The AutoCAD Engineer will support the Facility and Engineering functions by developing accurate technical drawings, maintaining controlled engineering documentation, and assisting in equipment/facility qualification activities.

AutoCAD Drafting & Facility Design

Prepare, update, and maintain 2D/3D AutoCAD drawings for:

Facility layout (tablet, capsule, cream, nasal spray manufacturing areas)

Equipment layout and installation

Process flow diagrams (PFD) and P&IDs

HVAC, electrical, and utility systems

Cleanroom zoning and material/personnel flow

Develop as-built drawings after modification, relocation, or new equipment commissioning.

Support cross-functional teams in line setup, capacity increase, and layout optimization projects.

Qualification Support (IQ/OQ/PQ)

Assist in the preparation and revision of qualification documents such as:

URS (User Requirement Specification)

DQ/IQ/OQ/PQ protocols and reports

FAT/SAT checklists

Support execution of qualification activities by:

Taking measurements, verifying installation

Collecting evidence (photos, tags, drawings)

Ensuring alignment of qualification documents with engineering drawings

Coordinate with Engineering, QA, and Validation teams to ensure compliance with cGMP and regulatory guidelines.

Engineering Documentation & Control

Maintain controlled records of all engineering drawings and revision histories.

Ensure documentation complies with GMP documentation practices (ALCOA+).

Update and manage technical documents in electronic document control systems (e.g. MasterControl, Veeva).

Review vendor manuals, equipment drawings, and technical data sheets for engineering projects.

Support audits by providing accurate and updated engineering documentation.

Cross-Functional Support

Participate in engineering change control processes (ECR/ECO).

Collaborate with production, maintenance, QA, and validation teams.

Assist in layout planning for:

New product introductions (NPI)

Equipment upgrades or relocation

Cleanroom expansion or modification

Support safety, quality, and compliance initiatives related to facility and equipment design.

Qualifications & Requirements

Diploma or Degree in Mechanical, Electrical, Industrial Engineering, or related discipline.

Proficiency in AutoCAD (2D/3D) is mandatory.

1–5 years of experience in pharmaceutical, biotech, medical device, or regulated manufacturing industries preferred.

Knowledge of:

GMP and regulatory requirements

Cleanroom layouts and flows (personnel/material)

Utilities (HVAC, PW, steam, compressed air)

Equipment used in tablet, capsule, cream, and nasal spray manufacturing

Strong documentation skills and familiarity with qualification documents.

Good communication, teamwork, and attention to detail.

Preferred Skills

Experience with drafting HVAC, P&ID, and utility distribution layouts.

Understanding of qualification protocols (IQ/OQ/PQ).

Exposure to continuous improvement tools (5S, Kaizen, Lean).

Experience with engineering project coordination.