GMP Instrument Hook-up Drafter

The Senior GMP Instrument Hook-up Drafter is responsible for leading the creation, review, and coordination of detailed instrumentation hook-up drawings used in regulated environments such as pharmaceutical, biotech, and life science facilities. This role ensures high compliance with GMP, GDP, and validation documentation standards and supports design integration across instrumentation, process, and automation disciplines.

✅ Key Focus Areas:

1. Leadership in Drafting and Design Oversight

   • Lead preparation of complex hook-up drawings for field instruments (pressure, flow, temperature, pH, conductivity, etc.).

   • Supervise and mentor junior and mid-level drafters, ensuring quality and standard adherence.

2. GMP Documentation and Regulatory Compliance

   • Ensure all drawings meet GMP and GDP standards, including traceability, revision control, and validation readiness.

   • Support audits, document reviews, and QA/QC processes.

3. Multi-Disciplinary Collaboration

   • Work with engineering, process design, automation, QA, and construction teams to coordinate installation details.

   • Translate P&IDs, equipment specifications, and loop diagrams into installation-ready hook-up documentation.

4. Advanced CAD Standards and Library Management

   • Define and maintain CAD standards, symbol libraries, and hook-up templates across projects.

   • Drive efficiency in design output while maintaining compliance and documentation clarity.

5. Field and As-Built Coordination

   • Support field validation of design intent through site walk-downs and redlining of as-built drawings.

   • Interface with commissioning teams to ensure drawing packages match installed conditions.

6. Complex Installation Detailing

   • Design hook-ups involving hazardous areas (ATEX, IECEx), sterile utilities (WFI, CIP, SIP), and cleanroom constraints.

   • Specify fittings, supports, impulse lines, and installation hardware suitable for critical environments.

7. Drawing Package Development and Submission

   • Own drawing package lifecycle for projects: from initial design through QA approval, FAT/SAT support, and turnover.

   • Coordinate documentation delivery in alignment with validation protocols and project timelines.

8. Mentorship and Training

   • Guide less experienced team members on GMP design principles, documentation control, and best practices.

   • Participate in training programs and design standard updates.

Qualifications:

• Education:

  • Degree/Diploma in Instrumentation, Mechanical, or Electrical Engineering, or Drafting/Design Technology.

• Experience:

  • Minimum 7+ years of experience drafting instrumentation installations in regulated (GMP) environments.

  • Strong background in pharmaceutical, biotech, or cleanroom-based facility design.

• Technical Skills:

  • Advanced proficiency in AutoCAD and familiarity with 3D model coordination (e.g., Navisworks, Revit MEP).

  • In-depth knowledge of P&IDs, ISA symbols, loop diagrams, and hygienic instrument design practices.