Valeant Pharmaceuticals

  • Validation Engineer

    Location US-FL-Tampa
    Job ID
    10549
    Category
    Operations
    Pos. Type
    Full Time
  • Overview

    Valeant Pharmaceuticals International, Inc. is a diverse pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance. Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help us set goals based on our organization’s potential and what we hope it will become.

     

    This position will perform validation of manufacturing equipment, facilities, utilities and computerized systems associated with the manufacture of pharmaceutical or medical devices to assure compliance with cGMP’s, FDA’s and BLP’s guidelines. Job assignments are to be completed without a considerable amount of supervision or coaching. Assume the responsibility for the cGMPs and Environmental Health and Safety procedure awareness, and compliance within the respective area.

    Responsibilities

    • Develops sound scientific rationale/strategy for qualification/validation of new or modified cGMP equipment, facilities, computerized systems, utilities and processes.
    • Design, implement and execute protocols to quality/validate manufacturing equipment, facilities, computerized systems, utilities in a manufacturing environment following the latest cGMP regulations.
    • Assess and perform process/equipment/systems requalifications to confirm and provide evidence that such systems remain in a validated state.
    • Evaluate test data and write final reports to summarize testing performed. Gather all pertinent documentation required for completing the validation activity.
    • Perform project management duties for limited number of CIP/compliance related projects.
    • Communicate the requirements, scheduling, results and impact of the performance of the above projects to ensure efficient and successful turnover of validated equipment or systems to the customer in support of the manufacture of sterile pharmaceutical     product.
    • Supervision of technicians, contracted and/or temporary employees for related job functions.
    • Identify and participate in continuous improvement projects related to validation programs and procedures.
    • Interface with cross functional teams such as Engineering, Planning, Project Managers, Quality representing validation to help determine impact to validated state and validation strategy for new or modified equipment/systems/facilities.
    • Assist with regulatory audits/inspections.
    • Provide planning and scheduling support to projects while defining validation scope of work, resources, and duration to meet site-wide validation goals.

    Qualifications

    • Bachelor's Degree in Engineering or any Science Disciplined degree.
    • Minimum 3 years of Engineering or Validation experience.
    • Experience in one or all of the following types of validation desired: Utilities, facilities, manufacturing process equipment (compounding, filling, and packaging), sterilization processes including moist heat, dry heat, gamma, and ethylene oxide.
    • Computerized systems/SQA experience is a plus.
    • Strong Project Management, organizational, analytical, computer, writing and communication skills.
    • Knowledge of aseptic processing highly desired.
    • Excellent logical/mechanical aptitude desired.
    • Knowledge of cGMP regulations and latest validation guidelines.
    • Able to handle multiple priorities in a fast-paced environment.
    • Able to work extended/odd hours around manufacturing schedule required.

    Be Aware of Recruiting Fraud

    Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

     

    To learn more please read Valeant’s Job Offer Fraud Statement.

     

     

    Valeant Pharmaceuticals International, Inc. is committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

     

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