Specialist Engineering CTU SME

West Point, PA, US
April 13 2018
Organization Type
Requisition ID: ENG003781

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.  Position Description 

TheValidation Specialist, Engineering, will be responsible for the oversight thecontrolled temperature mapping (CTU) practices in the West Point site as partof the Bio-Sterile Validation (BSV) Subject Matter Expert (SME) team.  The primary responsibility of theindividual will be supporting Integrated Product Teams (IPTs) involved invaccine manufacturing.   Also, whenrequired the Validation Specialist will be required to train and coach juniorengineer/specialist in areas such as temperature mapping for freezer, coldvaults, warehouse and laboratory temperature units.

 Additionalresponsibilities include the following:

  • Generate and approve validation assessment forchanges to validated state of control for equipment and component
  • Support site troubleshooting activities duringinvestigation and process improvement activities.
  • Complete gap assessments for Merck global guidanceand perform remediation activities to ensure site compliance.
  • Support site IPTs during investigations as a controlledtemperature mapping subject matter expert.
  • Support and oversee CTU revalidation metrics forsite compliance
  • Support implementation of new Units (e.g. sitecapital projects) by reviewing and approving validation related documentswhen required to ensure West Point compliance.
  • Support/present validation documentation toregulatory agencies during inspections and regulatory submissions.
Supportnew or existing product regulatory filing requirement and provide subjectmatter expertise review throughout the process.Qualifications

Position Qualifications: (please provide below)
Education Minimum Requirement: BS, Preferably in Engineering or Sciences

Required Experience and Skills**:
•Minimum of 2 years relevant work experience in pharmaceutical/biologics qualification.
•Experience calculating and interpreting data from validation studies
•Strong communication, collaboration skills and ability to drive accountability
•Strong background solving analytical and/or complex problems
Preferred Experience and Skills:
•Minimum of 2 years work experience working with controlled temperature units programs for manufacturing and/or laboratory operations.
•Demonstrate strong knowledge on different types of control temperature units and temperature mapping conceptsExperience interacting with regulatory agencies
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: 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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