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Validation Engineer  (JP9623)

Thousand Oaks, ca · Biotech/Pharmaceutical
Job Title:   Validation Engineer  (JP9623)
Location:  Thousand Oaks, CA    
Employment Type: Contract
Duration: 12 months with likely extensions
Job posting date: 1/13/2022
Note:  Onsite Essential

3 Key Consulting is hiring a Validation Engineer for a consulting engagement with our direct client, a leading global bio-pharmaceutical company.

Job Summary:
  • 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.
  • Has knowledge of commonly used concepts, practices, and procedures within a particular field.
  • Relies on instructions and pre-established guidelines to perform the functions of the job.
  • Works under immediate supervision with the ability to work independently and as a team. Reports to a manager.

Top Must have Skill Sets:
  • Experience with qualifying analytical laboratory computer instrumentation systems. Validations including leading, developing and implementing validation strategies and authoring required validation documents. (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).
  • Team player and independent working. Excellent communication.

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:
The person in this role will increase their experience with different type of analytical instruments and COTS validation

Red Flags:
  • No experience with computerized analytical equipment.
  • No experience with software permissions/configurations.
  • No experience with drafting or reviewing documents.
  • Unclear communication and not a team player.
  • Unfamiliar with 21CFRPart11.

Interview Process:
Video conference. 

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.

3KC Talent Acquisition Team
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