6485 - Project Engineer / Project Engineer 2

Verista•Indianapolis, IN

4d•Remote

About The Position

Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities. Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day. Company Culture Guidelines & Values: We empower and support our colleagues We commit to client success at every turn We have the courage to do the right thing We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged. We constantly acquire new skills and learn from our experiences to enhance our collective expertise

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.

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.