Associate Director Engineering, Validation Sterilization SME

West Point, PA, US
April 06 2018
Organization Type
Requisition ID: ENG003782

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 Associate Director ValidationSterilization SME, will be responsible for the oversight of sterilizationprocesses in the the West Point site as part of the Bio-Sterile Validation(BSV) Subject Matter Expert (SME) team. The primary responsibility of the individual will be supportingIntegrated Product Teams (IPTs) involved in vaccine manufacturing.    The AD Sterilization -SME will review and approvevalidation documentation (including but not limited to; validation strategies,detail design, user requirements document) related to new or existingsterilization projects to ensure successful completion is in alignment withwest point validation requirements. Also, when required the AD Sterilization SME will be required to trainand coach junior engineer/specialist in areas such as thermal and sterilizationprocesses.


Additional responsibilities include thefollowing:

  • Responsiblefor defending site and company validation policies/practices in front ofregulatory agencies during inspections and regulatory submissions.
  • Identifyvalidation improvement initiatives for alignment with current validation bestpractices.
  • Generateand approve validation assessment for new or existing changes to sterilizationequipment, utilities and processes.
  • Interfacewith global validation group to ensure sterilization validation practices inwest point are aligned with Merck & Co., Inc. network.
  • Completegap assessments for Merck global guidance and perform remediation activities toensure site compliance.
  • Supportsite IPTs during investigations and troubleshooting as a thermal validation/sterilizationsubject matter expert.
  • Supportnew or existing product regulatory filing requirement and provide subjectmatter expertise review throughout the process.
  • Providesupport to obtain accurate and real time site validation metric to maintain thehealth validation compliance.
  • Identifyvalidation improvement initiatives for alignment with current validation bestpractices.
  • Manage internal/external, indirect/directvalidation scientist/contractors as needed based on the sterilization projectneeds.


Education Minimum Requirement:  

  • BS, Preferably in Engineering or Sciences

Required Experience and Skills:

  • Minimumof 10 years relevant work experience, hands on experience on validationactivities on sterile products manufacturing and/or laboratory operations.
  • Strongknowledge and hands on experience Sterilization, Depyrogenation, VHP,Radiation,  Sterilization in place andsterilizer equipment.
  • Experienceinteracting with regulatory agencies.
  • Demonstratestrong knowledge on different types of sterilization concepts such as but notlimited to: D-Value, Lethality, SAL, Biological indicator and exposure time.
  • Strongcommunication, collaboration skills and ability to drive accountability
  • Strongbackground solving analytical and/or complex problems.
  • Proficiencywith Microsoft Office applications (Word, Excel, Project, PowerPoint, etc.).
  • Experiencecoaching validation contractor(s) and/or direct reports
  • Strongknowledge and hands on experience interpreting guidances/guidelines forsterilization such as but not limited to; BS EN 285, ISO, USP, PDA and AAMI fordifferent types of sterilization.

Preferred Experience and Skills:

  • Minimumof 7 years work experience on different areas of sterilization.
  • Master Degree in Science or Engineering Related Degree
  • Experiencewith Risk-Based Approach to Commissioning and Qualification.
  • Strongexperience working on cross-functional team to achieve common goal.
  • Experiencewriting validation assessment and white paper for sterilization.

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.


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


            EEOC Poster

            EEOC GINA Supplement 

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

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