• Validation Engineer

    Posting Date 2 months ago(8/30/2018 3:37 PM)
    Requisition ID
    2018-5197
    Job Location(s)
    Pittsburgh PA United States
    Position Type
    Full Time
    Company
    Cook Myosite Inc.
    Category
    Production/MFG/Operations
  • 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.

    Responsibilities

    • Provide direct technical assistance regarding the validation requirements of biopharmaceutical processes, assays, materials, equipment and methods including project management, process design reviews, document generation (VMP, URS, FAT, SAT, IQ, OQ, PQ protocols, SOPs, summary reports), protocol execution, and regulatory filings
    • Conduct equipment factory acceptance tests, install and qualify equipment, author SOPs, train equipment operators, and maintain equipment including routine maintenance and scheduled service
    • Support departments of end-users by writing SOPs
    • Prepare documentation and execute commissioning and validation activities using risk based (FEMA, PHA, etc.) Good Engineering Practices (GEPs) according to industry standards
    • Prepare documentation and oversee analytical method validation and process following industry standards

    • Use statistical techniques to properly design and execute validation activities
    • Analysis process data to identify Critical Quality Attributes (CQAs) and design validation activities to establish acceptable ranges for CQAs
    • Research and implement value adding technology
    • Write, implement and review SOPs and train employees according to SOPs and GMPs
    • Assist in identifying and organizing requirements
    • Develop design testing procedures and coordinate with others to perform tests
    • Support investigations of manufacturing deviations and anomalies
    • 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

    Qualifications

    • Requires Bachelor's degree in the Life Sciences, Engineering and/or direct applicable experience with validation of biopharmaceutical processes and analytical methods
    • Basic understanding of cGMP and aseptic requirements
    • Strong knowledge of GEPs
    • Working knowledge of risk based engineering methods with statistical aptitude
    • Detailed understanding of cGMP quality system principles
    • Working knowledge of word processing, spreadsheet, and database management software

    • Strong communication skills
    • 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 collaborative and  independent work situations and environments with minimal supervision

     

    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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