Senior Validation Engineer, Biotech – Hybrid (JP11465)
Company: 3 Key Consulting
Location: Thousand Oaks
Posted on: April 1, 2026
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Job Description:
Job Title: Senior Validation Engineer, Biotech – Hybrid
(JP11465) Location: Thousand Oaks, CA (Hybrid, twice a week on
site) Employment Type: Contract to Hire Business Unit: Business and
Operations Management Duration: Initial 3 months with likely
extension(s). Posting Date: 05/22/2023. Rate : $50-58 / Hour plus
benefits. Note: Onsite 2-3 times a week 3 Key Consulting is hiring
a Senior Validation Engineer 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;
possess the ability to effectively communicate and multitask. Works
under immediate supervision with the ability to work independently
and as a team. Top 3 Must Have Skill Sets: Experience with
qualifying analytical laboratory computer instrumentation systems.
Validation actions including but not limited to leading, developing
and implementing strategies and authoring required COTS Validation
documents. (LCMS, FTIRs, Titrators etc.) Knowledge of cGMPs, ALOCA,
Data Integrity requirements (21 CFR Part 210/211, Part 11) and
Analytical Instrument Qualifications (USP 1058). Team player and
independent working with excellent communication Responsibilities :
Implement and coordinate the installation and qualification of
laboratory equipment and computer systems (hardware, software, and
accessory systems etc.) 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
(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 equipment, testing computerized
laboratory instruments, perform gap assessments and define
resolutions in compliance with company standards and cGMP
requirements. Support installation and re-qualification activities
when needed to ensure proper systems startup, troubleshooting
during use and recommend changes to improve application software’s
system design. Work collaboratively across functions including
Quality, IS, vendors and scientific lab staff. Red Flags: Unclear
communication. Unfamiliar with analytical instruments. Unfamiliar
with data integrity/21CFR Part 11 requirements. Interview process:
1 WebEx Interview We invite qualified candidates to send your
resume to recruiting@3keyconsulting.com . If you decide that you’re
not interested in pursuing this position, please feel free to take
a look at the other positions on our website
www.3keyconsulting.com/careers. You are welcome to also share this
opportunity with anyone you think might be interested in applying
for this role. Regards, 3KC Talent Acquisition Team
Keywords: 3 Key Consulting, Rancho Cucamonga , Senior Validation Engineer, Biotech – Hybrid (JP11465), Engineering , Thousand Oaks, California
