Senior Specialist, Engineering ( MERCUSR114215ENUS)
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.
West Point Technical Services for the Polysaccharide Vaccine End to End is seeking a highly motivated individual to support a capital project technical transfer of a conjugate bulk vaccine manufacturing process to a new facility. In this role, the Senior Specialist will work as an individual contributor in close collaboration with the project team to support qualification of the facility and equipment, assess and implement manufacturing process improvements, and support full scale development and demonstration as the technical expert.
Technical ownership / subject matter expert for portion of the manufacturing process, providing technical support for complex problems and issues including process/equipment.
Managing all timelines (change control, technical documents, sub-projects) to ensure key master project due dates are met; escalating any potential misses and develop remediation plans when possible.
Authoring Change Control documentation for complex process, validation, equipment, facility/utility and/or automation changes.
Authoring technical protocols, applying studies and reporting results/conclusions in support of product tech transfer
Utilize sound engineering principles to support qualified validation processes as required per current Good Manufacturing Practices (cGMPs)
Authoring new or updates to Master Batch Records (production process descriptions) and SOPs (Standard Operating Procedures)
Providing on-the-floor support of operational and technical issues; collaborating with the shop floor to aid in equipment, automation or process trouble shooting or to provide immediate responses to deviations and protocol exceptions
Participating in FAT/SAT, equipment qualification, HAZOP, and Quality Risk Assessment
Promoting team safety, environmental, and compliance objectives.
Collaborating effectively across the project team and PV Focus Factory (Quality, Operations, Mechanical Services, Automation, Outside Contractors, etc.)
Bachelor degree in Chemical Engineering, or Biological Science or other appropriate science or engineering field
Experience and Skills
Minimum of 3-5 years post-Bachelor degree experience in support of Production, Validation, Process Engineering, Technical Operations
Bulk vaccine manufacturing
Leadership and teamwork skills, excellent analytical abilities, established written and verbal communication skills
Ability to work in fast-paced, complex environments and escalate appropriately
Interpersonal, technical aptitude and problem-solving skills
Ability to work both independently and as a part of a Team
Familiarity with cGMPs, CFR, and other appropriate regulations in relation to vaccine manufacturing
Strong technical problem-solving and troubleshooting abilities
Change Control and Project Management
Bulk Vaccine Technical Support
Tackwise, MIDAS, SAP, Delta V
Introduction of process changes to a licensed process
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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