Validation Specialist Job

Employer
Merck
Location
Elkton, VA, US
Posted
October 12 2017
Organization Type
Pharma
Requisition ID: CHE005566

Merck & Co., Inc. Kenilworth, N.J., U.S.A. known as Merck in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where Merck has codified its legacy for over a century. Merck’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.



Merck Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. 


 


At Merck’s manufacturing campus in Elkton, Virginia, we currently have a Specialist, Engineering position within the Technical Services team. The manufacturing facility is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains – just a short distance from the University of Virginia and James Madison University. 


 


The successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of pharmaceutical/biopharmaceutical/vaccine product manufacturing facilities. 


 


Assignments and duties will include: 



  • Achieve Safety, Quality, and Environmental compliance excellence in all assignments

  • Learning new processes and procedures

  • Leading and conducting technical investigations and analyses, recommending corrective actions, and seeing them through to successful, sustainable implementation (specifically in the areas of Filter Functionality / Integrity Testing, CPV, CIP, and Sterilization / Decontamination / CTU Validation)

  • Writing, reviewing, improving documentation for technical and regulatory compliance excellence (specifically in the areas of Filter Functionality / Integrity Testing, CPV, CIP, and Sterilization / Decontamination / CTU Validation)

  • Contributing to process and equipment safety reviews

  • Teaching, coaching, mentoring, and learning from team members

    Qualifications

    Education::



    • B.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and 2-4 years of relevant industrial experience

    OR



    • M.S. degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline and a minimum of 2 years of relevant industrial experience

    Required:



    • Strong problem solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field. 

    • Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required. 

    • The ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it. 

    • Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications. 

    • A willingness to work as a contributing member of a dynamic team of individuals.

    Preferred:



    • CIP / SIP / Sterilization Validation experience

    • Manufacturing environment experience

    • FIT experience

    • Experience working in a cGMP environment

    • Biologics or vaccine processing experience

    • Sterile processing experience

    • Small molecule / API experience


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    Your role at Merck is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At Merck, we’re inventing for life. 


     


    If you need an accommodation for the application process please email us at staffingaadar@merck.com.


      


    Search Firm Representatives Please Read Carefully: 


    Merck & Co., Inc. is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at Merck via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck.  No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means.


     


    Visa sponsorship is not available for this position.


     


    For more information about personal rights under Equal Employment Opportunity, visit:


     


                EEOC Poster


                EEOC GINA Supplement 



    Job: Chemical Engineering
    Other Locations:
    Employee Status: Regular
    Travel: No
    Number of Openings:
    Shift (if applicable):
    Hazardous Materials:
    Company Trade Name: Merck