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Validation Engineer Senior (JP7841)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title: Validation Engineer Senior (JP7841)
Location: Thousand Oaks, CA
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 26 October 2020
Note: Must be available to be onsite, M-F, with some remote work
 
3 Key Consulting is hiring a Validation Engineer Senior for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.
 
Job Summary:
  • Must be available to be onsite, M-F, with some remote work
  • 7+ years of Validation Engineer Experience (at least 5 years within Pharma or Biotech)
  • Bachelor’s degree - any science related, preference within computers & engineering
  • Must have software permissions experience & TOP MUST HAVE SKILLS*
  • Primarily responsible for ensuring adherence to computer validations, data integrity standards, and procedures for computer related analytical laboratory instruments.
  • Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries.
  • Provides guidance and sets standards in producing quality documentation, serves as the liaison between department, IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in issue resolution during installation and qualification activities.
  • Ability to effectively communicate and multitask.
 
Top Must have Skill Sets:
  • Experience with computer system validations including leading, developing and implementing validation strategies and authoring required validation documents.
  • Experience qualifying analytical laboratory instrumentation (eg HPLCs, Spectrophotometers, FTIRs, etc.)
  • Knowledge of cGMPs and data integrity requirements (21 CFR Part 210/211, Part 11) and analytical instrument qualification (USP 1058).
 
Day-To-Day Responsibilities:
  • Implement and coordinate the installation and qualification of laboratory equipment and computer systems (e.g. hardware, software, and accessory systems) for use in regulated operations.
  •  Author qualification of CSV documents through system life cycle as outlined in applicable SOPs. This includes deliverables such as user requirements, functional/design specifications, qualification protocols, testing summary reporting, and support documentation (i.e. traceability matrices, deviations, SOP, etc.). Manage documentation from creation to approval.
  • Review laboratory requirements and define procedures for instrument and data management/data integrity for new instrumentation.
  • Implement 21 CFR Part 11 for new and existing testing computerized laboratory instruments, perform gap assessments and define resolutions in compliance with cGMP requirements.
  • Support installation and requalification activities when needed to ensure proper systems startup, troubleshooting during use and recommend changes to improve system design.
  • Work collaboratively across functions including Quality, IS, vendors and scientific lab staff.
 
Employee Value Proposition:
Receive a lot of variety of analytical experience - growing group and department with different systems and templates to learn.
Red Flags: no experience with analytical instruments, not familiar with drafting documentations, not familiar with collaborating on creating software permissions and settings.
 
 
Interview Process: Skype/Webex (online)/Phone interviews
 
 
 
We invite qualified candidates to send your resume to resumes@3keyconsulting.com. If you decide that you’re not interested in pursuing this position, please feel free to look at other positions on our website www.3keyconsulting.com. You are welcome to also share this posting with anyone you think might be interested in applying for this role.
 
 
 
 
 
Regards,
 
3KC Talent Acquisition Team
 
 

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