Associate Director, BioSterile Validation

Durham, NC, US
April 11 2018
Organization Type
Requisition ID: CHE005879

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. 

As part of the MerckManufacturing Division (MMD), Durham BioSterile Validation is seeking a highlymotivated individual to partner with the Operations, Quality Operations, TechnicalOperations and the Focus Factory to meet the targeted supply and complianceinitiatives within the Durham manufacturing site.  Specifically, you will be responsible forproviding validation support in the production of current and new vaccines inthe Global Vaccine and Sterile Manufacturing organization.


In this role you will:

  • Lead execution of validation PQ activities forboth new and inline products.
  • Lead teams to efficiently accomplish projectgoals.
  • Provide documented evidence that processes areconsistent and reliable through challenges against pre-establishedcriteria.  
  • Lead validation activities associated with thedevelopment of new products, processes, systems, and facilities andsupport of existing and new products, processes, and facilities. 
  • Provide technical support, develop/executeproject plans, and obtain and analyze relevant data and preparesappropriate reports for regulatory commitments and validation improvementinitiatives.
  • Identify and implement technology-driven productivity improvements. 
  • Supervise and guide technical and/or contract staff.
  • Prepare and/or provide review and guidance for regulatory filings,process descriptions, atypical process reports, and change requests.
  • Support all quality and safety initiatives
  • Provide contributions to the planning, design, and implementationof segments of new or upgraded facilities and equipment in a costeffective and timely manner.
  • Design validationstudies, author and approve protocols, and ensure alignment with corporatestandards and guidance for validation.
  • Serve as a mentorfor less experienced employees in the BSV team, assisting them in theirtechnical development.
  • Develop technicaland manufacturing documents necessary for engineering studies, processdemonstration, and validation.
  • Lead facilitystartup and process demonstration activities, primarily development andperformance qualification (PQ) through process validation, workingalongside operations team members to develop reliable, consistentmanufacturing processes that meet cGMP requirements.
  • Author regulatorysubmissions and present your work to multiple regulatory agenciesthroughout the pre-approval inspection processes.
  • Leadtroubleshooting and effectively resolve validation investigations. Developand implement corrective actions to unplanned (atypical) manufacturingevents to ensure a consistent and reliable supply and prevent recurrence.The successful candidate should be able to examine an issue from diverseperspectives (safety, compliance, automation, equipment, process, andpeople) in order to best understand and resolve it at root cause.  
  • Maintainalignment with internal technical personnel regarding validation practicesfor products, processes and equipment.
  • Partner with Operations, Quality, and Automationfunctional areas on validation study implementation.
  • Qualifications

    Education Minimum Requirement: 

  • B.S. in Engineering or Science

    RequiredExperience and Skills:

  • A minimum of 8 years direct validation experience (B.S. degree), 6 years validation experience (M.S. degree), or 3 years validation experience (Ph.D. degree) in biological, pharmaceutical, or chemical manufacturing support roles.
  • Preferred Experience and Skills:  

  • Demonstrated ability to work both independently and as a part of a team
  • Experience leading small groups in a GMP environment
  • Familiarity with regulatory requirements
  • Experience interacting with regulatory agencies
  • Strong technical problem-solving abilities
  • Demonstrated effective written and verbal communication skills; ability to influence both peers and management in building consensus
  • Strong collaboration and leadership skills
  • Sterilization validation (SIP, autoclaves, depyrogenation, VHP, gamma)
  • Cleaning validation (CIP, COP, manual)
  • Controlled Temperature Unit validation (warehouses, incubators, freezers, refrigeration units)
  • Other validation experience in support of process demonstration (IQ/OQ/PQ, shipping, transportation, container closure, sterile filtration, PPQ)
  • Sustaining the validated state through change management and continuing validation studies

  • 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


    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.


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    Job: Chemical Engineering
    Other Locations:
    Employee Status: Regular
    Travel: Yes, 5 % of the Time
    Number of Openings:
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    Company Trade Name: Merck