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Validation Engineer Senior (JP8405)

Thousand Oaks, CA · Biotech/Pharmaceutical
Job Title:  Validation Engineer Senior (JP8405)
Location: Thousand Oaks, CA. (Combination onsite/offsite)
Employment Type:  Contract
Business Unit: N/A
Duration: 7+ months (with likely extensions)
Posting Date: 3/29/21
3 Key Consulting is hiring a Validation Engineer Senior for a consulting engagement with our direct client, a leading global biopharmaceutical company.
Job Description:
*** This role will be remote and onsite***
***Biotech/pharma experience preferred****
  • Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems.
  • Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Implement 21 CFR Part 11 for new and existing computerized analytical instruments, perform gap assessments and define resolutions in compliance with cGMP requirements.
  • Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.
Why is the Position Open?
Supplement additional workload on team.
Top Must-Have Skill Sets:
  • Experience drafting quality documentation and validating analytical laboratory instrumentation (eg HPLC, Spectrophotometer, Karl Fisher Titrator, ECHO etc.)
  • Knowledge of cGMPs and data integrity requirements (21 CFR Part 210/211, Part 11) and analytical instrument qualification (USP 1058).
  • Perform gap assessments on software permissions/configurations for analytical instruments.
  • 4.Communication and multitasking skills
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.
Basic Qualifications:
  • Highschool diploma and 10 years.
Preferred Qualifications:
  • Biotech/pharma experience.
Employee Value Proposition:
The person in this role will increase their experience with different type of analytical instruments and COTS validation
Red Flags:
  • No analytical instrument experience.
  • No experience with analytical instrument software gap assessments.
  • No experience with analytical instrument software permissions/configurations and writing test protocols.
Interview process:
Video Skype Panel Interview
We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
3KC Talent Acquisition Team
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