CSV Engineer

San Francisco, CA, US • Posted 3 days ago • Updated 4 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Collaboration
  • Quality Assurance
  • Testing
  • Training
  • Regulatory Compliance
  • Auditing
  • GxP
  • Element Management System
  • EMS
  • GMP
  • Manufacturing
  • Software Development
  • Software Development Methodology
  • Functional Requirements
  • FRS
  • Risk Assessment
  • Regulatory Affairs
  • Data Integrity
  • IQ
  • OQ
  • PQ
  • Reporting
  • Computer Science
  • GAMP
  • Enterprise Resource Planning
  • LIMS
  • MES
  • Documentation
  • Technical Writing
  • Analytical Skill
  • Problem Solving
  • Conflict Resolution
  • Communication
  • Cloud Computing
  • Verification And Validation
  • Computerized System Validation
  • Biotechnology
  • Research

Summary

Roles & Responsibilities:
  • Develop and implement validation strategies for computer systems and software applications.
  • Create and maintain validation documentation, including Validation Plans, Protocols (IQ/OQ/PQ), and Validation Reports.
  • Perform risk assessments to identify potential issues and ensure compliance with regulatory requirements.
  • Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure successful validation of systems.
  • Conduct validation testing and review test results to ensure systems meet specified requirements.
  • Provide training and support to staff on validation processes and procedures.
  • Stay up-to-date with industry trends and regulatory changes to ensure ongoing compliance.
  • Participate in audits and inspections by regulatory agencies.
  • Execute Validation Project Plans (VPPs) for manufacturing GxP systems such as, Client, EMS, & PCS.
  • Support the execution of VPPs to qualify systems for GMP Manufacturing Equipment in accordance with Software Development Lifecycle (SDLC) procedures as per GAMP5 industry standards
  • ssist site Automation groups in configuring I/O and executing CSV protocol requirements.
  • Independently perform CSV lifecycle deliverables, including but not limited to, Functional Requirements Specification (FRS), Configuration Specification (CS), Electronic Records and Electronic Signatures (ERES), Risk Assessment (RA), Data Integrity (DI) Assessment, IQ/OQ/PQ, & Summary Report

Requirements:
  • Bachelor's degree in Computer Science, Engineering, or a related field.
  • Minimum of 2-5 years of experience in computer system validation or a related field.
  • Strong knowledge of regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP 5).
  • Experience with validation of various types of systems, including ERP, LIMS, and MES.
  • Excellent documentation and technical writing skills.
  • Strong analytical and problem-solving abilities.
  • bility to work independently and as part of a team.
  • Excellent communication and interpersonal skills.
  • Preferred: Certification in Computer System Validation or related areas.
  • Experience with cloud-based systems and software validation, experience with Blue Mountain RAM.
  • 3+ years of work experience with Computer System Validation.
  • 3+ years of Biotechnology Research experience.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: e36ade6b0f84695a3536398146f4dc93
  • Posted 3 days ago
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