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Senior Specialist Job

Employer
Merck
Location
West Point PA
Closing date
Jun 20, 2017

Job Details

Senior Specialist-ENG003255

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. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.


As part of West Point Technical Operations, the LVV Projects Group is seeking a highly motivated individual to support Varicella and MMR vaccine end-to-end projects. The LVV Projects Group is a customer-focused organization designed to lead and provide support for strategic initiatives and site objectives.

The LVV Projects Group provides technical and project management leadership by implementing strategic initiatives across the LVV end-to-end network, thus enabling reliable supply and continued growth. The selected individual will collaborate with cross-functional teams that include Operations, Technical Services, Quality, Automation, Regulatory, Global Technical Operations, Global Vaccine and Biologic Commercialization, MRL, and Supply Chain Management to lead and/or facilitate execution of strategic WP site projects. The individual may be part of a team assigned to execute a large project or will be expected to work independently to manage a series of smaller projects within the LVV E2E portfolio.

Primary Responsibilities:

- Develop and maintain subject matter expertise in technical elements of Varicella, MMR, filling and/or LYO manufacturing processes.

- Build and maintain relationships with LVV E2E IPT technical operations and operations leaders and stakeholders.

- Recognize and advocate for improvement opportunities; implement opportunities within a prioritized portfolio

- Manage projects (scope/resource/schedule development and ongoing maintenance, risk identification and mitigation, appropriate issue escalation and data-driven recommendations and decision) to assure they meet compliance and process requirements.

- Laboratory and/or full scale experiment design and execution or manufacturing data analysis as needed for technical issue resolution.

- Authors and updates technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstration, change control and validation.

- Works as a team member of cross-functional teams to implement strategic projects

- Participates in regulatory inspection activities, as necessary.

Qualifications

Education:

- B.S. Degree in Engineering or Sciences

Required:

- Six (6+) years post-bachelor’s degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 4 years; PhD degree plus 2 years).

- Three (3+) years project leadership and/or management

- Highly developed written and verbal communication, leadership and teamwork skills.

- Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role.

- Experience and understanding of regulations, familiarity with regulatory environment and industry trends for bulk manufacturing and filling processes.

Preferred:

- Advanced degree (M.S., Ph.D.) in science or engineering (Mechanical, Materials or Packaging preferred)

- Change execution management

- Experience in biologics, vaccine, or bulk sterile manufacturing facilities.

- Regulatory inspection presentation experience with external regulatory authority representatives.

- Six Sigma - Black or Green Belt certification

Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our Company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. 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:

EEOC Poster

EEOC GINA Supplement​



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


Job: Engineering Generic

Job Title:Sr. Spclst, Engineering

Primary Location: NA-US-PA-West Point

Employee Status: Regular

Travel: No

Number of Openings: 2

Hazardous Materials: The responsibilities of this position require the employee to enter core sterile manufacturing areas.

Company Trade Name:Merck

Company

Our vision is to make a difference in the lives of people globally through our innovative medicines, vaccines, biologic therapies, consumer health and animal products. We aspire to be the best healthcare company in the world and are dedicated to providing leading innovations and solutions for tomorrow.

We have made it our mission to provide innovative, distinctive products and services that save and improve lives, satisfy customer needs and to be recognized as a great place to work

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