbiology, microbiological quality control, medical device sterilization methods, and medical device GMPs.
  • Knowledge of applied microbiological theory and practices including inactivation kinetics and medical device sterilization methods.
  • Microbiology laboratory skills including volumetric measurement, media preparation, microbial enumeration techniques, autoclave operation, and laboratory safety.
  • Basic math, algebraic math, with ability to calculate serial dilutions, scientific exponents, proportional concentrations, and graphing skills.
  • Knowledge of Cleanroom environmental monitoring.
  • Computer skills
  • Good oral and written communication skills.
  • Cross-functionally and an effective team player.
  • Ability to work in a team environment and exert influence without alienating others.
  • Excellent problem solving, analytical, and written communication skills.
  • Good computer skills using Excel, Word, and PowerPoint.