Compliance Team, Inc.

  • Sr. Validation Engineer

    Job Locations US-IL-Kankakee
    Posted Date 5 days ago(8/9/2018 11:57 AM)
    ID
    2018-1246
    # of Openings
    3
    Category
    Engineering
  • Overview

    Compliance Team, Inc. is a leading provider of technical consulting services to our clients in the pharmaceutical, biotechnology, and medical device industries in the areas of commissioning, qualification, validation and regulatory compliance.  We are proud of our talented professionals and the major contributions they make to our clients’ successes on mission critical projects. 

     

     

    Become part of our team! We have  three exciting opportunities for Senior Validation Specialists.  We seek top-notch professionals with project management experience to provide implementations for critical systems in a sterile, injectable pharmaceutical manufacturing setting. 

     

    Responsibilities

    This posting relates to three roles, who will collaborate on a team executing Installation, Commissioning and Qualification for a new pharmaceutical manufacturing/processing facility.  These roles will act as project "Co-Managers," providing the necesssary services and also providing regular project updates to site management.  These three roles will also oversee more junior validation engineers, and ensure coverage over the full scope of work.  The three subject matter experts needed for the Senior roles include the following:

     

    Role 1: Mechanical Expert in Biopharmaceutical Manufacturing Systems

    This individual will be responsible for the design, installation, commissioning, and qualification of bio-therapeutic manufacturing systems and equipment, within an FDA-regulated, GMP setting.

     

     

    Role 2: Automation Expert to Support Biopharmaceutical Manufactruring

    This individual will be responsible for programming and design of process control systems and automation that drive bio-therapeutic manufacturing systems and equipment (Siemens PCS7, experience preferred).  This individual will also follow through with installation, commissioning, and qualification of the software/hardware and firmware for the automated systems, within an FDA-regulated, GMP setting.

     

     

    Role 3: Operations Expert in Biopharmaceutical Manufacturing

    This individual will be responsible for designing manufacturing processes related to operating bio-therapeutic maufacturing systems and equipment, and ensuring that equipment design supports operational needs.  Furthermore, this individual will participate in the installation, commissioning and qualification process for the operations system to ensure equipment suitability for its intended use. 

     

    Qualifications

     Desired Skills and Experience:
    The following listed requirements need to be met at a minimum:

     

    • Bachelor degree in Engineering, Science, Computer Science, or related field with commensurate experience
    • Fluency in English and strong technical writing and good documentation practices
    • 12+ years' experience in the area of subject matter expertise
    • 7+ years' experience in the commissioning and qualification of cGMP facilities
    • Knowledge of FDA regulations and pharmaceutical GMPs
    • Excellent self-management, time management, and problem-solving skills, with ability to prioritize activities effectively.
    • Ability to function in multidisciplinary teams, possessing excellent documentation, presentation, training, and computer skills
    • Familiar with pharmaceutical manufacturing process, facilities and equipment, calibration, IQ, OQ, PQ, and development of SOPs
    • Must be willing to work at the project site on a full-time basis (travel expenses, if necessary, will be reimbursed)

    In addition to the above technical competencies, ideal candidates will have a commitment to deliver quality service with outstanding interpersonal, oral, and written communication skills. Candidates must be results-oriented, able to make decisions, and able to prioritize work per business needs. Strong communication, organization, and time management skills are necessary. Desired skills include: teamwork, leadership, ability to maintain constructive relationships with personnel from various disciplines at all levels in the organization. The successful candidate should demonstrate integrity, reliability, dedication, adaptability, innovation, and self-motivation. 


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