Merck Senior Specialist, Engineering, West Point Technical Operations in West Point, Pennsylvania

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

  • The Senior Specialist, West Point Technical Operations is responsible for providing technical support to one of the vaccine manufacturing areas within Technical Operations. Responsible for implementing continuous improvement projects as well as supporting equipment and investigations as required. Work as an individual contributor, team or project lead.

  • Supports, executes, and/or leads continuous improvement projects that increase compliance, simplify/ standardize and/or gain efficiencies.

  • Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.

  • Provides advanced technical support to manufacturing for complex problems and issues including process/equipment.

  • Designs, conducts, and/or reviews and approves experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.

  • Authors, updates, and/or reviews and approves technical and manufacturing documents necessary for engineering studies, change control.

  • Supports regulatory inspection activities for the facility

  • Provides on-the-floor support of complex operational and technical (process/equipment) issues.

  • • Performs and/or reviews and approves 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.

  • Performs and/or reviews and approves customer complaint investigations aimed to prevent complaint re-occurrence, including determining the root cause, identifying corrective/preventative actions, identifying event scope, and conducting a product impact assessment.

  • Completes and/or leads projects to improve the performance of our processes, including investigation Corrective/Preventative Actions (CAPAs), projects aimed at improving Right-First-Time performance or preventing/reducing deviations, and value capture projects that seek to improve yield/efficiency, reduce cost, or lower our processing cycle times.

  • Supports team safety, environmental, and compliance objectives.

  • Manages project and investigation timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.

  • Collaborates effectively with the area Coaches, Operators/Mechanics, support groups, Quality, Planning, project teams, and external component and equipment vendors.

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 .

Position Qualifications:

Education Minimum Requirement:

B.S. Degree in Engineering or other equivalent technical field

Required Experience and Skills**:

  • Minimum four (4) years’ post-bachelor’s degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance

  • Experience in deviation management and/or change control and/or equipment support and/or project support role.

  • Highly developed communication, leadership and teamwork skills.

  • Ability to manage projects/work to schedule/deadlines.

Preferred Experience and Skills:

  • Change Control author/reviewer

  • Deviation Management investigator/reviewer

  • Customer Complaint investigator/reviewer

  • Experience in biologics, vaccine, or bulk sterile manufacturing facilities

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 at http://www1.eeoc.gov/employers/upload/eeocselfprint_poster.pdf

EEOC GINA Supplement​ at http://www1.eeoc.gov/employers/upload/eeocginasupplement.pdf

SACC, MOJO, LHH-Sanofi-062018

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

Job Engineering Generic

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

Title: Senior Specialist, Engineering, West Point Technical Operations

Primary Location: NA-US-PA-West Point

Requisition ID: ENG003816