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Bethlehem

    Validation Engineer - Bethlehem, United States - Sharp Services Inc

    Sharp Services Inc
    Sharp Services Inc Bethlehem, United States

    4 weeks ago

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    Description
    Responsibilities include execution of Validation and Qualification Protocols related to equipment, computers and facilities with execution and/or supervision of Quality Associates or Electrical Engineers in their execution of Validation Protocols related to packaging

    processes.

    Secondary responsibilities include drafting Validation Qualification Protocol Events related to equipment, process and facilities.

    In addition the position may require drafting Summary Reports for executed protocols under the supervision the Director, Quality Assurance & Compliance.

    The duties of this position directly impact company compliance to regulatory requirements and customer satisfaction.
    Essential Duties and Responsibilities
    The following is a list of minimum responsibilities related to this position. Other duties may be assigned.

    Generate and execute, with the support of key stakeholders, validation protocols, qualifications protocols and summaries inclusive of design qualification, installation qualification, operational qualification and performance qualification, as appropriate.

    Performs quality engineering reviews of design documentation for compliance with stated requirements including vendor quality manuals and company quality records
    Ensure all validation activities are up to date in accordance with Good Validation Practices and cGMP.
    Review maintenance requests and work orders to assess impact of work to existing qualified state.
    Support key internal stakeholders on review of new equipment, process, and system requests and assess for validation requirements.
    Participate in customer audits and regulatory inspections.
    Author, review and/or approve SOPs and policies related to validation processes and equipment.
    Draft Confirmation of Changes for appropriate equipment, systems, and processes within guidelines of cGMP and GAMP
    Maintain compliance with cGMP and all competent authority guidelines by regularly reviewing and adhering to SOPs

    Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry.

    We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands.

    We've built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products.

    Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery.

    Our clinical services division is one of the world's leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain.

    Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.

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