Validation Engineer (Computer Systems)

Salary: $65,000 to $80,000. Final pay determinations will depend on various factors, including experience level, education, knowledge, skills, and abilities.

Responsibilities

• Schedules and executes computer system qualifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Assembles and composes the final report and circulates for approval.
• Executes validation studies (utility, equipment, cleaning, process, computer, and new products) to include protocol preparation, scheduling, protocol execution, and final report preparation. Presents results to Regulatory Agency when necessary.
• Participates in dry running the manufacturing system applications and develops the test scenarios, test environments, test scripts.
• Develops and updates full life cycle documents including URS, FDS, DS, risk assessments, impact assessment, FMEAs and test and qualification protocols.
• Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
• Represents Technical Services in teams assembled to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Authors validation master plans and validation project plans outlining qualification requirements.
• Authors the documentation needed for MES(EBR), Historian(QMIB), manufacturing applications and infrastructure like industrial data center, etc.
• Provides technical support for Investigations, Action Plans, Change Controls and Risk Assessments as required.
• Generates innovative solutions to solve difficult problems that may impact multiple disciplines.
• Additional projects and tasks as assigned.
• All employees are responsible for ensuring compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per roles and responsibilities.

Requirements

• Bachelor’s Degree in a Science or Engineering field of study.
• Minimum of one year of related experience in a cGMP facility, including experience with FDA regulations, medical, drug and device products.
• Installation, Operational and Performance Qualification protocol generation and execution experience.
• Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.
• Excellent technical writing and verbal communication skills. Experienced in negotiating.
• Understanding of MES(EBR), historian, OEE, and other manufacturing applications.
• PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency.
• Good communication and leadership skills.
• Good judgment and decision-making skills.
• Problem-solving and multi-tasking abilities.
• Project supervision and project management skills.
• Ability to work independently.
• Ability to adapt and handle change.
• Knowledge of cGMP Process and Product Validation requirements and techniques.
• Must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

Benefits

• 401(k) plan with company contributions.
• Paid vacation, holiday, and personal days.
• Employee assistance program.
• Health benefits including medical, prescription drug, dental, and vision coverage.
• Life insurance and disability coverage.
• Wellness program.