Specialist, Engineering -1

Merck•Durham, NC

2d•$87,300 - $137,400•Hybrid

About The Position

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 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. 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, specifically supporting the Inspection part of the process. 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.

Requirements

Bachelor of Science Degree in Chemical Engineering, Biochemical Engineering, Bioengineering, or related life science field with a minimum of two (2) years of relevant experience or a Master of Science Degree.
Experience in vaccine or biologics manufacturing within a cGMP environment
Experience authoring technical documentation (technical investigations, protocols, reports, or change controls) within a cGMP context.
Demonstrated systematic problem-solving skills
Proven leader with influence and outstanding communication (written & presentation) skills
Ability to foster a collaborative work environment
Adaptability
Biodesign
Biological Engineering
Biological Sciences
Change Control Management
Chemical Engineering
Corrective Action Management
Data Analysis
Equipment Troubleshooting
Good Manufacturing Practices (GMP)
Lean Manufacturing
Life Science
Manufacturing
Personal Initiative
Process Optimization
Process Simulation
Professional Integrity
Project Management
Risk Assessments
Risk Control Assessment
Root Cause Analysis (RCA)
SAP Manufacturing Execution (SAP ME)
SAP PP (Production Planning)
Technical Writing

Nice To Haves

Experience with on-the-floor cGMP manufacturing support including providing immediate responses on the shop floor to deviations and supply chain interruptions
Authored process change control
Authored deviation investigations
Experience with validation documentation and execution
Experience with SAP
Experience with Manufacturing Execution Systems (MES)
Experience with Delta V
Ability to read Piping and Instrumentation Diagrams is desired
Lean Six Sigma belt certification
Experience with process risk assessment tools
Experience with responding to regulatory questions with multiple agencies (e.g.FDA, EMA)
Experience with face-to-face presentation of technically complex subjects to regulatory inspectors
Experience with technology transfer methodologies for introduction/launch of a cGMP product

Responsibilities

Authoring and executing validation protocols
Authoring Quality Notifications (QNs)
Providing technical support to manufacturing shop floor for in-process analytics, controls, and troubleshooting
Analyzing complex processing problems through critical analytical thinking and “on the floor” troubleshooting
Development of sound scientific justification for planned material and process / 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
Keeping the supervisor current on the progress of projects, and making improvement recommendations on production procedures
Supporting 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.