Specialist, West Point Technical Operations, Biological Bacterial Manufacturing (BBM) Projects ( MERCUSR115610ENUS)
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 Specialist, Technical Services Process Engineering in the BioBacterial Manufacturing (BBM) 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 Specialist will work as an individual contributor as well as a team or project lead as required. 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 required based on business unit needs and specific assignments.
Develop and execute Change Control inclusive of change definition, quality risk assessments, impact assessments, task execution, implementation, and support of associated regulatory filings. Lead change requests in order to achieve BBM strategic goals, enable continuous vaccine supply, and provide process robustness
Ensure use of standard project management approaches and assemble, lead, or participate in teams for the execution of projects with responsibility for project planning, deliverables tracking, risk management, and escalation
Operate with some degree of independence, ensuring alignment with appropriate functional leaders and stakeholders while advancing their assigned projects and initiatives
Utilize automated control systems and data trending tools for troubleshooting and process monitoring
Collaborate and engage with multiple functional organizations such as Operations, Technology, Quality, Automation, Global Engineering Services, Procurement, Finance, Above Site Technology, Regulatory, to author CRs, and local procedures as needed, to meet cGMP and business requirements
Author and update technical and manufacturing documents necessary for process design/definition, engineering studies, process demonstrations, and validation
Execute projects in a right first time manner against critical path timelines
Education Minimum Requirement:
B.S. or M.S. in Chemical Engineering, Chemistry, Biology, Biochemistry or comparable discipline
Required Experience and Skills:
Minimum 2 years post-B.S. degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations (or M.S. degree plus 1 years)
Experience in biologics, vaccine, or bulk sterile manufacturing facilities in a maintenance, process or validation support role
Experience with executing projects in a classified, GMP operational production facility
Preferred Experience and Skills:
Strong understanding of Change Control and cGMPs
Experience with bulk and formulation/filling processes
Ability to foster and maintain strong working relationships with technical, quality, and operations leads
Experience with equipment and automation control systems, troubleshooting, and data trending tools (DeltaV)
Experience with SAP and/or submitting BOM/DIR/Master Data changes
Experience with document repositories (e.g. Trackwise, VeevaVault)
Strong analytical, communication and interpersonal skills
Interest and capability in rigorous scientific approaches, operational excellence methods, systems development and change execution management
Ability to design and conduct experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale
Ability to develop and ensures consistent application of standardized work, engineering, and process tools
Regulatory inspection presentation experience with external regulatory authority representatives
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 …
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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Shift:1st - Day
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