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Analytical Systems Engineer in Thousand Oaks, CA at Apex Life Sciences

Date Posted: 11/27/2018

Job Snapshot

Job Description


Responsibilities:

  • Responsible for the maintenance, ownership, and validation of the benchtop analytical systems in the GMP Clinical and Commercial Manufacturing Facility..
  • These off-the-shelf analytical instruments include TOC, cell counter, gas, particle counter, and metabolite analyzers.
  • The maintenance responsibilities includes performing hands-on preventive maintenance, trouble shooting, and corrective maintenance on the floor in the plant.
  • This will also include managing the vendors of the instruments and bringing them in-house to perform more extensive maintenance activities.
  • The ownership responsibilities include reviewing and improving both procedures and maintenance job plans, supporting investigations, using Maximo, and improving the overall reliability of the instruments.
  • The validation responsibilities include performing hands-on commissioning and qualification testing, reviewing testing protocols, and reviewing and approving reports generated by our validation partners. In summary, the system owner is accountable for ensuring these instruments are operational, compliant, and reliable. 

Qualifications:

  • BS Degree in STEM
  • The candidate must have an extensive experience using bench top analytical instruments, developing methods, and solving issues using science based approaches.
  • In addition, the candidate must have a proven history of working in a GMP environment complying with Good Documentation Practices and partnering with Quality Assurance.
  • This individual must be able to work independently, prioritize tasks, and communicate progress and issues regularly and efficiently.
  • The candidate’s performance will be measured by their ability to work independently, comply with procedural requirements, and improve the reliability of these systems. 
  • The preferred candidate will have experience with these instruments commonly used in cell culture manufacturing facilities and a history of working in a plant environment on the floor.

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 844-463-6178.




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