• Validation Engineer

    Posting Date 5 months ago(8/30/2018 3:37 PM)
    Requisition ID
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Cook Myosite Inc.
  • Overview

    Cook MyoSite Incorporated, a division of Cook Incorporated, is a growing, forward-thinking biotechnology organization seeking a full time Validation Engineer.  The Validation Engineer is responsible for the successful planning, design, execution and control of the integration and technical transfer of equipment, materials, processes, assays and methods. This person will be responsible for executing validation projects in the biopharmaceutical industry.


    • Provide direct technical assistance regarding the validation requirements of equipment, systems, and facilities including project management/coordination, study design, protocol development (IQ, OQ, PQ), data analysis and summary report development
    • Author SOPs, train end-users, and maintain systems including periodic requalification and providing technical support to the Equipment Department during scheduled and unscheduled maintenance/calibration activities
    • Design validation studies using risk based (FMEA, PHA, etc.) principles and Good Engineering Practices (GEPs) according to industry standards
    • Troubleshoot and/or investigate deviations which occur either during validation execution or during an assets lifecycle in which data may suggest the system is not operating as intended
    • Use statistical techniques to properly design and execute validation activities
    • Assist in identifying and organizing requirements (URS)
    • Understand and comply with industry standards including International Society for Pharmaceutical Engineering (ISPE), Parenteral Drug Association (PDA), and United States Pharmacopeia (USP)
    • Maintain regular and punctual attendance
    • Must maintain company quality and safety standards


    Minimum Work Experience/Educational Requirements:

    • Requires BS in the Life Sciences, Engineering and direct applicable experience with validation of systems
    • Strong knowledge of GEPs
    • Working knowledge of risk based engineering methods
    • Detailed understanding of cGMP quality system principles
    • Working knowledge of word processing, spreadsheet, and database management software
    • Technical writing experience
    • Able to work with minimal supervision
    • Ability to work with suppliers on technical specifications and procurement details
    • Willingness to work with a “hands-on” approach in commissioning, qualification and validation activities.
    • Must work and interact effectively and professionally with others
    • Must have effective oral and written communication skills
    • Excellent problem-solving skills and ability to work in both collaborative and independent work environments


    Physical Requirements:

    • Must be able to sit at desk, in meetings and/or work on a computer
    • Physically capable of standing, stooping, kneeling, climbing, reaching, twisting and bending with or without reasonable accommodation
    • Climbing a mobile ladder and/or other types of ladders on occasion with or without reasonable accommodation
    • Must perform PPE gowning procedures to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) and appropriate shoes required on occasion

    • Potential limited exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II
    • Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required
    • Ability to work under specific time constraints
    • Laboratory, warehouse and office setting


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