Senior Engineer, Technical Operations

Employer
Merck
Location
Durham, NC, US
Posted
April 12 2018
Organization Type
Pharma
Requisition ID: CHE005894

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. 


Our ability to excel depends on theintegrity, knowledge, imagination, skill, diversity and teamwork of people likeyou. To this end, we strive to create an environment of mutual respect,encouragement and teamwork. As part of our global team, you'll have theopportunity to collaborate with talented and dedicated colleagues whiledeveloping and expanding your career.

At our Vaccine Facility in Durham, North Carolina, the Global VaccineTechnology & Engineering (GVTE) department is seeking candidates to partnerwith Manufacturing Operations, Quality Operations and Process Automation. GVTEprovides technical engineering and manufacturing support for the production ofMerck's live virus vaccines at Durham.

This is an exciting opportunity for an Engineer to join our VaccineManufacturing Technical Operations department within the Merck ManufacturingDivision (MMD), supporting a sterile fill, finish, and lyophilization vaccinemanufacturing facility.  

 

The Maurice R. Hilleman Center forVaccine Manufacturing is a state of the art facility, started in 2004, formanufacturing Merck's lifesaving vaccines. Due to the importance of thisfacility in Merck’s Vaccine Manufacturing Supply Chain, the facility has seenrapid growth in production volumes and new employees over the last severalyears; currently Durham employs 1,000+ people.

The Technical Operations team is expanding to support both the currentcommercial vaccine production and technical transfer of new Vaccine products tothe Durham facility. The Technical Operation’s team expansion offerschallenging employment and professional growth opportunities for skilledengineers and scientists. The successful applicant will have the opportunity tobecome part of this exciting team supporting the Durham facility.

The Senior Technical Support Engineer within the IPT (IntegratedProcess Team) will be part of a cross functional team charged with thetechnical support of the manufacturing shop floor in a new fill-finish vaccinefacility. This role requires the ability to execute multiple projects andactivities across the IPT. Strong communication and collaboration skills areessential. The successful candidate will also have robust problem solvingskills and a hands-on approach to equipment validation and problem solving,with a bias toward going to see problems for oneself in the field as theyarise. Enthusiasm for continuously learning is a requirement.


Primary Activities:

  • Analyzingcomplex processing problems through critical analytical thinking and thedesign/execution of laboratory/pilot scale experiment
  • Developmentof sound scientific justification for planned material and process andequipment changes.
  • Workingwith the Technology, Automation, and Quality functions to determine thebreadth and scope of investigations to identify the appropriate rootcause, implement corrective actions, complete trending analysis, anddetermine product disposition.
  • Preparingand/or provides guidance and review for regulatory filings, processdescriptions, investigations, and change requests. Acts as a participantin domestic and international regulatory agency inspections.
  • Supportingall quality and safety initiatives.
  • Providetechnical support to manufacturing shop floor for in-process analytics,controls, and troubleshooting.
  • Keepinghis/her supervisor current on the progress of projects, and makingimprovement recommendations on production procedures.
  • Qualifications

    Education:

  • Bachelor degree or higher in an Engineering or Science related discipline
  • Required:

  • Minimum 5 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations or military experience
  • Strong communication, leadership and teamwork skills
  • Preferred:

  • Experience with optimizing and troubleshooting aseptic processing operations such as formulation, filling, and lyophilization
  • Strong foundation of Lyophilization process and equipment knowledge
  • Familiarity with process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies
  • 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 assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to 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: Yes, 5 % of the Time
    Number of Openings:
    Shift (if applicable):
    Hazardous Materials:
    Company Trade Name: Merck

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