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    Cleaning Validation Engineer Hybrid - Durham, United States - GMP Pros, Inc.

    GMP Pros, Inc.
    GMP Pros, Inc. Durham, United States

    4 weeks ago

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    Description
    Job Description

    Job Description Salary:

    Cleaning Validation Engineer - Hybrid

    We are proud to be a

    Great Place To Work US - Certified company

    Check out what our employees say makes working here so great
    :

    GMP Pros seeks an experienced

    Cleaning Validation Engineer for a contract/1099 or B to B arrangement.

    Be part of an exciting start-up that supports the world's leading pharmaceutical, medical device, food, and animal health companies. Attain the best of both worlds.

    Gain experience at a company that leads projects for global pharmaceutical companies while enjoying the flexibility, energy, and personal attention that can only be found working in a small, close-knit company.

    Are you a proactive doer?
    Do you need variety and change to keep from getting bored?
    Do you build relationships easily and are you able to communicate information so that it is easily understandable?
    Are you able to add value for clients and anticipate their needs?
    Are you able to add value for GMP Pros and anticipate the needs of your role and business area?
    Do you like working in a team supportive environment where others want to help you succeed?
    Do you try to find a better way for everything because that is the way it should be?
    Do you quickly become an expert in any subject matter you are working in?
    Can you stay motivated and help motivate others in the face of adversity and change?
    Are you resilient?


    THIS POSITION REQUIRES FOOD, PHARMACEUTICAL, ANIMAL HEALTH, OR MEDICAL DEVICE INDUSTRY EXPERIENCE. PLEASE DO NOT APPLY IF YOU DO NOT HAVE EXPERIENCE IN THESE INDUSTRIES.

    We are seeking

    Cleaning Validation Engineers

    with a minimum of 7 years industry relevant experience.

    The Essential Duties

    :

    Support of validation in accordance with Client requirements per Cleaning Validation Program and GxP and regulatory compliance.
    Development and execution of manual cleaning validation (COP) for various manufacturing equipment and packaging lines for liquids and pastes, to include
    :

    Bracket/matrix for worst case approach
    Risk assessment(s)
    Sample location assessment(s)
    Protocol development (verification and validation)
    Parameter definition
    Cleaning reports

    Coordination of cleaning activities with stakeholders and floor support.
    Coordination and oversight of sampling activities with Quality and Microbiology Lab resources.
    Interfacing with Quality Systems for review/approval cycles and relevant Change Control support.
    Regular status and deliverable communications with primary stakeholders and GMP Pros internal stakeholders.
    Proactive risk escalation and management.
    Status report and Steering committee meetings with executive level stakeholders.
    Utilization of GMP Pros internal communication systems and Ways of Work in a project team environment.

    Here are the requirements we are looking for

    :

    Bachelor's degree in an engineering field (Mechanical, Chemical, Biomedical preferred).
    Minimum seven (7) years of proven Cleaning Validation experience in an FDA regulated industry.
    Demonstrated experience with aseptic gowning requirements and clean room qualification.
    Proven understanding of typical lab methods and sampling requirements for demonstrating equipment cleanliness.
    Demonstrated experience with the following systems
    :

    interpreting P&ID's, Process Flow Diagrams, CIP skids, SIP systems, WIP skids, CIP/COP of manufacturing and packaging equipment.
    Proficiency with MS365 and relevant technology.
    Ability to travel for up to one (1) week at a time.
    Demonstrated knowledge and understanding of the Cleaning Validation lifecycle.

    S

    ome other things that would help you stand out to us

    :

    Experience with Liquids and semi-solids manufacturing.
    Audit experience.
    ISPE Pharma 4.0 training specific to validation.
    Self-guided and managed execution of Cleaning Validation program.
    Cleaning Validation experience in a remediation setting.

    Preferred Qualities and Traits
    :


    Must be driven to seek out new opportunities, ask questions and keep pursuing things when information is limited or not given at all.

    Must be able to quickly turn information received into concise verbiage on paper. Complete stories must be told of events that occurred and actions to be taken but should not use "fluff."
    ACTUALLY listen to everyone's input before forming your thoughts or replies. Operators and others in the facility have a wealth of process and product knowledge.

    Some are limited to their specific trade, so it is your job to take their information to the next level and fit it into the bigger puzzle.

    In this fast-moving industry things will change continuously. Must be able to adapt to the changes and continue making progress.
    Must be patient and focused while also having a continuous sense of urgency.
    Must be able to perform work under rigid timelines in support of client success.

    Pre-Employment Requirements

    :

    Pass and maintain pre-contract background check and safety certification, including but not limited to outstanding professional references.
    Subject to motor vehicle report review.
    Maintain valid driver's license and endorsements as required per position.
    Pass pre-contract physical, medical evaluation, and drug screen due to the safety sensitive nature of this position.
    Successfully complete and maintain any required safety certification and testing on an annual basis
    Key Words
    :

    Cleaning Validation, Validation Engineer
    GMP Pros is an Equal Employment Opportunity / Affirmative Employer (EEO/AA) and actively seeks to diversify its work force.


    Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status are strongly encouraged to apply.


    It is the policy of GMP Pros to provide equal opportunity in employment for all qualified individuals regardless of race, color, religion, ethnicity, national origin, ancestry, disability, medical condition, age, citizenship, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, genetic information, military status, veteran status, and any other characteristic protected by law.

    By submitting material for consideration for this position you are attesting that no material or interaction with GMP Pros Team Members establishes any obligation for GMP Pros to hire you.


    If you are hired, you understand that either GMP Pros or you can terminate your employment at any time and for any reason, with or without cause and without prior notice.

    Further, you understand that no representative of GMP Pros has the authority to make any assurance to the contrary.

    By submitting your application for this position, you attest that you have given GMP Pros true and complete information on this application.

    No requested information has been concealed.

    You are authorizing GMP Pros to contact references provided for employment reference checks.


    If any information you have provided is untrue, or if you have concealed material information, you understand this will constitute cause for the denial of employment or immediate dismissal.

    Accessibility
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    :

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    If you want to view the EEO is the Law poster, please choose your language
    :

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    This company participates in the United States Department of Homeland Security E-Verify program. The E-Verify program is an internet-based employment eligibility verification system operated by the U.S. Citizenship and Immigration Services.

    Please use the links provided for important information when applying for work with this company:

    Everify English / Spanish

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