CSV / Computer Systems Validation Engineer

CSV / Software Quality Engineer ufeff Job Description Join a leading medical device manufacturer as a Software Quality Engineer, where you will play a critical role in implementing three new software and hardware technologies aimed at enhancing defect detection during the manufacturing process. This position is dedicated to projects that bring new manufacturing technologies through the quality and validation process, supporting Real Time Release (RTR) within the manufacturing quality system. Responsibilities + Serve as the dedicated Software Quality Engineer supporting new manufacturing technologies. + Create and execute validation strategies in partnership with the validation engineering team. + Ensure full software lifecycle compliance for manufacturing applications. + Apply risk-based thinking to software and system validation activities. + Review and approve development of lifecycle and validation documentation, including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Validation documentation, Failure Modes and Effects Analysis (FMEA), Traceability Matrices, Development Reports, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). + Ensure traceability across requirements, risks, testing, and validation evidence. + Support CSV activities for 5u20136 new IT/OT applications, ensuring alignment with internal medical device quality system requirements. + Support validation execution, deviation handling, and validation closure. + Collaborate with engineering and automation teams on software-enabled equipment validation. + Support systems interfacing with PLCs and manufacturing hardware. + Support change control activities, reviewing and assessing software and system changes for validation and quality impact. + Ensure appropriate documentation, testing, and approvals are completed prior to release. Essential Skills + Bacheloru2019s degree in Engineering, Computer Science, or related technical discipline. + Minimum 4 years of experience in Quality, specifically in validation or Computer System Validation (CSV). + Experience within medical device quality systems. + Strong understanding of the Software Development Lifecycle (SDLC), CSV, and validation documentation and execution. + Experience supporting software used in manufacturing or production environments. + Ability to work independently on long-term, dedicated projects. Additional Skills & Qualifications + Experience with IT/OT systems in manufacturing environments. + Familiarity with PLC integrated systems. + Experience with Software Validation / Quality on PC-based applications and C++ software. + Prior experience supporting Real Time Release (RTR) initiatives. + Experience in equipment validation. Work Environment This is a hybrid role, requiring three days on-site and two days off-site. The work environment includes collaboration with engineering and automation teams, and involvement in validation activities for manufacturing software and equipment. Job Type & Location This is a Contract position based out of Jacksonville, FL. Pay and Benefits The pay range for this position is $60.00 - $60.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in Jacksonville,FL. Application Deadline This position is anticipated to close on Mar 13, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email ( ) for other accommodation options.

Created: 2026-03-02