The Mid-Level GMP Instrument Hook-up Drafter is responsible for developing, updating, and maintaining instrument hook-up drawings for installation in GMP-compliant environments. This role requires a solid understanding of instrumentation, clean utility systems, and regulatory documentation practices. The drafter collaborates closely with engineers and field teams to ensure accurate representation of installation details, ensuring compliance with pharmaceutical/biotech standards.
Advanced Hook-Up Drafting
Create and modify detailed instrument hook-up drawings for transmitters, indicators, control valves, and analytical devices.
Specify tubing, fittings, supports, instrument connections, and process interfaces based on project specifications.
GMP-Compliant Documentation
Ensure drawings are developed and maintained in line with GMP, GDP, and validation requirements.
Integrate revision control, redlining, document numbering, and QA release procedures.
Engineering Collaboration
Work with instrumentation and process engineers to understand installation requirements and process conditions.
Interpret P&IDs, instrument data sheets, and loop diagrams to generate accurate hook-up layouts.
CAD Proficiency and Standardization
Use AutoCAD (or equivalent) to draft 2D layouts based on standard project templates.
Maintain and update block libraries, layering conventions, and drawing standards per client and internal QA protocols.
Design Accuracy and Field Integration
Ensure accuracy of dimensional data, mounting orientations, process connections, and material compatibility.
Support design coordination with construction and commissioning teams to reflect field conditions.
Project Documentation and Package Support
Contribute to drawing packages for FAT, SAT, and commissioning, ensuring traceability and completeness.
Prepare drawing registers, BOMs, and hook-up legends as part of documentation deliverables.
Regulatory and Safety Focus
Incorporate cleanroom installation requirements, material traceability, and ergonomic access in designs.
Reflect pressure ratings, hygienic fittings, and sterile utility connection standards in hook-up details.
Mentorship and Peer Review
Review junior drafters’ work for compliance and completeness.
Provide guidance on clean design principles, GMP documentation, and project workflows.
Education:
Diploma or Degree in Instrumentation, Mechanical, Electrical Engineering, or Drafting Technology.
Experience:
3–6 years of relevant experience in drafting for GMP, pharmaceutical, biotech, or cleanroom environments.
Technical Skills:
Proficient in AutoCAD or similar 2D drafting platforms.
Understanding of instrumentation types (flow, pressure, pH, conductivity) and installation best practices.
Familiar with P&IDs, loop diagrams, and GMP documentation systems.