Amber Project is a purpose driven company focusing on helping Expats and Senior IT profiles to the right job by our network of workplaces.

We only work with passionate partners who want to help and evolve existing talents to succeed with the right coaching and support in our AMBERPROJECT ACADEMY.

Our network consists of a wide range of municipal partners as well as professional IT organizations with a mutual commitment to help competent professionals back to IT organizations.

On behalf of our Amber Workplaces are we currently searching for a skilled CQV Consultant

We are looking for an experienced CQV consultant to lead commissioning, qualification, and validation (CQV) activities in pharmaceutical and biotechnology projects. This role requires hands-on field experience and strong documentation and regulatory compliance skills.

Key Responsibilities

• Perform IQ, OQ, and PQ on process equipment, utilities, and automation systems.
• Conduct P&ID walkdowns, loop checks, and instrument calibrations.
• Review and prepare CQV documentation, including validation protocols and risk assessments.
• Ensure compliance with GMP, FDA, EMA, and GEP.
• Manage deviations, CAPA processes, and validation documentation approvals.
• Plan and execute FAT and SAT with clients and suppliers.

Requirements

• Degree in engineering, chemistry, biotechnology, or related field.
• 3-5 years of CQV experience in GMP-regulated environments.
• Expertise in IQ, OQ, PQ, risk assessments (FMEA, HAZOP), and troubleshooting.
• Strong understanding of SCADA, PLC, and automation qualification.
• Excellent communication and collaboration skills.

Preferred Qualifications

• Experience with sterile production, HVAC, water treatment, and purified gases.
• PMP, PRINCE2, or CQV-specific certifications.
• Expertise in FAT/SAT processes and supplier management.
• Knowledge of biotechnological/aseptic production and data integrity standards.