Validation Engineer I in South San Francisco, CA at Apex Life Sciences

Date Posted: 8/8/2018

Job Snapshot

Job Description


Apex Life Sciences is looking to hire a Validation Engineer with a large biotech company in the South San Francisco area. Below is the abbreviated version.

Duties: 

  • This entry level position is for a Validation Contractor for the Validation Engineering group in South San Francisco Production (SSFP).
  • The candidate will be responsible for supporting validation activities.
  • This includes supporting Periodic Reviews of validated equipment in SSFP, which entails review of change records for validation impact, through the TrackWise system.
  • The Periodic Review will also include review of monitoring data trends and validation lifecycle documents.
  • These reviews will be compiled in a Periodic Review summary report.
  • The contractor may support revalidation execution on equipment to ensure the equipment has been operating in a validated state, Cleaning Validation activities, New Product Introduction (NPI), and qualification of changes to GMP equipment.
  • Activities may include but are not limited to protocol generation, execution of protocols, swab and rinse water sampling, data analysis, reviewing worksheets, obtaining batch records and QC results, and summary report authoring.
  • The contractor will be expected to work effectively with customers (System Owner and Technical SME and Quality) to complete these validation activities.
  • Contractor must follow all safe work practices including use of appropriate Personal Protective Equipment and ensure training is up to date.

Skills: 

  • The candidate must be highly self-motivated, have excellent organization and communication skills, be willing and able to work independently or as part of a multi-disciplinary team.
  • Attention to detail is essential for a successful candidate.
  • Experience in a GMP regulated environment and use of quality systems and processes such as change control and discrepancy / deviation processes is desirable, but not required.

Education: A B.S. or higher in Engineering or Science discipline with 0-3 years of relevant experience.

If you are interested, please send your resume to awoods@apexlifesciences.com

Hours Per Day: 8.00

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.