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Warminster

    Validation Engineer - Warminster, United States - System One

    System One
    System One Warminster, United States

    3 weeks ago

    System One background
    Description

    Title:
    Automation Validation Engineer - Pharmaceutical

    Location:
    Warminster, PA

    Type:

    6 Month Contract potential for extension or hire

    Schedule:
    Mon-Fri Day


    Overview:


    Growing Pharmaceutical Company is seeking an Automation Validation Engineering Professional to develop and execute validation plans and tests for new pharma processing equipment.

    The ideal candidate will have a strong background in validation methodologies, experience in the pharmaceutical industry, and experience crafting processes and validation protocols.


    Responsibilities:


    Develop and execute validation protocols for pharmaceutical equipment, including systems and software validation, in accordance with regulatory requirements such as FDA, EU GMP, and ISO standards.


    Collaborate with cross-functional teams including engineering, quality assurance, and regulatory affairs to ensure validation activities are completed effectively and efficiently.

    Perform risk assessments to identify potential hazards and develop mitigation strategies for validation activities.

    Conduct testing and analysis to verify that equipment meets performance specifications and functional requirements.

    Generate comprehensive validation documentation, including protocols, reports, and traceability matrices, ensuring accuracy and compliance with regulatory standards.

    Provide support during regulatory inspections and audits by presenting validation documentation and addressing any inquiries related to validation activities.


    Stay informed about industry trends and regulatory changes related to validation practices and implement best practices to continuously improve validation processes.


    Qualifications:
    Bachelor's degree in engineering, pharmaceutical sciences, or related field; advanced degree preferred.


    Minimum of 5 years of experience in developing validation plans and protocols within the pharmaceutical industry, preferably in equipment manufacturing or OEM environment.


    Strong understanding of regulatory requirements for pharmaceutical validation, including FDA 21 CFR Part 11, EU Annex 11, and GAMP guidelines.

    Proficiency in validation methodologies such as IQ/OQ/PQ, risk assessment, and validation lifecycle management.

    Experience with validation of complex systems and software applications used in pharmaceutical equipment.

    Excellent analytical and problem-solving skills, with the ability to troubleshoot technical issues and propose effective solutions.


    Exceptional communication skills, both verbal and written, with the ability to effectively collaborate with cross-functional teams and communicate complex technical concepts to non-technical stakeholders.

    Detail-oriented with a commitment to producing high-quality validation documentation that meets regulatory standards.

    Ability to work independently with minimal supervision and manage multiple projects simultaneously

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