Validation (CQV) Engineer

Job Description

Job Description

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.

Areas of Expertise

• 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

Requirements

Education Requirements

• Bachelor’s degree in Engineering or Science (minimum).
• 7+ years of validation experience in the life sciences industry.

Benefits

• Administrative shift
• 1-year contract with possible extension