Halo Pharmaceuticals

  • Supervisor Validation

    Job Location US-NJ-Whippany
    Type
    Regular Full-Time
  • Overview

    The Supervisor Validtion is responsible for all segments of the process, packaging and cleaning validation function. Responsible for supervising, developing and implementing validation processes to ensure products meet with appropriate regulatory agency validation requirements, internal company standards and current industry practices. Oversees and reviews validation area processes and procedures, making recommendations for changes and/or improvements. Aligns group activities and priorities with the organization's strategic plan.  Based on significant technical expertise, reviews and approves complex design concepts and provides general direction to technical staff.

     

    Responsibilities

    • Responsibilities also include oversight for the development, completion, logging and archiving of documentation on protocols, Validation Master Plans, and Validation Summary Packages.
    • Prepare and approve Process Performance Qualification, Packaging Validation and Cleaning Validation protocols, reports and support documentation (engineering change requests, system change forms, etc.) in order to secure project release.
    • Responsibilities include directing or participating in performing technical failure analysis of processes/product not meeting specifications, developing statistical process control programs to monitor processes, reporting on trends to reduce product/process variability.
    • Applies statistical analysis and design of experimental approaches to process development activities.
    • Develops and administers budgets, schedules and performance requirements.
    • Coordinates activities of personnel in other departments and contractors as well as providing day to day guidance to the Validation staff. Acts as advisor to subordinates to meet schedules and/or resolve technical problems.
    • Participates in regulatory and client audits with respect to the validation discipline
    • Supervise, identify, hire, develop and recognize technical staff; Create and maintain employee and organizational development; as well as HR plans which meet business needs.
    • Apply specialized knowledge in a creative way to a broad range of difficult problems.
    • Supervision of Validation Specialists
    • May remain in a sedentary position 50% of the time
    • May be required to move about the facility
    • Other duties as assigned.

    Qualifications

    • Requires excellent analytical skills with systematic approaches to problem solving. Must be able to break down complex problems and tasks into activities capable of being performed by personnel. Also must be able to identify subtle discrepancies in processes or products and have good judgment in determining impact and potential risk
    • Ability to communicate effectively at all levels in verbal and written form, including technical/business writing. Able to manage multiple cross-functional teams simultaneously.
    • Proficient in Microsoft Word and Excel, computer software.
    • Sound industry knowledge, project proficiency, and autonomy expected. May be considered a Subject Matter Expert (SME) in various disciplines.
    • Knowledge of GMPs, FDA guidelines, and process and cleaning validation.
    • Ability to manage multiple cross-functional teams simultaneously.
    • Ability to design and influence outside of immediate scope of responsibility.

     

     

    EDUCATION:  

    Minimum of a BA or BS preferably in the Life Sciences/Engineering/Math/Chemistry or other job-related discipline.

     

    EXPERIENCE:

    A minimum of 7-10 years related experience in validation within a pharmaceutical, biotech, devices, or related industry.

     

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