Job Description

The Specialist is responsible for technical support and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture. In this role, you will work as an individual contributor, may act as a team or project lead, and lead others as required, as well as contribute to the performance and results of a department. Additionally, you will provide technical guidance and anticipate and interpret needs to identify and implement solutions. Qualifications: Education: Bachelor's Degree in Engineering or Science related field. Required Experience and Skills: · Minimum of two (2) years of work experience in the biological/ pharmaceutical/chemical manufacturing industry. · Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a process or validation support role. · Six (6) months' work experience with cGMPs, Change Control, CFR, and other appropriate regulations for vaccine manufacturing. · Experience w/Microsoft Office suite, and process tools (i.e. TrackWise, IPI, MS Project, Excel). Preferred Experience and Skills: · Strong understanding of Change Control and Project management · Ability to work both independently and as a part of a team. · Strong technical problem-solving abilities. · Demonstrated effective written and verbal communication skills. · Familiarity or experience with aseptic Vaccine Manufacturing Operations or Equipment. · Experience with the introduction of process changes to a licensed process. Additional responsibilities include: · Establish and manage project schedules and timelines · Determine project resource requirements and works with stakeholders to gain the support needed from subject matter experts. · Stakeholders may include Operations, Quality, Regulatory, Analytical, and Process Development functions. · Responsible for stakeholder engagement, communication, and risk escalation. · Develop and execute a change control inclusive of change definition, risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings. · Author/ update technical and manufacturing documents necessary for process design/ definition, engineering studies, process demonstrations, and validation. · Design/conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale. Company Description Merck Sharp & Dohme Corp. ("Merck") is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures, and markets a broad range of innovative products to improve human health, directly and through its joint ventures Imagine getting up in the morning for a job as important as saving and improving lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery or scientific genius to work in collaboration with other like-minded colleagues to pursue and bring hope to countless people who are battling the most challenging diseases of our time. Our team is always evolving, so if you are among the intellectually curious, join us--and start making your impact today.

Company Description

Merck Sharp & Dohme Corp. ("Merck") is a leading research-driven pharmaceutical products and services company. Merck discovers, develops, manufactures, and markets a broad range of innovative products to improve human health, directly and through its joint ventures\r\n\r\nImagine getting up in the morning for a job as important as saving and improving lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery or scientific genius to work in collaboration with other like-minded colleagues to pursue and bring hope to countless people who are battling the most challenging diseases of our time. Our team is always evolving, so if you are among the intellectually curious, join us—and start making your impact today.