Validation Engineer - (JP9556)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 2, 2026
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Job Description:
Job Title: Validation Engineer - (JP9556) Location: Thousand
Oaks, CA. Employment Type: Contract Business Unit: Pivotal AS
Duration: 1 years (with likely extensions and/or conversion to
permanent) Posting Date: 12/09/2021 Notes: 3 Key Consulting is
hiring an Associate Scientist for a consulting engagement with our
direct client, a leading global biopharmaceutical company. Job
Description: 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. Reports to a manager. Why is the
Position Open? Planned Project. Top Must Have Skills: 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: Unclear communication, negative attitude, no
experience with qualifications or validations, no experience with
any analytical equipment, not familiar with drafting documents, not
familiar with software permissions/configurations 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. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Burbank , Validation Engineer - (JP9556), Healthcare , Thousand Oaks, California
