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Validation Specialist

Karwell Technologies

  • Cambridge, MA
  • 30+ days ago

    Highlights

    Job Description: This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area. Experience developing, executing, and reviewing: Validation protocols and reports, Risk assessments (FMEA, impact assessments), SOPs, deviation investigations, and CAPAs.

    Numbers & Facts

    LocationCambridge, MA

    Description

    Job Description:
    • This role will focus on the Computer System Validation (CSV) activities for enterprise GxP systems, specifically for a critical set of projects in the Cell Therapy functional area.
    • This role will be supporting validation leads to help ensure the required deliverables and testing are complete according to the Client CSV SOP.
    • Effective communication is key across a multi-functional team consisting of Business, IT, and Quality personnel.
    • Experience with current digital validation tools is required, use of AI as an accelerator is a plus.
    • Overall a solid CSV background and having a strong work ethic in an aggressive project setting will be key to being successful in this role.
    Roles & Responsibilities:
    • Support creation, review, and approval of all CSV deliverables for custom in-house solutions.
    • Maintain close communication with stakeholders and team members to keep apprised of CSV needs, interpretation of requirements, impacts on compliance of an application, project status, and other relevant issues
    • Ability to create documents to an existing document standard
    • Obtain and respond to review by Business, IT, and Quality stakeholders
    • Follow SOPs and industry best practices
    • Advanced knowledge of complete MS Office suite and Visio.
    • Firm understanding of technology platforms as needed for project.
    • Experience with electronic document management systems (e.g. Qumas, SharePoint etc.); application development and lifecycle management (e.g. ALM, Jira, etc.); and IT service management systems (e.g. ServiceNow)
    • Excellent oral and written communication skills in English. Strong expertise and ability to interview and accurately interpret communication requirements of team members.
    • Familiarity with using AI as an accelerator for creation and review of documents and testing.
    Requirements:
    • Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific or technical discipline
    • 8-10+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments
    • 5+ years of experience in Data Integrity/ALCOA+ principles
    • 5+ years of experience with CSA principles
    • 5+ years of experience with technical writing
    • Working knowledge of GMP, GLP, and GAMP 5 principles
    • Strong understanding of FDA regulations, ICH guidelines, and EU Annex 11 (as applicable)
    • Experience developing, executing, and reviewing: Validation protocols and reports, Risk assessments (FMEA, impact assessments), SOPs, deviation investigations, and CAPAs
    • Ability to support regulatory inspections and audits (FDA, EMA, internal, or client audits)
    • Strong technical writing skills with attention to detail and data integrity
    • Proficiency with common pharmaceutical documentation systems and tools (e.g., EDMS, change control systems)
    • Excellent organizational, communication, and cross functional collaboration skills
    • Cross-functional experience in one or more regulated areas (i.e. Research, Analytical/QC, QA, Engineering, Manufacturing, Regulatory, IT etc.) is desired.
    • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
    • Excellent interpersonal skills, including written and verbal communication.
    • Strong sense of ethics, diplomacy and discretion.
    • Commitment to Quality.
    • Strong critical thinking to analyze complex situations and discern critical issues.
    • Able to work effectively with highly-matrixed and multi-cultural workforce and build strong relationships by being transparent, reliable and delivering on commitments.
    • Excellent team player attitude.
    • Ability to manage competing priorities.

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