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    Validation Engineer - Allentown, United States - Sharp Corporation

    Sharp Corporation
    Sharp Corporation Allentown, United States

    1 week ago

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    Description
    SUMMARY

    Responsible for validation activities at respective Sharp facility. Responsibilities include execution of all validation activities related to equipment, process and facilities qualifications at the direction of the Validation Manager. Scope of work may extend into computer and cleaning validation activities. Validation activities will be performed at all facilities within the guidelines of current good manufacturing practices. Responsible for ongoing contact with Internal Operations, Sales, Engineering, Quality Assurance, and customers regarding validation activities and scheduling.

    Scope of the position includes Macungie or Allentown. Position will be located at one designated site.

    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.

    Support the validation program by contributing to development of validation approach, design and execution.

    Write IQ/OQ/PQ protocols for appropriate equipment and systems within the guidelines of cGMP.

    Write PV protocols specific to customer needs.

    Responsible for communicating validation approach and requirements with customers.

    Responsible for coordinating the execution of validation activities at designated Sharp facility including but not limited to packaging, cleaning, HVAC and computer systems.

    Monitor or execute validation protocols.

    Review executed protocols and write final reports.

    Provide support for customer audits and external regulatory audits specific to validation activity at all Sharp facilities at the direction of the Validation Manager.

    SUPERVISORY RESPONSIBILITIES:

    None. Provide guidance and support to project team members, coordinate the work of Validation Technicians, Operations and Quality staff involved in the execution of validation protocols as necessary.

    QUALIFICATIONS:

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    EDUCATION and/or EXPERIENCE:

    Bachelor's degree in technical discipline (BS/BA) from a four year college or university preferred with three to six years related experience and or training; or equivalent combination of education and experience.
    • Knowledge of current validation principles and industry practices, including FDA regulations, cGMPs, and validation guidance documents is required.
    • Knowledge of basic engineering principles and practices, equipment automation controls, etc. is required.
    • Ability to structure validation protocols in conformance with a planned validation approach is required.
    • Familiarity with quality and attribute sampling plans (e.g. ANSI ZI.4) is required.
    • Excellent written communication skills are required.
    • Ability to plan and schedule validation activities and to multi-task is required. The position requires the ability to work independently and to commit to meet project deadlines.
    • Good oral communication, organizational and planning skills are required.
    • Familiarity with quality engineering practices in manufacturing operations is desired.
    • Relevant ASQ certification is desired.
    MATHEMATICAL SKILLS:

    Basic math skills (addition, subtraction, multiplication and division) are required. Ability to apply complex mathematical operations including, scientific notation, conversion factors and basic statistics, ( mean, standard deviation, regression, etc.) is required. Familiarity with trend analysis, and sampling theory, are required.

    LANGUAGE SKILLS:

    Ability to read, analyze, and interpret common scientific data and technical documents is required. Ability to read and interpret engineering documents and drawings is required. Ability to respond professionally to common inquiries or complaints from customers regarding validation issues is required.

    Ability to effectively present information to the following groups:
    • Internal: Daily contact with Quality Department, Sales, Engineering and Operations Department employees for information exchange, collaboration, problem solving, direction regarding customer validation issues. Frequent contact with Account Executives and/or Project Managers for information exchange and direction regarding customer validation issues.
    • External: Frequent contact with customer representatives planning new product introductions, and problem solving validation issues. Frequent contact with client auditors and regulatory representatives (e.g. FDA, DEA) for inspections, questions related to validation matters as required by the Validation Manager.
    WRITTEN SKILLS:

    Ability to compile technically sound and grammatically correct validation protocols and summary reports is required. Ability to produce clear and concise documentation within forms and memos to file in conformance with basic Good Documentation practices is required. Technical writing skills are required.

    REASONING ABILITY:

    Ongoing contact with internal Operations, Sales, Engineering and Quality Department employees, Customer QA representatives, occasional contact with regulatory personnel concerning compliance with customer requirements as well as cGMP's concerning validation issues. Customer agreements and regulatory guidelines are available to assist, however frequent review and reasonable interpretation are necessary to keep current. Good organizational skills are necessary. Good mental skills for analysis and problem solving are needed. Need an ability to negotiate to reach a common solution meeting everyone's needs.

    COMPUTERS SKILLS:

    Must be proficient in Microsoft Office, Windows O/S Lotus Notes and related software applications.

    PHYSICAL DEMANDS:

    The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this job, the employee is regularly required to use hands to handle or write and to speak and hear. The employee frequently is required to sit. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision, and ability to adjust focus.

    WORK ENVIRONMENT:

    The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

    While performing the duties of this job, the employee is normally required to sit at a desk and regularly go onto the shop floor and to work in close proximity to packaging equipment. The working environment is clean and not normally subject to hazardous environment or conditions.

    Approximately 5 percent auto travel between sites.

    Travel to customers and to equipment suppliers on an as needed basis.

    Prepared by: (Signature/Date)

    Approved by: (Signature/Date)
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