Biology Jobs .com Life Science career site  
 
 


Laboratory Instrument Software Validation Engineer

Post Date:Dec 26, 2017Type:Contractor
Start Date:12/26/2017Salary:
Location:US-CA-South San Francisco, CA Job Reference:
Skills:

Duties:

The Equipment Qualification Engineer will be responsible for qualification of laboratory instruments used in development of drug-device combination products at the Client.  The candidate must have technical expertise in qualification and application of computerized laboratory instrumentation.  The candidate will provide hands-on planning and implementation of qualification laboratory instrumentation.  The candidate will be the point-of-contact for managing the interface of instrument suppliers, Information Technology (IT), Quality, and Device Development design engineers.

  • Qualify new and existing laboratory instruments.
  • Support installation and relocation activities when needed to ensure proper systems startup and recommend changes to improve system design.
  • Author commissioning and qualification documents. This includes deliverables such as Planning (Qualification Plan), Risk Assessments, System Requirements, Design Specifications, Design Qualification Protocols, Qualification Test Protocols (IQ/OQ/PQ), Final Reporting, and support documentation (i.e. SOP development, PMs, calibration, etc.).
  • Execute the qualification (IQ/OQ/PQ/CSV) of new and existing laboratory instruments.
  • Review laboratory requirements and update procedures for instrument management, instrument qualification (IQ/OQ/PQ), and data management.
  • Manage interactions as primary point-of-contact between instrument suppliers, Information Technology (IT), Quality, and Device Development design engineers.
  • Regularly interact with external development partners and equipment suppliers.
  • Comply with Roche Pharma Quality Policy and Pharma Quality System (PQS).
  • Core training is mandatory and must be completed within the allotted time frame beginning with on-board date.  Initial training requirements are listed in this section.  Additional training to enhance Core requirements may be assigned as elective courses.  These elective courses are deemed essential to performing the job duties related to this position.

Log onto CHRIS LSO to access training.


Skills:

Technical Knowledge:

  • Experience with laboratory instrument qualification (IQ/OQ/PQ).
  • Engineering: expertise in electrical/mechanical instrumentation, system engineering, process engineering, data acquisition.
  • Experience in the Pharmaceutical, Biotech or Medical Device industry is required.
  • Interpersonal Skills:
    • Proven track record of working effectively in a matrixed organization that interfaces with both internal and external groups.
    • Excellent oral and written communication skills are required
    • Highly organized and detail oriented

Self-starter that takes initiative and drives projects to completion

Education:

  • B.S, M.S, Ph.D or advanced degree in Science or Engineering, with preference for Mechanical Engineering, Electrical Engineering, or Chemical Engineering.
  • At least 5 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.


Job Description:

Duties:

The Equipment Qualification Engineer will be responsible for qualification of laboratory instruments used in development of drug-device combination products at the Client.  The candidate must have technical expertise in qualification and application of computerized laboratory instrumentation.  The candidate will provide hands-on planning and implementation of qualification laboratory instrumentation.  The candidate will be the point-of-contact for managing the interface of instrument suppliers, Information Technology (IT), Quality, and Device Development design engineers.

  • Qualify new and existing laboratory instruments.
  • Support installation and relocation activities when needed to ensure proper systems startup and recommend changes to improve system design.
  • Author commissioning and qualification documents. This includes deliverables such as Planning (Qualification Plan), Risk Assessments, System Requirements, Design Specifications, Design Qualification Protocols, Qualification Test Protocols (IQ/OQ/PQ), Final Reporting, and support documentation (i.e. SOP development, PMs, calibration, etc.).
  • Execute the qualification (IQ/OQ/PQ/CSV) of new and existing laboratory instruments.
  • Review laboratory requirements and update procedures for instrument management, instrument qualification (IQ/OQ/PQ), and data management.
  • Manage interactions as primary point-of-contact between instrument suppliers, Information Technology (IT), Quality, and Device Development design engineers.
  • Regularly interact with external development partners and equipment suppliers.
  • Comply with Roche Pharma Quality Policy and Pharma Quality System (PQS).
  • Core training is mandatory and must be completed within the allotted time frame beginning with on-board date.  Initial training requirements are listed in this section.  Additional training to enhance Core requirements may be assigned as elective courses.  These elective courses are deemed essential to performing the job duties related to this position.

Log onto CHRIS LSO to access training.


Skills:

Technical Knowledge:

  • Experience with laboratory instrument qualification (IQ/OQ/PQ).
  • Engineering: expertise in electrical/mechanical instrumentation, system engineering, process engineering, data acquisition.
  • Experience in the Pharmaceutical, Biotech or Medical Device industry is required.
  • Interpersonal Skills:
    • Proven track record of working effectively in a matrixed organization that interfaces with both internal and external groups.
    • Excellent oral and written communication skills are required
    • Highly organized and detail oriented

Self-starter that takes initiative and drives projects to completion

Education:

  • B.S, M.S, Ph.D or advanced degree in Science or Engineering, with preference for Mechanical Engineering, Electrical Engineering, or Chemical Engineering.
  • At least 5 years of experience in the industry and/or academia (including advanced studies) after receiving their Bachelors degree.




Contact Information

Name: Ali Naderi
Ph: +1(925)837.4040


Apply for this Job


 
Please help us spread the word about BiologyJobs.com by telling any organization you know that hires employees with a background in biology that they can advertise their open positions online at BiologyJobs.com for only $1 per day with unlimited job postings and resume database access plus their organization's profile and logo featured online. You can't beat the affordable advertising rates of Biology Jobs .com combined with the highly tartgeted traffic that your job postings will recieve compared to other online job board services.

Whether you are working on your degree, or your have completed your B.A. (bachelor of arts) B.S. ( bachelor of science ) M.S.( master of science ), M.A. ( master of arts ),or Ph.D ( doctorate of philosophy ) degree , and you are looking for a postdoctoral ( postdoc ) job, Biology Jobs .com has job openings posted online at various times for all levels of Biology Jobs from volunteer positions to postdoctoral research jobs to tenured professors, positions with top biotechnology companies and everything in between.