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Director of Engineering

Merck


Location:
West Point, PA
Date:
08/30/2017
2017-08-302017-09-29
Job Code:
CHE005502
Merck
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Job Details

Job Title: Director of Engineering  - CHE005502

Description

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. 


I. GENERAL SUMMARY:

The Director, Technical Operations, is responsible for the oversight of one or more of the major technical teams within the technical organization at the West Point site.  The primary responsibility of the Director is leadership of one of the teams executing and directing production process performance, process validation and technical transfer, sterilization and cleaning validation, change implementation, deviation investigations and CAPA implementation among other related duties.

II. GENERAL PROFILE:
  • Manages other leaders of professional technical teams and/or individual contributors
  • Responsible for the performance and results of the department and cross-site alignment
  • Adapts departmental plans and priorities to address resource and operational challenges
  • Decisions are guided by policies, procedures and business plan; receives guidance from manager
  • Provides technical guidance to employees, colleagues or clients 
  • Anticipates and interprets client and/or customer needs to identify solutions
III. BUSINESS EXPERTISE:
  • Applies management skills to align staff activities with department objectives
IV. FUNCTIONAL EXPERTISE: 
  • Work with a cross functional organization consisting of Operations, Technology, Quality, Automation, Global Engineering Services, and Regulatory team members, among others, to develop and maintain manufacturing processes that meet cGMP and business requirements.  
  • Utilize core technology principles to design and develop processes to clean, sterilize, manufacture, formulate, fill, lyophilize, and/or inspect vaccine products.
  • Develop technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstration, process change and/or validation.
  • Assist with troubleshooting and effectively resolving problems. Develop and implement corrective actions to unplanned (atypical) manufacturing events to ensure a consistent and reliable supply and prevent recurrence. 
  • Ability to examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.  
  • Provide leadership on schedule, priorities, and issue resolution to aid the team in accomplishing business objectives.   
  • Coordinate the work of the technical team to identify and implement technology-driven productivity and cost improvements. Exhibit behaviors focused on equipment uptime, minimizing cost and maintaining process consistency.  
  • Assist in authoring regulatory submissions and presenting work to multiple regulatory agencies throughout the inspection process. 
  • Responsible for building/growing the organization’s functional excellence.  Recruit and direct engineers and scientists as necessary.  Develops technical/professional staff through mentoring, assignment selection and training.
V. PROBLEM SOLVING:
  • Directs the resolution of complex technical or business problems
VII. IMPACT:

Influence
  • Explains difficult concepts and persuades others to adopt point of view.
  • Communicates information, asks questions and checks for understanding
Accountability
  •  Accountable for the performance of work group
Decision Making
  • Makes decisions – guided by policies and procedures – that impact the unit’s ability to meet performance objectives
  • Consults on an as-needed basis with next-level manager on more complex decisions and/or issues that impact other units with inter-related processes
VIII. STRATEGIC PLANNING:
  • Adapts and implements departmental plans and priorities based on site and division scorecard to address local business, service and operational challenges 
IX. RESOURCE MANAGEMENT:
  • Forecasts resource needs and manages allocated budget
XII. WORKING RELATIONSHIPS:
  • Reports to Technical Operations Executive Director
  • Manages and interacts with employees within own department
  • Frequent interaction with employees from other departments and sites
  • Interacts with representatives from regulatory agencies
  • Interacts with external suppliers



Qualifications

Education: 
  • Bachelor's Degree or higher in Engineering or Sciences 
Required:
  • Minimum 12 years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations - OR - Master's/PhD Degree plus 10 years experience
  • Minimum four years of Management or Supervisory experience
  • Experience in biologics, vaccine or bulk sterile manufacturing facilities
  • Highly developed communication, leadership and teamwork skills 
  • Experience leading and managing departmental or cross-functional teams
  • Regulatory inspection presentation experience with external regulatory authority representatives. 
Preferred:
  • Master's Degree (or higher) in Engineering or Sciences and/or relevant work experience 
  • Green Belt / Black Belt Certification 

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 an accommodation for the application process please email us at 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:

 

            

            



Job Chemical Engineering

Primary Location NA-US-PA-West Point

Other Locations 

Employee Status Regular

Number Of Openings 1

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