CQV Engineer

Overview

Mantell Associates is partnered with a global Consulting firm exclusively focused on the Life Sciences and Healthcare sector, who is seeking a fluent German-speaking CQV Engineer to support a critical project in Berlin.

This role will focus on water systems inspection and cleaning validation in a regulated GMP environment and offers the chance to contribute to compliance excellence at the heart of pharmaceutical manufacturing.

CQV Engineer - Responsibilities:

• Perform and oversee water systems inspections, ensuring compliance with regulatory and GMP requirements
• Develop, write, and execute cleaning validation protocols (including CIPs, FAT/SAT, IQ/OQ/PQ documentation) for manufacturing equipment and utilities
• Partner with cross-functional stakeholders across Engineering, Validation, and Quality to deliver project milestones on time and to the highest quality standards
• Ensure all activities are aligned with internal quality frameworks and global regulatory expectations (EU GMP, PIC/S, GAMP5)
• Prepare clear validation documentation, manage deviations, and support CAPA processes where required

CQV Engineer - Requirements:

• Strong experience in water system qualification and cleaning validation within pharma or biotech manufacturing
• Practical knowledge of protocol development, qualification execution, and cleaning lifecycle management
• Fluent in German (spoken and written), with excellent technical documentation skills
• Solid understanding of GMP standards and validation practices across production systems and utilities
• Based in or near Berlin with the ability to work on-site 2–3 days per week (hybrid model)
• Available to start within the next month and able to commit to a 40-hour work week for a 6-12 month engagement

About Mantell Associates:

Mantell Associates is a specialist Pharmaceutical and Life Science headhunting firm. For more information on this opportunity, contact us at +44 (0)20 3854 7700.