About The Role

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.

Key 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).
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
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.
Provide guidance and support to junior team members.
Must be available to work as needed, including holidays and weekends.