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Computer Systems Validation Specialist (CSV Specialist)

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Computer Systems Validation Specialist (CSV Specialist)

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    Green Cross Biotherapeutics Inc.

    Computer Systems Validation Specialist (CSV Specialist)

    Green Cross Biotherapeutics Inc. Saint-Laurent, Quebec

    Engineering and science
    Posted 25 day(s) ago | Still Open
    Permanent 37.5 h - Full time As soon as possible

    Description

    Position Summary

    The Computer Systems Validation Specialist (CSV Specialist) is responsible for the completion of all phases of assigned automation and computer system validation activities ensuring full compliance to regulatory standards and Green Cross Biotherapeutics (GCBT) requirements.

    Key Duties and Responsibilities

    • Actively completing, coordinating and managing all phases of assigned automation and computer system validation projects and related activities including but not limited to:
    o Development of project plans to support computerized system validation planning
    o Development, review and/or QV approval of specification and verification documents including user requirements specification, functional specification, design specification, configuration testing, function testing, requirements testing, integration testing and module (unit) testing
    • Development, support and facilitation of change management process for computer and automation systems. Analyze and perform assessments for software change controls for computer system validation, data integrity, hardware interactions and security impact.
    • Provide coaching and mentoring to the organization and validation staff regarding CSV, SDLC, data integrity, security standards, regulations, guidance and best practices.
    • Develop and maintain risk management documentation including software risk assessments.
    • Evaluate and define computer system validation approach for applicate software or GxP computerized systems.
    • Writes validation project plans, protocols, reports and compiles final validation report summaries as required to meet qualification and validation objectives.
    • Authors, reviews and executions qualification and validation documents within defined quality system standards and procedures for automation platforms, equipment PLC and control systems, and computerized systems based on approved design specification. Evaluates and analyzes qualification/validation data collected while verifying acceptability of the data and compliance with the protocol.
    • Conducts validation discrepancy investigations; identifies and implements effective root cause analyses and corrective actions.
    • Reviews engineering drawings, design documents and specifications for compliance to GMP/validation principles and provides feedback to project team for noted deficiencies or improvements.
    • Interacts regularly with project team members and influences overall scope development and communicates with all levels of employees within and outside the team.
    • Reviews qualification/validation packages for completeness and accuracy, compliance with policies, procedures and accurate data analysis related to computer system
    • Perform additional duties as assigned

    Qualifications

    • Education: At minimum, must have a University degree (BSc) in Chemistry, Biochemistry or Microbiology or Bachelor’s degree in Engineering
    • At least 6 years’ experience in computer system validation. Experienced in executing test cases, test scripts and documenting test results for computerized systems and automation platforms.
    • Ability to effectively lead validation projects, coordinate junior level personnel and delivery results.
    • Direct experience with manufacturing operations and biotechnology processes is strongly desired. Cross-functional team experience
    • Completely proficient in technical writing and Microsoft Office.
    • Successful track record of completing validation projects.
    • Ability to organize and present technical data and overviews without assistance.
    • Knowledge of Industry guidelines (ISPE especially GAMP 5, PDA), US and international regulations (FDA, ICH, ISO, EU) for GMP regulated environments., standard Operating Procedures, validation requirements, and computerized systems required.
    • Ability to interpret engineering documentation and design specifications a must.
    • Direct experience with manufacturing operations and biotechnology processes is required.
    • Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
    • Ability to be flexible to address both shifting priorities and changes in approach in dynamic work environments.
    • Must be able to solve routine problems without assistance.
    • Complexity and Problem Solving Excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into manageable activities.
    • Must possess basic knowledge of core principles in validation disciplines, as well as be experienced applying project management methodology. Knowledge of basic principles in various engineering disciplines. Internal and External Contacts Interaction with manufacturing, schedulers, maintenance and quality staff to secure equipment allocation in support of execution activities. Interaction with project managers for schedule adherence
    • Displays general understanding
    ... See more
    of theories/practices of a variety of disciplines.
    • Interfaces with customers on technical issues, project timeline, and validation support.
    • Actively participates on cross functional teams to determine the root cause and corrective actions for problems associated with investigations.
    • Makes independent decisions within defined areas of responsibility.
    • Able to multi-task under strict deadlines
    • Strong organizational skills, excellent writing and communications skills.
    • Proficiency with Microsoft office including Word, Excel, and PowerPoint. Microsoft Project and Visio a plus.
    • Bilingual preferred
    Green Cross Biotherapeutics Inc.

    Green Cross Biotherapeutics Inc.

    Established in 2014, GCBT is a Montreal-based biopharmaceutical company and a member of the GC family. Canada’s only IVIG and Albumin Manufacturing Plant GCBT has recently completed the construction of the only intravenous immunoglobulin (IVIG)...

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