Merck Senior Specialist, Global Engineering Solutions in Durham, North Carolina
Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.
The Senior Specialist in Global Engineering Solutions will operate under the guidance of a Technology Director or Associate Director supporting the growing portfolio of capital work in the Large Molecule Line of Business. The Senior Specialist will participate in a high performing team and be responsible for implementation of capital project scope using the Capital Management stage gate process to support our business objectives. The Senior Specialist will demonstrate increasing degrees of responsibility to lead project deliverables ranging from business case development, process design/specification/vendor management, through commissioning and qualification, process implementation and realization.
The Senior Specialist will exhibit sound leadership and exemplary collaboration, communication and vendor management skills; and is expected to develop and maintain advanced technical knowledge in their respective area(s) of expertise. The Senior Specialist will have opportunities to support the wider portfolio of Biologics, Vaccines and Sterile needs, as well as to be exposed to multiple business areas. Flexibility with travel in excess of 50% and work location is required.
Project Size is anticipated to be >$50 MM. The position will require technical oversight to junior engineers and resources from an engineering firm.
Leads or supports process design efforts for capital projects, providing innovative solutions that meet business objectives.
Collaborates with a team in the evaluation of alternative solutions and the development of project scope;
Leads aspects of preliminary designs, including P&ID development and HAZOP facilitation;
Ensures that deliverables conform to our standards and practices, and are technically sound
Provides technical guidance during project implementation, including C&Q, to assure viability of technology in proposed configuration;
Liaises with other technical functions to ensure successful technology implementation for transfer of new and in-line products;
Collaborates with contractors, suppliers and other team members in the execution of the work.
Percent of travel: >50% for projects assignments outside of primary location. Travel and flexibility in project assignment location is required; assignments may require short term travel assignments.
Education Minimum Requirement:
- B.S. in Engineering (i.e. Chemical, Mechanical) or Applicable Science
Required Experience and Skills:
Experience in Pharmaceutical/Biotech industry in engineering or manufacturing of vaccines or biologics – solid base in engineering fundamentals and equipment troubleshooting.
Experience with an equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting and qualification
Understanding of hygienic design and unit operations specific to vaccine/biologic manufacturing and aseptic processing
Strong awareness of Quality Guidance and industry Regulations.
Excellent collaboration and engagement as a team player with strong interpersonal and communication skills
Analytical and Problem Solving Skills – demonstrated ability to apply creative, innovative, “out of the box” thinking to solutioning.
Project/Time Management skills which deliver on time and quality work.
Ability to travel, both domestic and international.
Preferred Experience and Skills :
Experience with capital projects that followed a stage gate capital management process
8+ years experience in engineering or operations with 5+ years experience related to vaccines or biologics
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that’s committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world’s biggest investors in Research & Development.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth .
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Requisition ID: R21495
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