Senior Specialist, Engineering
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.
At Merck's campus in Elkton, Virginia, we currently have a Senior Specialist, Engineering position available within the Technical Services team. The manufacturing facility is located in the Shenandoah Valley along the Shenandoah River and the Blue Ridge Mountains - just a short distance from the University of Virginia and James Madison University.
The successful candidate will have the opportunity to apply their enthusiasm and technical skills as a member of a multidisciplinary team supporting the operation of pharmaceutical/biopharmaceutical/vaccine product manufacturing facilities.
Assignments and duties will include:
•Realization of a new, state-of-the-art bulk sterile antibiotic facility to include:
Sterile Challenge Execution Support
Operational Readiness Activities
SOP / Batch Record and Documentation Prep
Engineering Lot Execution / PPQ Readiness / PPQ Execution
Change Control Support
•achieve Safety, Quality, and Environmental compliance excellence in all assignments
•leading and conducting technical investigations and analyses, recommending corrective actions, and seeing them through to successful, sustainable implementation
•writing, reviewing, improving documentation for technical and regulatory compliance excellence
•contributing to process and equipment safety reviews
•teaching, coaching, mentoring, and learning from team members
•B.S. degree in chemical engineering, biochemical engineering, biological systems engineering, industrial engineering, mechanical engineering, biology, biochemistry, chemistry or related science or engineering discipline and a minimum of six years of relevant industrial experience
The successful candidate must have:
•GMP Manufacturing Experience
•Demonstrated project management capabilities and change control experience.
•Strong problem solving skills and a hands-on approach to problem solving, with a bias toward going to see problems for oneself in the field.
•Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills are required.
•The ability to examine an issue from diverse perspectives (safety, compliance, maintenance, automation, equipment, process, and people) in order to best understand and resolve it.
•Enthusiasm, confidence and initiative-taking ability needed for continuous learning and its applications.
•Facility start-up expertise
•Antibiotic manufacturing experience
•Emerson DeltaV DCS experience
•Merck change control experience/expertise
•Biologics or vaccine processing experience
•Sterile processing experience
•CMC / regulatory submission experience
If you are the kind of individual who thrives on challenge and possess the technical, leadership and business, and communication skills that are of value to our business, we invite you to apply. Consistently cited as a great place to work, we discover, develop, manufacture and market a wide range of vaccines and medicines to address unmet medical needs. Each of our employees is joined by an extraordinary sense of purpose - bringing Merck's finest achievements to people around the world.
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 email@example.com.
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Visa sponsorship is not available for this position.
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