Associate Specialist, Process and Instrumentation Engineer

Merck Merck · Pharma · NE

The Associate Specialist, Process and Instrumentation Engineer role at Merck focuses on developing and maintaining engineering, automation, and calibration teams to ensure high levels of process support and maintainability. This role involves defining key operating parameters, managing the calibration system, documenting processes, and investigating deviations. It requires close collaboration with various departments and supports biological processes for vaccine production. The position emphasizes process definition, critical parameter hierarchy, and regulatory compliance within a regulated environment.

What you'd actually do

  1. Develop and maintain the Engineering, Maintenance, Automation, and Calibration teams in high levels of process support and maintainability.
  2. Serve as a Calibration System Administrator, responsible for defining, documenting, qualifying, and communicating the calibration details of process and utility instrumentation.
  3. Play a critical role in defining new processes, change management, deviation investigation, process improvement, and efficiency improvement.
  4. Work closely with Project Managers, Maintenance Personnel, Calibration Personnel, Automation Engineers, Quality Assurance, Process Development, Production Management, and multiple levels of management.
  5. Support Biological processes supporting vaccine production including: Fermentation, Concentration, Clarification, Blending, Sterile Filling, Freeze Drying, Serialization, and Packaging.

Skills

Required

  • Bachelor of Science in Engineering degree
  • 0-3 years of relevant industry work experience
  • Adaptability
  • Biopharmaceutical Operations
  • CAD Proficiency
  • Data Analysis
  • Engineering Principle
  • Engineering Standards
  • Estimation and Planning
  • Experimentation
  • Instrumentation
  • Instrumentation Engineering
  • Process Optimization
  • Professional Engineering
  • Project Management
  • Software Proficiency
  • System Control
  • Teamwork
  • Technical Communication
  • Technical Problem-Solving

Nice to have

  • Process Engineer
  • Commissioning & Qualification Engineer
  • Quality Assurance Specialist
  • Automation Engineer
  • Instrument Engineer
  • Calibration Administrator

What the JD emphasized

  • process support
  • maintainability
  • Calibration System Administrator
  • defining new processes
  • change management
  • deviation investigation
  • process improvement
  • efficiency improvement
  • process drawings
  • electrical drawings
  • piping diagrams
  • automation design documents
  • construction specifications
  • SOPs
  • Process documentation
  • instrumentation specifications
  • Biological processes
  • vaccine production
  • Fermentation
  • Concentration
  • Clarification
  • Blending
  • Sterile Filling
  • Freeze Drying
  • Serialization
  • Packaging
  • change controls
  • deviations
  • root cause analysis
  • corrective and preventive action