Sr.Specialist, Bulk Manufacturing Engineer - Technical Operations Rotation Opportunity

Date: Apr 24, 2019

Location: Durham, NC, US

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Requisition ID: PRO018796

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. 

 

This is a rotational assignment initially assigned to technical operations at our West Point, PA site within vaccine bulk processing, then transition to a full-time assignment at our Durham RTP site in support of key vaccine product franchise capital projects to increase vaccine bulk manufacturing capabilities.

The Sr. Specialist, Technical Services in the Bio-Bacterial Manufacturing End-to-End project provides engineering technical support to the manufacture of liquid vaccines while actively supporting, participating in, and embracing an empowered team culture. The Sr Specialist will work as an individual contributor, as well as, a team or project manager to lead work of others as required. 

 

Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Limited off-shift or weekend coverage may be required based on business unit needs and specific assignments. 

The role encompasses technical services support in the areas of equipment and automation systems, validation, deviation management and product franchise. Specific assignments may be focused in one area or span across multiple areas of focus. 

The selected candidate will be responsible for:

  • Serving as single point of contact and SME for tech services for product franchise support for a product or family of products.
  • Leading cross functional teams and acting as individual contributor to drive validation activities, change control and improvement projects across compliance, and strategic, including projects aimed at improving Right-First-Time performance, and value capture projects that seek to improve yield, reduce cost, or lower our processing cycle times. 
  • Authoring and approving Change Control documentation for complex process, validation, equipment, facility/utility and/or automation changes. Managing on-time implementation and close-out to meet project, production and supply timelines. 
  • Preparing source documentation for regulatory filings, supporting and serving as a lead SME during regulatory inspections related to process overviews, investigations, projects and validation.
  • Authoring technical protocols, executing studies and reporting results/conclusions in support of product tech transfers, process improvement projects and deviation investigations. The individual will be required to utilize sound engineering principles to support qualified validation processes as required per current Good Manufacturing Practices (cGMPs).
  • Leading and completing all product Annual Review expectations including authoring Continued Process Verification Reports, including pulling data, generating charts and statistically analyzing the data to identify whether preventative actions are required.
  • Approving new or updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures). 
  • Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process troubleshooting or to provide immediate responses to deviations and/or protocol exceptions.
  • Performing validation assessments for proposed changes impacting the qualified processes.
  • Supporting team safety, environmental, and compliance objectives.
  • Provide in-depth product expertise, support deviation investigations aimed to prevent deviation re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment. Where applicable, complete investigational test protocols to determine root cause, product impact, event scope, etc.
  • Managing investigation, project and validation study timelines to ensure key compliance and customer due dates are met; escalating any potential misses and develop remediation plans when possible. Executing projects and assigned studies in a right-first-time manner.
  • Collaborating effectively with the area Coaches, Operators/Mechanics, support groups (Mechanical Services, Automation, Technology), Quality, and Planning.
  • Actively using and championing the use of Lean Six Sigma (LSS) and Merck Production System (MPS) tools, both in problem solving and day-to-day operational activities
  • #LI-HW2
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.

NSBE2019

Qualifications

Education Minimum Requirement:

  • B.S. in Engineering Field

Required Experience and Skills:
  • Engineering educational background
  • Minimum of 6-year post-Bachelor’s degree experience in vaccines in support of Production, Process Engineering, Technical Services or related experience. 
  • Product franchise tech services experience
  • Experience with tech services support activities for introduction or launch of new product
  • Demonstrated leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills

Preferred Experience and Skills:
  • Experience with validation documentation and execution
  • Experience with Trackwise, MIDAS, SAP, MII, Delta V
  • Experience with change control documentation and execution
  • Experience with Clean-in-Place and Sterilize-in-Place systems
  • Experience with regulatory agency interactions
  • Ability to read Piping and Instrumentation Diagrams is desired
  • Support of deviation investigations and/or project work
  • LSS/MPS certification / experience

#LI-HW2

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 

          OFCCP EEO Supplement

 
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of it’s manifestations.


Job: Process Engineering
Other Locations:
Employee Status: Regular
Travel: Yes, 10 % of the Time
Number of Openings: 3
Shift (if applicable): 1st
Hazardous Materials:
Company Trade Name: Merck


Nearest Major Market: Durham
Nearest Secondary Market: Raleigh

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