QC Equipment Qualification (Medtech)

TL;DR

QC Equipment Qualification (Medtech): Managing the qualification, lifecycle, and decommissioning of QC laboratory equipment within GMP-regulated medical manufacturing environments with an accent on IQ/OQ/PQ processes and compliance. Focus on authoring validation protocols, managing change control, and ensuring data integrity for laboratory systems.

Company

hirify.global is an independent technology consulting firm providing guidance and solutions to businesses across various sectors including Life Sciences and Engineering.

What you will do

• Manage qualification activities for QC laboratory equipment following GMP validation and change control processes.
• Coordinate the full qualification lifecycle, including installation, operational, and performance qualification (IQ/OQ/PQ) and decommissioning.
• Define project strategies, implementation plans, and timelines for qualification projects.
• Author and maintain SOPs, qualification protocols, reports, risk assessments, and training materials.
• Support deviations, investigations, CAPA, and change control activities related to laboratory equipment.
• Collaborate with QC, Validation, Engineering, and QA teams to ensure timely project execution and data integrity.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmaceutical Sciences, or Chemistry.
• Experience with qualification, validation, or lifecycle management in GMP-regulated manufacturing environments.
• Proven ability to author qualification protocols, reports, and SOPs.
• Understanding of change control, deviation, and CAPA processes.
• Strong coordination and stakeholder management skills.

Nice to have

• Familiarity with analytical equipment such as continuous flow analysers, nitrogen analysers, TOC systems, or gas generators.
• Experience with laboratory system integration platforms like LabX.

Culture & Benefits

• Access to an international community with over 110 nationalities.
• Robust internal training system through the Amaris Academy with 250+ available modules.
• Strong commitment to CSR via the WeCare Together program.
• Vibrant workplace with frequent team-building events and afterworks.
• Clear career progression opportunities with a high percentage of leaders promoted internally.

Hiring process

• Brief virtual or phone call to discuss motivations and alignment.
• Average of three interviews with line managers and team members to evaluate experience and skills.
• Potential case study or technical assessment depending on the role requirements.