Project Engineer – VHP Decontamination & Isolator Systems

Verista; Indianapolis (IN); On-site; USD 85,000 - 127,000; Full time

Benefits offered by this job

Competitive pay

Life Insurance

Health Savings Account

Paid Time Off

Tuition Reimbursement

Parental Leave

Job summary

Verista, located in Indianapolis, IN, seeks a qualified professional to lead VHP cycle development for pharmaceutical isolators and ensure adherence to regulatory GMP standards. You will design validation strategies, author PQ protocols, and collaborate with Validation, Engineering, Manufacturing, and Quality teams to drive compliant lifecycle management.

Required are hands-on VHP experience, aseptic processing knowledge, BI placement skills, and strong technical writing abilities.

Qualifications

• 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.

Responsibilities

• Develop and optimize VHP decontamination cycles for pharmaceutical isolators and troubleshoot cycle performance issues.
• Author, review, and revise validation documentation including PQ protocols, reports, risk assessments, and SOPs.
• Collaborate with Validation, Engineering, Manufacturing, Quality, and other cross‑functional stakeholders to ensure cGMP compliance.
• Analyze cycle and validation data, perform technical assessments, and prepare final reports.

Job description

Verista, located in Indianapolis, IN, seeks a qualified professional to lead VHP cycle development for pharmaceutical isolators and ensure adherence to regulatory GMP standards. You will design validation strategies, author PQ protocols, and collaborate with Validation, Engineering, Manufacturing, and Quality teams to drive compliant lifecycle management.

Required are hands-on VHP experience, aseptic processing knowledge, BI placement skills, and strong technical writing abilities.