Sr Microbiologist - Sterilization in Goleta, CA at Apex Life Sciences

Date Posted: 2/11/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Goleta, CA
  • Job Type:
    Science
  • Experience:
    At least 5 year(s)
  • Date Posted:
    2/11/2018
  • Job ID:
    813260

Job Description


Apex Life Sciences is searching for an experienced Senior Sterilization Microbiologist experienced in validation to work an assignment at a well-known medical device company in the Santa Barbara area!

Description:

  • This position has the responsibility and authority to, under limited supervision, administer sterilization adoptions and validations. 
  • Incumbent administers the environmental monitoring program, including bioburden, bacterial endotoxin, sterilent residues, and clean room certification.
  • Incumbent produces sterilization protocols and reports, compliant with internal requirements and applicable standards. 
  • Performs all activities within the Quality System.

Responsibilities:

  • Ensures effective analysis and reporting of sterilization data. Including the development strategies to address problematic test observations and deficiencies.
  • Compiles and analyzes trend data appropriate for continuous improvement and monitoring of product and clean room bioburden levels.
  • Writes sterilization protocols, reports, and adoptions appropriate for products in compliance with the current regulations.
  • As a team member, coordinates project activities for new product and product revision designs to analyze possible impacts on sterilization properties.
  • Manages sterilization and environmental monitoring testing including preparing test samples, scheduling, coordinating with outside facilities, planning and purchasing as needed.
  • Authors technical documents that effectively interpret and present data, and provide appropriate rationale to support conclusions regarding sterilization and environmental controls.
  • Provides input to QC and Manufacturing regarding product sterility levels and provides feedback to manufacturing to ensure basic understanding of the possible causes of sterility testing / monitoring discrepancies.
  • Performs internal assessments on documents and practices to ensure continuing compliance with current standards for medical device manufacturing regulations and Company SOP’s as related to product sterility and controlled area environmental controls.
  • Determines corrective action and performs re-assessments in response to sterilization or environmental issues and planned changes.
  • Assists other engineers, QC, Specials and Manufacturing in developing sterilization specifications .
  • Remains informed about current standards, regulations, engineering and material trends regarding sterilization and environmental control by reviewing current literature for technological application, and appropriate coursework.
  • Assists in setting specifications. 
  • Works with experimental data and math models to establish specifications, as assigned.
  • Researches ideas for improvements to SOPs to improve compliance, streamline operations, and/or save cost.
  • Reviews appropriate technical literature for necessary background on specific assignments.
  • Performs duties in compliance with the Quality System.
  • Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
  • Other duties as assigned by Supervisor.

Qualifications:

  • BS in Microbiology preferred.
  • 5+ years of related laboratory experience
  • Strong verbal communication.  Ability to present technical information to various levels of management in a manner that is easily understood.
  • Strong written communication skills including ability to write protocols and reports for engineering approval.
  • Very good math & analytical skills.
  • Very good working knowledge of statistics.
  • Very good problem solving skills.
  • Very good organizational skills
  • Ability to apply detailed product or process knowledge to solve problems.
  • Ability to apply the scientific method.
  • Very good troubleshooting skills on equipment or processes.
  • Strong interpersonal skills, demonstrated ability to interface on project teams as an effective team member
  • Demonstrated ability to coordinate complex activities
  • Proficiency with personal computer software including word processing, spreadsheet, and statistical programs
  • Takes initiative in all areas of responsibility and anticipates needs and potential problems.
  • Ability to effectively train others.
  • Familiarity with Quality System requirements, including FDA GMPs, ISO 13485, and ISO 9000 and documentation procedures
  • Medical device industry experience
  • Ability to learn systems quickly

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.




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