Compliance Team, Inc.

  • Validation Engineer

    Job Locations US-IL-Kankakee
    Posted Date 5 days ago(8/9/2018 4:07 PM)
    ID
    2018-1247
    # of Openings
    4
    Category
    Validation
  • 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 exciting opportunities for Junior Installation/Commissioning/Qualification Specialists.  We seek top-notch professionals to provide implementations for critical systems in a GMP pharmaceutical setting. 

     

     

    Responsibilities

    There are four roles associated with this posting:

     

     

    Role 1: Mechanical

    Under the direction of a senior mechanical specialist,  perform design, installation, commissioning and qualification of bio-therapeutic manufacturing systems and equipment and cGMP facilities in an FDA-regulated pharmaceutical environment.

     

     

    Role 2: Automation 

    Under the direction of a senior controls system specialist, design, commission, and qualify control systems and automation of bio-therapeutic manufacturing systems and equipment (Siemens PCS7, experience preferred) in an FDA-regulated pharmaceutical GMP environment.

     

     

    Role 3: Operations

    Under the direction of a senior Operations specialist design operations for bio-therapeutic manufacturing systems and equipment assist with installation and qualification of cGMP facilitites in an FDA-regulated pharmaceutical environment. 

     

    Role 4: General

    Under the direction of project leaders, assist with design, installation, commissioning and qualification of cGMP facilitites, biotherapeutic manufactuing equipment and control systems in an FDA-regulated pharmaceutical environment. 

     

     

    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
    • Fluent in English
    • 5+ years experience in the subject matter of specialization
    • 3+ years experiece in the commissioning and qualification of cGMP facilities. 
    • Knowledge of FDA regulations and pharmaceutical GMPs
    • Excellent self-management, time management, and problem-solving skillst.
    • 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 onsite at the location full-time (travel will be reimbursed, if necessary)

    In addition to the above technical competencies, ideal candidates will have a commitment to deliver quality documents and service along with outstanding interpersonal, oral, and written communication skills. Candidates must be results-oriented. 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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