Computer System Validation (CSV) Engineer

Carlton National Resources Inc

wakefield, MA

JOB DETAILS
SKILLS
Biology, Code of Federal Regulations, Computer Science, Computer Skills, Computer Systems, Maintain Compliance, Procedure Implementation, Regulations, Risk Analysis, Software Development Lifecycle (SDLC), Standard Operating Procedures (SOP), System Lifecycle, System Validation, Traceability, Validation Plan
LOCATION
wakefield, MA
POSTED
30+ days ago

Position Overview:

The Computer System Validation (CSV) Engineer is responsible for the validation of computerized systems and infrastructure within regulated environments. This role involves developing and executing validation protocols to ensure compliance with 21 CFR Part-11, Annex-11, and other regulatory standards.

Key Responsibilities:

  • Develop, approve, and execute validation deliverables for computerized systems, including validation plans, risk assessments, and traceability matrices.
  • Manage and update validation activities, ensuring alignment with day-to-day operations and project work.
  • Review and provide feedback on System Delivery Life Cycle (SDLC) documents, ensuring adherence to Standard Operating Procedures (SOPs).
  • Author and update SOPs, templates, and related documentation to support ongoing CSV compliance.

Required Qualifications:

  • Bachelor's degree in Computer Science, Life Sciences, or related field.
  • 5+ years of experience in computer system validation within life sciences.
  • Knowledge of CSV regulatory standards (21 CFR Part-11, Annex-11, GAMP5).

About the Company

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Carlton National Resources Inc

Located in Boston’s Seaport district, Carlton National Resources INC. is a National consulting firm focused on temporary, individual contract placement of Senior Level Hardware and Software Engineers. As well as servicing the Medical Regulatory/Quality/Validation (Process and Product)/(IQ/OQ/PQ) markets, helping our clients achieve compliance with FDA guidelines and regulations. We are also a Cleared facility with a Government cage code and have the ability to hold and process Government Secret Clearances for our consultants.

Our senior management team has over 30+ years of experience providing highly customized and niche-focused consulting solutions

We work across a broad range of industries. Our technical core competencies include Software Embedded Engineering, Software Applications/UI development, Firmware/DSP, Hardware, FPGA/ASIC Design and Verification, Board Design, RF, Medical Quality/Validation (Process and Product)/(IQ/OQ/PQ).

Carlton Approach:

Our business philosophy of keeping internal overhead as low as possible, enables Carlton to operate at smaller margins than our competitors. This allows us to provide our clients with fair bill rates, while at the same time paying the contractor above market pay rates. This leads to our ability to deliver our consultants at a higher percentage than our competition, longer assignments and most importantly more completed projects for our clients. Whether your needs are for long term project or a short term solution, our experienced team can quickly and effectively provide the support you need.

INDUSTRY
Management Consulting Services
WEBSITE
http://www.carltonnational.com/