Project Engineer – VHP Decontamination

About the Role

We are seeking a Project Engineer with hands-on experience in VHP decontamination cycle development and qualification for pharmaceutical manufacturing isolators. This role will support VHP cycle development, BI challenge studies, PQ execution, troubleshooting, and validation documentation within a GMP-regulated sterile manufacturing environment.

Responsibilities

• Develop, optimize, and troubleshoot VHP decontamination cycles for pharmaceutical isolators.
• Develop BI placement strategies, identify worst-case locations, and execute challenge studies.
• Author and execute PQ protocols and prepare validation reports.
• Analyze cycle and validation data and perform technical assessments.
• Prepare and review validation protocols, reports, risk assessments, SOPs, and VHP documentation.
• Support contamination control, VHP implementation, and lifecycle management.
• Ensure activities comply with cGMP and applicable regulatory requirements.
• Collaborate with Engineering, Validation, Manufacturing, Quality, and other cross-functional teams.

Requirements

• Hands-on experience with VHP cycle development and qualification for pharmaceutical isolators.
• Strong knowledge of aseptic processing, contamination control, and sterile manufacturing.
• Experience with BI placement/worst-case studies and PQ execution.
• Strong GMP validation and technical writing experience.
• Experience troubleshooting VHP cycle performance and decontamination issues.
• Experience with VHP systems used in filling, packaging, or aseptic isolators.
• Strong analytical, problem-solving, and communication skills.

Skills

• VHP
• Isolator Qualification
• BI Studies
• PQ
• GMP Validation
• Aseptic Processing
• Contamination Control