CSV Engineer III

Employer
Bachem
Location
Torrance, CA, US
Posted
Nov 11, 2020
Ref
631842801
Hotbed
Biotech Beach
Required Education
Masters Degree/MBA
Position Type
Full time
The CSV Engineer (CSV Engineer III) fulfills a critical role in GMP operations, supporting computer system validation activities for API and PMO manufacturing, for computerized system attached to equipment, facilities, utilities. This position will work in close cooperation with Manufacturing, Engineering, and other functional areas to plan and perform CSV activities under the Quality Engineering scope of work. This individual must also monitor facility / utility validated systems, plan, write and execute validation/ qualification protocols, reports, and other technical documents, as well as conduct related investigations.

Your Tasks:

  • Ensure compliance of relevant computer systems and applications with regulatory requirements and controls associated with CFR 21 Part 11 and EU GMP Annex 11
  • Development and maintenance of life cycle documents necessary to address the validation lifecycle (Risk assessments, validation plan, SOP, etc.)
  • Work directly with local and Central QA departments
  • Participate in site projects and manage all activities in regards to validation and qualification of computer systems and applications
  • Represent CSV implementation during regulatory inspections and partner audits and provide CSV related responses to inspectors/auditors


Your Profile:

  • Bachelors' degree in computer science, engineering or science discipline required
  • Minimum of 5 years of hands-on experience in computer system validation or in a quality control analytical laboratory in a GMP/GDP environment required, and in planning, writing and executing qualification protocols (IQ, OQ, PQ) and reports
  • Proven track record in validation and qualification of complex computer systems
  • Thorough knowledge of cGMP regulations related to CSV including CFR 21 Part 11, EU GMP Annex 11, GAMP, and data integrity standards
  • Experience with writing, reviewing and executing computer validation documentation (Validation plan, IQ, OQ, DQ, SOP, Specifications, Risk assessments)
  • Excellent written and oral communication skills
  • Excellent computer knowledge, including Microsoft Word, Excel and PowerPoint
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one's time
  • Communicate effectively and ability to function well in a team environment
  • Experience in a cGMP environment required
  • General lab instrumentation knowledge and operation experience
  • Capable of working methodically and accordingly adhering to rules and regulations.
  • Entering or recording information in written or electronic form
  • Using hands and arms in handling, installing, positioning, and moving materials, and manipulating things
  • Basic computer knowledge, including Microsoft Word, Excel, PowerPoint and Visio
  • Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
  • Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
  • Detail oriented with the ability to troubleshoot and resolve problems
  • Ability to work independently and manage one's time
  • Communicate effectively and ability to function well in a team environment.
  • Coach and mentor validation personnel as well as oversee the activities of contractors / vendors (as necessary)


Preferred:

  • Master's degree in science related field (computer science, engineering, science)
  • Experience with Equipment, Facility, and Utility System Qualification (IQ, OQ, PQ)
  • Experience with Lean Six Sigma methods: Root cause analysis, failure mode analysis and analyzing / organizing complex technical problems
  • Experience with audit/inspection presentations, and strong technical communication skills


Nearest Major Market: Los Angeles