A leading provider of solutions for the life sciences industry is seeking a skilled Senior Validation Engineer with expertise in Computerized System Validation (CSV) and particle counter implementation. This is a hands-on role supporting regulated environments, ensuring compliance, and facilitating the deployment and qualification of advanced systems used in pharmaceutical and laboratory operations.
Key Responsibilities:
Lead the implementation and validation of particle counting systems within a GMP-regulated environment.
Execute CSV protocols and system testing procedures; document results and deviations clearly and accurately.
Collaborate with IT and technical teams for issue resolution and system troubleshooting.
Participate in requirements gathering and root cause analysis to support system configuration and integration.
Ensure all activities align with project schedules and compliance standards.
Draft and execute key validation documents including validation plans, user requirements, IQ/OQ/PQ protocols, RTMs, VSRs, and change control documentation.
Conduct risk assessments and impact analyses related to equipment, software systems, and process functions.
Support capital equipment implementation and system integration, including data flow and testing of automated systems.
Design and run engineering studies to define and verify critical process parameters prior to system validation.
Qualifications:
Bachelor's degree or equivalent experience in a related field.
Minimum of 4 years experience in validation, with a focus on CSV and lab/manufacturing automation.
Familiarity with 21 CFR Part 11 and working within cGxP pharmaceutical environments.
Proficiency with Microsoft Office and general PC tools.
Experience communicating technical requirements both in writing and verbally across different levels of an organization.
Strong analytical thinking, attention to detail, and ability to work both independently and as part of a cross-functional team.
Prior experience with complex system validation projects and automated lab or manufacturing equipment.
Additional Details:
This is a full-time, on-site position in Summit, NJ.
Salary is commensurate with experience and influenced by factors such as location, background, and industry demand.
A full benefits package is available, including health, dental, vision, 401(k) with matching, PTO, paid parental leave, and more.