Specialist, Engineering

Employer
Merck
Location
Durham, NC, US
Posted
May 17 2018
Organization Type
Pharma
Requisition ID: CHE005893

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.

The Maurice R. Hilleman Center for Vaccine Manufacturing is located in Durham, NC. This state of the art facility established in 2004, manufactures Merck’s lifesaving vaccines in bulk and finished forms.  Due to the importance of this facility in Merck’s Vaccine Manufacturing network, the facility has seen rapid growth in production volumes and new employees over the last several years; currently Durham employs 1,000+ people.


Durham’s Specialist, Tech Ops COE Process Support Lab will be an energetic, technical contributor with strong interpersonal, communication, and collaboration skills responsible for drug substance process engineering and process development for new vaccine product launch facilities.

Key responsibilities may include but are not limited to;

 
  • Provide process engineering support to new drug substance products intended for new product launch facilities
  • Author technical reports and documents associated with site commercialization efforts
  • Provide technical/team support as required for late stage cell culture process development, scale-down model development/execution/implementation, process characterization, commercial technology transfer, and qualification studies associated with the development and implementation of bulk processes, systems and facilities related to vaccine bulk products
  • Support definition and development of process control strategy including identification of critical process parameters and critical material attributes for upstream process and raw materials
  • Participate in the equipment specification, selection/procurement, and qualification phases of a project
  • Actively participate on cross-functional manufacturing teams to advance projects goals and deliverables related to the drug substance process
  • Author technical documents to support regulatory filings including technical reports and risk assessments
Qualifications

Education Minimum Requirement:
  • Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related field with a minimum of two (2) years of relevant experience.
Required Experience and Skills**:
  • Experience in vaccine or biologics drug substance manufacturing within an aseptic, cGMP environment
  • Experience authoring technical documentation within a cGMP context.
  • Proven technical communication (written & presentation) skills
  • Experience with project strategic plan development and management
Preferred Experience and Skills:
  • Hands-on expertise with lab or pilot-scale culture process (fermenters, bioreactors, static cell culture) and/or with large molecule purification (chromatography, filtration, centrifugation)
  • Technical knowledge and experience with cell culture, virus propagation, and/or large molecule purification
  • Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations 
  • Experience in new product introduction and technology transfer
  • Experience with process control systems, e.g. Distributed Control Systems
  • Ability to provide scientific mentorship and guidance to technical colleagues
  • Lean Six Sigma belt certification
  • Experience with Quality by Design (QbD)
  • Working understanding of process risk assessment tools
  • Experience authoring technical documents supporting regulatory filings (IND, BLA)
  • Experience with responding to regulatory questions with multiple agencies (FDA, EMA, JNDA,)
  • Experience with face to face presentation of technically complex subjects to regulatory inspectors 
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:

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Job: Chemical Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Hazardous Materials: yes
Company Trade Name: Merck