Senior Validation Engineer – Integrated Environmental Monitoring System

Project Duration: 3 months - 40 hours a week
Employment Type: Fully On-Site Project/Contract Assignment
Seniority Level: Senior
Industry: Pharmaceutical/Biotechnology
Functional Area: CQV and CSV

Position Summary

VTI is seeking one Senior Validation Engineer to support the qualification and validation of an Integrated Environmental Monitoring System within a regulated pharmaceutical manufacturing environment. The engineer will develop, execute, and close lifecycle and qualification documentation in accordance with internal procedures, applicable SOPs, project requirements, and GMP expectations.

The successful candidate will serve as a document coordinator/owner and change owner throughout the qualification phase. The assignment includes IQ, OQ, and PQ activities; cycle-development support; discrepancy resolution; requirements traceability; and preparation of final validation reports.

Key Responsibilities

• Develop validation protocols and serve as document owner throughout their review and approval lifecycle.

• Prepare and manage validation lifecycle documentation, including:

  • System and risk assessments
  • User Requirements Specifications (URS)
  • Design Qualification (DQ)
  • Change-management documentation
  • Validation and equipment specifications
  • Requirements Traceability Matrices (RTMs)
  • Test Summary Reports
  • Final Validation Reports

• Develop, execute, document, and close Installation Qualification (IQ) protocols to verify that the Environmental Monitoring System is installed according to approved design specifications.

• Develop, execute, document, and close Operational Qualification (OQ) protocols to demonstrate that the system operates according to specifications and its intended use.

• Develop, execute, document, and close Performance Qualification (PQ) protocols to demonstrate consistent system performance under intended operating conditions.

• Support the execution of cycle-development protocols.

• Serve as change owner during the project’s qualification phase in accordance with internal change-management procedures.

• Initiate, investigate, document, and close protocol discrepancies in accordance with established procedures.

• Serve as coordinator/owner for requirements traceability documentation and qualification summary reports.

• Collaborate with the Engineering Services Team and other project stakeholders to maintain schedule alignment and resolve qualification issues.

• Maintain current training on all applicable Standard Operating Procedures and project-specific requirements.

• Perform additional validation activities assigned by the Engineering Services Team as needed.

Project Deliverables

The Senior Validation Engineer will be accountable for completing the following deliverables according to the approved project schedule:

• Generate, route, and obtain approval for all required protocols and lifecycle documentation.
• Complete IQ and OQ protocol execution and closure.
• Complete PQ protocol execution and closure.
• Document and resolve protocol discrepancies.
• Complete the Requirements Traceability Matrix.
• Generate and route the Test Summary Report and Final Validation Report for approval.
• Deliver complete, accurate, and inspection-ready validation packages.

System Overview

The role will support validation of the Environmental Monitoring Solution, which may include the following components:

Integrated Environmental Monitoring System (IEMS)

An open-architecture platform that centralizes environmental monitoring and data management for regulated facilities. Monitored parameters may include:

• Airborne particle counts
• Microbial contamination
• Differential pressure
• Temperature
• Relative humidity
• Other GMP-critical environmental conditions

Particle Monitoring

The solution may incorporate:

• CI-x70 and x50-series portable particle counters
• CI-3100-series remote particle sensors
• Continuous monitoring systems for cleanrooms and aseptic processing areas
• Monitoring of critical airborne-particle size ranges, including ≥0.5 µm and ≥5.0 µm

Microbial Monitoring

The solution may include high-efficiency biological air samplers featuring:

• Viable airborne-microorganism sampling
• Inertial impaction onto standard 90 mm agar plates
• Design and validation aligned with ISO 14698 guidance
• Autoclavable AISI 316L stainless-steel construction

Required Qualifications

• Bachelor’s degree in engineering, life sciences, or a related technical discipline.
• 8+ years of experience in pharmaceutical, biotechnology, or other regulated life-sciences environments.
• Demonstrated experience developing and executing IQ, OQ, and PQ protocols.
• Experience authoring validation lifecycle documentation, including URS, DQ, risk assessments, traceability matrices, summary reports, and final validation reports.
• Working knowledge of GMP, data-integrity principles, and controlled-documentation practices.
• Experience managing changes, deviations, or protocol discrepancies through closure.
• Ability to independently coordinate document review and approval workflows.
• Strong technical writing, organization, investigation, and cross-functional communication skills.
• Ability to work effectively under a compressed three-month project schedule.

Preferred Qualifications

• Experience validating environmental monitoring systems in cleanroom or aseptic-processing environments.
• Experience with EMS, particle counters, remote particle sensors, or HEBAS microbial air samplers.
• Familiarity with ISO 14698 and environmental-monitoring requirements.
• Knowledge of computerized-system validation, electronic records, audit trails, and regulated data management.