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
Assist 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.
Ability 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.
Numbers & Facts
Location
San Francisco, CA
Skills
Analysis Skillsunmatched
Automationunmatched
Biotech and Pharmaceuticalunmatched
Cloud Computingunmatched
Communication Skillsunmatched
Computer Certificationsunmatched
Computer Scienceunmatched
Computer Skillsunmatched
Computer Softwareunmatched
Computer Systemsunmatched
Cross-Functionalunmatched
Data Qualityunmatched
ERP (Enterprise Resource Planning)unmatched
FDA (Food and Drug Administration)unmatched
GMP (Good Manufacturing Practices)unmatched
GxPunmatched
Identify Issuesunmatched
Industry Standardsunmatched
Industry/Trade Analysisunmatched
Input/Outputunmatched
Interpersonal Skillsunmatched
Laboratory Information Management System (LIMS)unmatched
Maintain Complianceunmatched
Manufacturing Equipmentunmatched
Manufacturing Systemsunmatched
Problem Solving Skillsunmatched
Process Validationunmatched
Project Planningunmatched
Quality Assuranceunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Regulatory Requirementsunmatched
Risk Analysisunmatched
Software Development Lifecycle (SDLC)unmatched
Software Validationunmatched
System Validationunmatched
Team Playerunmatched
Technical Writingunmatched
Testingunmatched
Training/Teachingunmatched
Validation Documentationunmatched
Validation Planunmatched
Validation Testingunmatched
Writing Skillsunmatched
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