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    Quality Engineer - Worcester, United States - Synectics

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    Description
    Job DescriptionJob Description


    Description:


    Responsible for commissioning and qualification activities associated with capital projects involving the installation and/or renovation of biopharmaceutical process equipment, facilities, and utilities in an FDA/GMP regulated environment.

    Prepare validation test protocols, set validation strategy, perform/coordinate validation testing for capital projects of different complexity in concert with all stakeholders, and analyze/assemble test results to create summary reports as required

    Review new equipment specifications

    Work with appropriate departments and personnel to resolve validation testing issues

    Advise other departments on SOPs related to validation projects

    Maintain 100% on time training

    Execute assigned jobs and tasks according to schedule

    Achieve Site, Department and Group performance metrics

    Complete other special projects and assignments as required

    Comply with all regulatory, corporate, and site quality system procedures, especially safety and cGMPs


    Qualifications :


    BS Degree in engineering, technical discipline or equivalent preferred, with a minimum of 2+ years of experience supporting biologics manufacturing through validation of biologics equipment or processes.

    An understanding of basic unit operations involving cell culture and protein purification is desired

    Working knowledge of bioreactors, sanitary equipment, hygienic piping, process instrumentation and controls is required

    Expertise in Clean-In-Place and Steam-In-Place theory and techniques is preferred

    Experience with risk-based approach to commissioning and qualification preferred

    Experience with temperature mapping of environmental chambers, autoclave validation is strongly required

    Familiarity with distributed control systems and process logic controllers is required

    Must have familiarity with P&IDs, loop diagrams, etc.

    Must have hands-on experience on the Kaye Validator

    Familiarity with project management is preferred

    Experience with risk assessment and system classifications is a plus

    Adherence to cGMP and GDP is required

    Strong technical writing skill is required

    Strong organizational, prioritization, technical, mechanical, and communication skills as well as experience in a GMP environment are preferred

    Must be able to work independently with adequate supervision, multi-task and support several projects simultaneously

    Must demonstrate strong interpersonal and teamwork skills

    Work in a manufacturing environment with:

    awkward/forceful/repetitive

    (arms above shoulder, bent wrists) use of arms

    Work in a clean room environment

    Lift, carry, push or pull weights of more than 20 pounds on a regular basis

    Routine work with chemicals

    Company DescriptionSynectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States.

    We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling.

    We also seek to justify our clients' expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day.

    Our success has depended on our consistent ability to achieve both of these goals.

    Synectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions. The technologies we support have always been responsive to this extremely broad spectrum.

    In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds.

    This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.

    Synectics is an Equal Opportunity Employer.

    Healthcare Insurance:
    Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.

    Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

    Premiums are subsidized by Synectics.

    Dental Insurance:
    Synectics offers eligible employees and their dependents a dental plan through MetLife.

    Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.


    Vision Insurance:
    Synectics offers eligible employees vision insurance through VSP.

    Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.



    Technical Certification Bonus:

    Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.

    In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.

    Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus.

    It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

    Company DescriptionSynectics is one of the nation's foremost consulting firms, working with a client base that includes some of the leading institutions and Fortune 500 corporations in the United States.

    We seek to bring the most highly qualified professionals to assignments that they will find challenging and fulfilling.

    We also seek to justify our clients' expectations that every Synectics consultant will bring the highest possible effort to their endeavors every day.

    Our success has depended on our consistent ability to achieve both of these goals.\r\rSynectics serves an extremely diverse client base which represents an equally diverse range of industries and institutions.

    The technologies we support have always been responsive to this extremely broad spectrum.

    In order to fully engage with this continually changing commercial and technological landscape, our employees must draw on their own varying interests, skills and backgrounds.

    This insight, reflected in our daily practices, has always been our fundamental strength as a company, and it continues to serve us well in all our efforts.

    \rSynectics is an Equal Opportunity Employer.

    \r\rHealthcare Insurance:

    Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois.

    Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

    Premiums are subsidized by Synectics

    \r\rDental Insurance:

    Synectics offers eligible employees and their dependents a dental plan through MetLife.

    Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

    \r\rVision Insurance:

    Synectics offers eligible employees vision insurance through VSP.

    Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

    \r\r

    Technical Certification Bonus:

    \rSynectics is pleased to award its employees a bonus of up to $500 for an approved professional certification.

    In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us.

    Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus.

    It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

    #J-18808-Ljbffr

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