Position Title: Assembly Specialist (Validation)
Location: Sudair, Saudi Arabia
Department: Finished Production
Reports To: Finished Production Manager
Level: Specialist

Main Purpose:
To support the launch and smooth running of Assembly operations in compliance with regulatory and quality standards.

Key Responsibilities:
Prepare validation/qualification protocols and execute equipment qualifications (FAT, SAT, IQ, OQ, PQ).
Prepare and review GMP documentation including SOPs, CRs, and CAPAs.
Participate in inspections and audits (internal and external).
Comply with SFDA, EU Annex 1, and ISO standards.
Ensure equipment compliance and safety in operations.

Requirements:
Bachelor's degree in Engineering (mandatory).
5+ years of pharma industry experience in equipment qualification and validation.
Strong knowledge of GMP, GDP, ALCOA principles, and regulatory guidelines.
Experience in commissioning/qualification of production/packaging equipment.

Preferred Competencies:
Business-Results Orientation, Leadership, Innovation, and Team Collaboration.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.