Senior Specialist, Engineering | Technical Services Process ( MERCUSR115456ENUS)
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.
Key vaccine product franchises are experiencing significant growth requiring staffing to support key initiatives. The Senior Specialist, Technical Services Process Engineering in the Manufacturing End-to-End is responsible for technical leadership and execution of projects in the commercial manufacturing area while actively supporting, participating in, and embracing an empowered team culture.
In this role, the Sr Specialist will work as an individual contributor as well as a team or project guide to direct the work of others. Additionally, this role will contribute to the performance and results of a department, provide technical guidance, and anticipate and interpret client and/or customer needs to identify and implement solutions. Limited off-shift or weekend coverage may be suggested based on business unit needs and specific assignments.
Accountable for defining and directing projects
Use standard project management approaches, assemble and direct teams in the execution of projects with duties for resourcing, charter development, project planning and tracking, risk management, and escalation
Operate with a high level of self-direction, assuring alignment with appropriate functional stakeholders while advancing their assigned projects and initiatives
Interest and capability in rigorous scientific approaches, operational excellence methods, systems development and change execution management, and strong systematic, communication, and interactive skills
Partners and engages with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, among others, to develop and maintain processes that meet cGMP and business regulations
Establish project resource guidelines and works with stakeholders to gain the sponsorship needed from subject matter experts
Develop and implement change control complete with change definition, risk assessments, impact assessments, task execution, implementation, and all-encompassing of associated regulatory filings
Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation
Design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale; Provide technical assistance to manufacturing for complex problems and issues
Examine an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best comprehend and resolve the root cause
Develop and assures consistent application of standardized work, engineering, and process tools
Problem-solving skills and a hands-on approach to problem-solving, with a bias toward going to see problems for oneself in the field
Technical reviewer/approver for process changes
Process improvement projects, complex manufacturing investigations, digital and data integrity initiatives for the project
Regulatory inspections-based requests
Bachelor degree in Engineering or Science
Experience and Skills
Minimum four years post-bachelor degree in GMP manufacturing and/or technical guidance of GMP manufacturing operations (or M.S. degree plus three years; Ph.D. degree plus one year)
Skills and working knowledge in biologics, vaccine, or bulk sterile manufacturing facilities in maintenance, process, or validation promotion role
Minimum of three years project management with project implementation in qualified production facilities
Strong comprehension of Change Control | Minimum two years work and skill development in Change Control
Advanced education (M.S., Ph.D.) in science or engineering
Ability to maintain strong working relationships with technical, quality, and operations directors
Equipment and automation troubleshooting
Process monitoring and trending tools
DeltaV, GCM experience
Regulatory inspection presentation experience with external regulatory authority representatives
Fermentation | Purification | Validation | Formulation and filling processes
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
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.
Invent. Impact. Inspire.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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Number of Openings:1