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    Validation Engineer - De Pere, United States - PharmEng Technology Americas

    PharmEng Technology Americas
    PharmEng Technology Americas De Pere, United States

    4 weeks ago

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    Description
    Job Description

    Job Description

    PharmEng Technology has been providing quality services to leading manufacturers of healthcare and pharmaceutical products since 1997.

    Our specialists hold expertise in Commissioning and Qualification, Validation, Quality Systems, Regulatory Affairs, Engineering, and Training to ensure that our clients can keep on providing the world with their cost-effective and high-standard healthcare products.


    Job required Qualification:
    Bachelor of Science degree, Engineering, or Equivalent training and experience.
    More than 5 years of experience in a regulated environment.
    3 years of experience authorizing procedural and commercial marketing documents.
    More than 3 years of experience with clean rooms, aseptic suites, single-use technology, bioreactors, and cell culture.
    Experience in mechanic and Industrial engineering
    Strong working knowledge of pharmaceutical industry regulations (GMP, GDP, ICH, etc.)
    Strong understanding and working knowledge of project lifecycle, entrepreneurial mindset, and excellent written and verbal communication skills.
    Strong relationship management, leadership, and organizational skills.
    Strong working knowledge in Microsoft suites, and Smartsheet.


    Job responsibilities and Duties:
    Develop and execute equipment qualification protocols for all manufacturing, processing, and packaging equipment and

    facilities/utilities

    supporting these operations.

    Develop and execute process validation protocols for all manufacturing and packaging processes of commercial products (and R&D products as applicable).

    Develop and execute

    validation/verification

    protocols for all commercial and R&D manufacturing, processing, and packaging equipment.
    Analyze data, utilizing statistical methods, generated by validation studies performed by the Validation group to determine process capabilities.

    Gather photocopies and compile relevant documentation such as executed batch records, certificates of analysis, equipment logs, equipment qualifications, raw material certificates of analysis.

    Investigate and resolve

    deviations/exceptions

    from the predefined acceptance criteria.
    Draw conclusions from data, observations,

    deviation/exception,

    and investigation as to whether the process is considered valid.
    Write summary reports (closeout report when applicable) for

    validation/qualification

    protocols following criteria as outlined within the

    validation/qualification

    procedures and policies.

    Maintain protocols and system documentation in an orderly library so that information can be provided to regulatory bodies in a timely manner.

    Ensure protocols, verifications, validation plans, and summary reports generated during validation/ qualification activities are stored according to the procedure.
    Maintain current knowledge in the areas of compliance and validation and other regulatory issues that may impact the Company. Work proactively to maintain the highest level of compliance in all areas. Gather current knowledge from QA/QC, regulatory, periodicals, and/or appropriate training programs.
    Interact and coordinate compliance efforts with other departments including, but not limited to, Operations, Engineering, QA, laboratories (QC and R&D), and R&D to provide a high degree of assurance that all

    qualification/validation

    activities, where appropriate, are completed.
    Adhere to all cGMPs,

    compliance/regulatory

    mandates and quality requirements.
    Perform other related duties as assigned to meet departmental and Company objectives.

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