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.
The Specialist, Technical Services Incoming Materials is responsible for providing and occasionally leading technical support to the Incoming Materials team. This individual will work as an individual contributor while actively supporting, participating in, and embracing an empowered team culture. This individual will provide technical guidance, anticipate and interpret client and/or customer needs to identify and implement solutions.
- Executes process improvement projects related to primary packaging components, product contact components and raw materials to assure they meet compliance and process requirements.
- Develops and assures consistent application of standardized work, engineering and process tools.
- Provides technical support to manufacturing for complex problems and issues.
- Designs and conducts experimental protocols as needed in pilot plant or production plant equipment at full scale.
- Authors and updates technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, change control and validation.
- Works as a team member of cross functional teams to complete manufacturing investigations and process improvement.
- Establishes design parameters for primary packaging components subject to change control.
- Participates in regulatory inspection activities for the facility.
This individual will be the technical interface for Incoming Materials with Operations / Quality / Packaging Technologies/ Supplier Development / Regulatory / Procurement groups to enable requirements definition, design and change support of primary packaging components and product contact components. This includes oversight of specifications for components, performance monitoring, investigation support.
- B.S. Degree in Engineering or Sciences
- 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).
- Experience in biologics, vaccine or bulk sterile manufacturing facilities in a process or validation support role with experience in primary packaging components.
- Experience and understanding of regulations, familiarity with regulatory environment and industry trends for primary packaging and product contact components.
- Highly developed communication, leadership and teamwork skills.
- Ability to manage projects to schedule and budget.
- Advanced degree (M.S., Ph.D.) in science or engineering (Mechanical, Materials or Packaging preferred)
- 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 firstname.lastname@example.org.
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Visa sponsorship is not available for this position.
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Merck is an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.
Job: Chemical Engineering
Job Title:Sr. Spclst, Engineering
Primary Location: NA-US-PA-West Point
Employee Status: Regular
Number of Openings: 2
Shift (if applicable): 1st
Company Trade Name:Merck
Nearest Major Market: Philadelphia
Job Segment: Engineer, Law, Procurement, Facilities, Compliance, Engineering, Legal, Operations
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