Validation (CQV) Engineer

BioPharma Consulting JAD Group•College Station, TX

1d•Onsite

About The Position

The Validation Engineer is responsible for providing scientific and technical support for product launches, technology transfers, and new technology introductions at the FDBT site. This role executes key validation lifecycle activities—including Cycle Development (CD), Commissioning & Qualification (CQ), Performance Qualification (PQ), and Periodic Reviews (PR)—while collaborating closely with cross‑functional teams across the site and occasionally with network partners. Emphasis is placed on right‑first‑time execution, compliance, and continuous improvement.

Requirements

On‑site role; remote work is not permitted.
Experience creating full validation lifecycle documentation: URS, FRS, DS, engineering specifications
Validation protocols (VPP, IQ, OQ, PQ)
System Impact Assessments, Requirements Traceability Matrix, Final Reports
Strong understanding of validation processes and regulatory requirements.
Ability to independently troubleshoot, resolve, and communicate technical issues.
Proven experience leading cross‑functional teams and coordinating complex projects.
Ability to develop and manage detailed project plans and timelines for IQ/OQ/PQ/RQP execution.
Working knowledge of Computerized Systems Validation (CSV).
Excellent technical writing skills for SOP creation and updates.
Proficiency in Microsoft Word, Excel, and PowerPoint.
Ability to work independently, multitask, and support multiple projects simultaneously.
Bachelor’s degree in Engineering or Science (minimum).
7+ years of validation experience in the life sciences industry.

Nice To Haves

Kneat electronic validation documentation
Data loggers (pre/post calibration procedures)
Temperature mapping: cold rooms, freezers, refrigerators, incubators
Laboratory equipment (e.g., Mass Photometer)
Autoclaves & cycle development EMPQs
Biowelders
Culture chemistry analyzers
Smoke studies
Fillers
VHP decontamination & cycle development
Bioquell Qube
Mixers, tanks, VCells
AKTA systems
Filter integrity testers
Pumps
Centrifuges
Downflow hoods
Weight scales
SME Water Systems (WFI, RODI)
Clean gas utilities
Facilities systems

Responsibilities

Execute key validation lifecycle activities—including Cycle Development (CD), Commissioning & Qualification (CQ), Performance Qualification (PQ), and Periodic Reviews (PR)
Collaborate closely with cross‑functional teams across the site and occasionally with network partners
Support implementation of new process technologies aligned with business and regulatory needs
Ownership of vendor‑performed validation activities, including: Review and approval of vendor protocols, Issue resolution, Validation deviation reporting, Summary report generation
Coordinate and execute tactical validation activities: Sample collection, Data retrieval, Documentation completion per protocol requirements
Provide guidance and support to junior team members