• Validation Analyst (IQ, OQ, PQ)

    System One (Bethesda, MD)


    VALIDATION ANALYST (IQ, OQ,PQ)

    US CITIZENSHIP REQUIRED

    100% REMOTE

    HOURLY RATE: $40/HR range. W2, Benefits Available

     

    ALTA IT Services has a contract opening for a Validation Analyst to join our client in a 100% remote role supporting EST work hours. This is a 6+ month project.

    Duties and Responsibilities:

    + Develop and execute validation protocols (IQ, OQ, PQ) for equipment, systems, or processes.

    + Perform risk assessments and define validation strategies based on system impact.

    + Document validation activities following regulatory standards (e.g., FDA, EMA, GxP, 21 CFR Part 11).

    + Collaborate with cross-functional teams (QA, IT, Manufacturing, Engineering) to gather requirements and ensure validation readiness.

    + Support audits and inspections by providing validation documentation and responses.

    + Maintain validation lifecycle documentation, including validation plans, reports, deviations, and change controls.

    + Track and manage validation deliverables and timelines for projects.

    + Stay current with industry best practices and regulatory changes

    Required Skills/Certifications:

    + Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field.

    + Experience in validation (equipment, process, software, or computer systems).

    + Familiarity with regulatory guidelines (GxP, 21 CFR Part 11, Annex 11, etc.).

    + Strong analytical, documentation, and problem-solving skills.

    + Attention to detail and ability to manage multiple validation projects.

    + Excellent communication and organizational skills

    Preferred Skills/Certifications:

    + Experience with computerized system validation (CSV).

    + Knowledge of validation in regulated environments (e.g., pharmaceutical, biotech, medical devices).

    + Proficiency in validation tools and documentation software.

    + Relevant certifications (e.g., ISPE, ASQ, or CSV certifications).

     

    Min Citizenship Status Required: US Citizen

     

    HOURLY RATE: $40/HR range. W2, Benefits Available

     

    Ref: #855-IT Baltimore

     

    System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

     

    System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.