6485 - Project Engineer / Project Engineer 2

Project Engineer Responsibilities:

• Develop and optimize VHP (Vaporized Hydrogen Peroxide) decontamination cycles for pharmaceutical manufacturing isolators.
• Develop Biological Indicator (BI) placement strategies, including identification of worst-case locations and execution of challenge studies.
• Execute VHP development cycles and troubleshoot cycle performance, distribution, and decontamination issues.
• Author and execute Performance Qualification (PQ) protocols for isolator decontamination systems.
• Analyze cycle and validation data, perform technical assessments, and prepare final reports.
• Author, review, and revise validation documentation, including:
  • Qualification protocols and reports
  • Risk assessments
  • SOPs
  • VHP cycle development documentation
  • Supporting validation and lifecycle documentation
• Provide technical guidance on VHP implementation, validation strategy, and lifecycle management.
• Ensure activities and documentation comply with cGMP requirements and applicable regulatory/industry standards.
• Collaborate with Validation, Engineering, Manufacturing, Quality, and other cross-functional stakeholders.

Requirements:

• Demonstrated hands-on experience with VHP cycle development and qualification for pharmaceutical isolators.
• Strong knowledge of aseptic processing and contamination control principles.
• Experience developing and executing BI placement and worst-case challenge strategies.
• Experience authoring and executing PQ protocols and preparing final validation reports.
• Strong understanding of GMP validation requirements within pharmaceutical or biotechnology manufacturing.
• Experience troubleshooting VHP cycle development and performance issues.
• Strong technical writing skills with experience authoring protocols, reports, risk assessments, and SOPs.
• Knowledge of current regulatory expectations and industry best practices for VHP decontamination and isolator qualification.
• Strong analytical, problem-solving, and cross-functional communication skills.
• Experience supporting sterile/aseptic pharmaceutical manufacturing operations.
• Experience with VHP systems used in filling, packaging, or other aseptic manufacturing isolators.
• Familiarity with contamination control strategies and the qualification/lifecycle management of barrier systems.