Validation Engineer II/III (CSV)

Genezen•Lexington, MA

2d•$85,000 - $130,000•Onsite

About The Position

The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team. JOB SUMMARY The incumbent is responsible for assisting in completion of all computer system validation project milestones. This includes writing all validation deliverables within the Computer System Lifecycle, e.g. Validation Plans, Summary Reports, Configuration Specifications. Responsible for developing, revising test validation procedures/protocols, and preparation of all relevant documentation in accordance with appropriate regulatory agency validation requirements, quality management system and current industry practices (includes standard operating procedures, technical reports and risk assessments).

Requirements

A minimum of a Bachelors degree in Engineering
5+ years of validation experience
The individual must possess strong written and oral communication skills: The ability to communicate with employees of all experience levels.
The ability to report on project activity in a clear and concise manner.
The ability to negotiate when necessary and compromise with other project team representatives to achieve project goals.
The ability to listen and respect fellow project team member’s ideas and opinions and work through conflict and disagreements.
GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity Guidance, ICH Q7A requirements, and GAMP 5.
Experience in thorough testing of applications, computerized systems, changes and implementations
Excellent written and oral communication to include accurate and legible documentation skills.
Ability to work independently in a fast-paced environment with a strong work ethic.
Must be able to sit or stand for prolonged periods of time.
Good knowledge and skills in engineering of Automation for HVAC/ Process Utility/Monitoring Building Management Systems.

Responsibilities

Develop moderately complex test protocols, provides on-site execution support, data analysis, and report generation for various installation, operational and performance qualification activities.
Ensure performance of all qualification activities is in accordance with internal procedures, cGMP industry and regulatory guidance.
Investigates / troubleshoots validation problems.
Support and/or initiate investigations into protocol non-conformances and site deviations.
Serve as initiator and owner of validation related change controls and corrective and preventative actions.
Provides input to standard operating procedures related to validation practices.
Support the implementation of validation programs (e.g., requalification).
Represent the validation department at team meetings or projects.
Performs periodic reviews and ongoing support of validated systems post Go-Live.
Perform revalidation and change control validation related activities.
Ability to apply complex system validation principles to work assignments.
Responsible for executing and reviewing control systems validation activities including projects associated with BMS, CMS, and other automation upgrades.
Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
Assist validation activities of cross functional teams that include technical functions such as Quality Control, Information Systems, Manufacturing and QA Engineering.
Other duties as assigned