MSD-posted 4 days ago
Full-time • Mid Level
Hybrid • Durham, NC
5,001-10,000 employees

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. At the Durham Vaccine Facility in Durham, North Carolina, the Global Vaccine Technology & Engineering (GVTE) Team is seeking candidates to fill IPT Engineering positions to partner with Manufacturing Operations, Quality Operations and Process Automation. GVTE provides technical engineering and manufacturing support for the production of our Company's 24/7 live virus vaccines at Durham. Position Description: We currently have an exciting opportunity for an Engineer to join our vaccine manufacturing Technical Operations department within out Company's Manufacturing Division, supporting a sterile fill, finish, lyophilization vaccine manufacturing facility in Durham, NC. This state of the art facility, started in 2004, is manufacturing our Company's lifesaving vaccines. Due to the importance of this facility in our Company’s Vaccine Manufacturing Supply Chain, the facility has seen rapid growth in production volumes and new employees over the last several years. The IPT (Integrated Process Team) Support Specialist will be part of a cross functional team charged with the technical support of the manufacturing shop floor in a fill-finish vaccine facility. This role requires the ability to execute multiple projects and activities across the IPT. Strategic and effective communication and collaboration skills are essential. The successful candidate will also have robust problem solving skills and a hands-on approach to equipment validation and problem solving, with a bias toward going to see problems for oneself in the field as they arise. Enthusiasm for continuously learning is a requirement.

  • Analyzing complex processing problems through critical analytical thinking and “on the floor” troubleshooting
  • Development of sound scientific justification for planned material and process and equipment changes
  • Working with the Operations, Automation, and Quality functions to determine the breadth and scope of investigations to identify the appropriate root cause, implement corrective actions, complete trending analysis, and determine product disposition
  • Preparing and/or providing guidance and review for regulatory filings, process descriptions, investigations, and change requests.
  • Acts as a participant in domestic and international regulatory agency inspections
  • Supporting all quality and safety initiatives
  • Provide technical support to manufacturing shop floor for in-process analytics, controls, and troubleshooting
  • Keeping the supervisor current on the progress of projects, and making improvement recommendations on production procedures
  • Support on shift support during critical manufacturing runs such as Aseptic Process Simulation, protocol execution, and developmental runs
  • Responsible for authoring process change controls and completing tasks to implement Drug Product equipment/process changes.
  • Serve as a technical writer for Quality Notifications
  • Bachelor degree in an Engineering or Science Related field
  • Minimum two (2) years post-bachelor degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations or military
  • Strategic and effective communication, leadership and teamwork skills
  • Adaptability
  • Adaptability
  • cGMP Guidelines
  • Collaborative Communications
  • Corrective Action Management
  • Electronic Batch Records
  • GMP Compliance
  • Healthcare Innovation
  • Laboratory Experiments
  • Mammalian Cell Culture
  • Multi-Management
  • Personal Initiative
  • Pilot Plant Operations
  • Process Automations
  • Process Engineering
  • Process Optimization
  • Process Simulation
  • Product Formulation
  • Quality Assurance Processes
  • Quality Operations
  • Regulatory Submissions
  • Risk Assessments
  • Risk Control Assessment
  • Standard Operating Procedure (SOP) Writing
  • Sterile Manufacturing
  • Optimizing and troubleshooting aseptic formulation and filling processing operations
  • Familiarity with process risk assessment tools, Quality by Design principles, and Lean/Six Sigma methodologies
  • medical
  • dental
  • vision healthcare and other insurance benefits (for employee and family)
  • retirement benefits, including 401(k)
  • paid holidays
  • vacation
  • compassionate and sick days
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service