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EM Tech 2, Microbiology

Your Role

The Carlsbad Gene Therapy Viral Vector Manufacturing is a contract manufacturing site that produces drug substance and drug products for gene therapy and oncology applications

The EM Tech 2 will be responsible for supporting all aspects of microbiological assay and Environmental Monitoring activities to support client processes and manufacturing activities, ensuring compliance with the established SOPs, cGMP, and all regulatory agencies. He/she will need to embody the company vision and values. 

  • Ability to work successfully, strategically and tactically in a fast-paced, multi-disciplinary environment with potential for rapidly changing priorities.
  • Proven ability to obtain direction and commitment to ensure that projects are completed by deadlines and streamlining processes to maximize productivity.

 

Who You Are

Basic Qualifications:

  • BA/BS in scientific discipline and 2 or more years of relevant experience Microbiology/Environmental Monitoring
  • 2+years of experience in Quality Control and CMO environment
  • 2+ years of experience with cGMP, aseptic techniques, microbiology testing, Environmental Monitoring, automation, troubleshooting for machineries, equipment, software and data integrity.
  • 2+ years of experience in Lean Manufacturing and Continuous Improvement
  • 2+ years of experience in quality systems supporting ISO 9001 and 134585 certifications as well as FDA regulations (such as 21CFR11).
  • 2+ years of experience working with governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals as well as compendial methods.
  • 2+ years of technical experience in Microbiology and Environmental Monitoring fields. 

 

Preferred Qualifications:

  • Previous experience of utilizing and/ implementing electronic Microbiology/EM software (MODA or Novatek or equivalent) is required.
  • Excellent communication, organization, analytical and technical writing skills
  • Working knowledge of validations, calibration systems, process design, design of experiment, instrumentation, automation, and digitization/paperless system.
  • Operational knowledge of the regulation (cGMP, ISO, EMA) and directives, and liability for non-compliance.
  • Possess understanding of group dynamics and have the ability to effectively influence group decision-making process.
  • Ability to analyze past and current data and recommend objectives to improve productivity and increase efficiency.
  • Working knowledge of method development, qualification and validation and method transfer principals.
Job Requisition ID:  191787
Location:  Carlsbad
Career Level:  B - Recent University Graduate(<1 year of experien
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Microbiology, Oncology, QC, Testing, Science, Healthcare, Quality, Technology

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