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    Validation Engineer - Los Angeles, United States - BioPhase

    BioPhase
    BioPhase Los Angeles, United States

    2 weeks ago

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    Description

    Summary of Job:
    The Validation Engineer is responsible for designing, planning, writing, and executing protocols and studies. This role involves managing, coordinating, facilitating, and implementing process, equipment, software, and product validations and qualifications.

    The focus is on implementing new facilities, equipment, and process improvements, ensuring compliance with policies and procedures, and meeting customer requirements.


    Specific Duties and Responsibilities:
    Develop, implement, manage, and integrate Qualification and Validation plans for all production activities and products.
    Design testing criteria and procedures, including acceptance criteria for validation purposes.
    Perform all aspects of the validation program (URS, DQ, IQ, OQ, PQ).
    Identify risks, process gaps, and quality issues, and mitigate them through validation activities.
    Handle new facility/equipment/process validations, process and equipment changes, and periodic requalification/revalidation.
    Provide validation, engineering, and process expertise for developing new processes.
    Conduct testing, including setup, execution, and data collection.
    Construct and execute controlled experiments.

    Support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents for validation.

    Support the development and update of validation master plans, project plans, SOPs, risk assessments, user requirements, cleaning assessments, and technical assessment reports.


    Requirements:
    Bachelor's degree in science or equivalent work experience.
    3-4 years of experience in a GMP or ISO regulated environment.
    Experience with oligo synthesis manufacturing.
    Ability to interpret regulatory standards (USP and ISO) and develop risk-based decisions ensuring compliance with governance.
    Familiarity with domestic and international GMP regulations (e.g., 21 CFR 210).
    Strong understanding of quality risk management principles, including best practices in risk-based C&Q approach.
    Hands-on experience in developing validation documentation and field execution.
    1-2 years of experience in a quality-related role in a controlled work environment.
    Experience in executing studies and/or validation protocols.
    ASQ certification (CQA or CQE) is a plus.
    Excellent organizational, negotiation, problem-solving, and time-management skills.
    Self-motivated and willing to tackle assignments and development opportunities outside of job scope as needed.
    Ability to interpret engineering and facility drawings (facility layouts, blueprints, material/process flow diagrams, and equipment P&IDs).
    Expert skills in Microsoft Word and PowerPoint, and intermediate skills in Microsoft Excel.
    Understanding of basic statistics, acceptance sampling, and familiarity with statistics software (Minitab and JMP).
    Attention to detail and decisive action capability.
    Ability to work under pressure, manage multiple tasks simultaneously, and meet tight deadlines.
    Excellent interpersonal, written, oral presentation, and verbal communication skills.

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