Validation Engineer II​/III; CSV

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.

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).

• Develop moderately complex test protocols, provide 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.
• Investigate / troubleshoot 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.
• Provide 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.
• Perform periodic reviews and ongoing support of validated systems post Go‑Live.
• Perform revalidation and change control validation related activities.
• Apply complex system validation principles to work assignments.
• Execute and review control systems validation activities including projects associated with BMS, CMS, and other automation upgrades.
• Assess the impact of system changes through 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.

• Fully onsite position
• Adaptability required as work schedule may change based on business needs
• Criminal background check required
• Other duties as assigned

A minimum of a Bachelor’s degree in Engineering.

5+ years of validation experience.

• Strong written and oral communication skills: ability to communicate with employees of all experience levels.
• Ability to report on project activity in a clear and concise manner.
• Ability to negotiate when necessary and compromise with other project team representatives to achieve project goals.
• Ability to listen and respect fellow project team member’s ideas and opinions and work through conflict and disagreements.
• GMP compliance knowledge including 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, including 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.

The annual salary range for this position based upon level hired is: $90,000–$130,000.

• Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
• Occasionally required to…