Key Skills

Job Description

WE ARE HIRING | Senior CQV Engineer – KNEAT | Clean Utilities & HVAC Central Europe Pharmaceutical / Life Sciences 12-Month Consulting Project Start: ASAP 4.Operations is recruiting an experienced Senior CQV Engineer / Process Engineer to support a major pharmaceutical engineering project in Central Europe. We are specifically looking for candidates combining hands-on KNEAT experience with strong pharmaceutical CQV expertise. KNEAT EXPERIENCE IS MANDATORY Candidates must have practical experience using KNEAT within CQV / validation activities. CLEAN UTILITIES – PQ • Develop and execute PQ strategies • Author, review and execute PQ protocols, execution sheets and reports • Work with KNEAT for CQV / validation documentation and execution • Support qualification of PW, WFI and Clean Steam systems • Develop sampling strategies with QC and Engineering • Assess readiness for sampling and PQ phase progression • Conduct system walkdowns and resolve technical/documentation gaps • Coordinate with C&Q, QC, Engineering, Operations and vendors • Support SOPs, maintenance planning, spare parts and operational handover HVAC – C&Q • Support pharmaceutical HVAC C&Q activities • Review P&IDs and Traceability Matrices • Review and execute IV/OV test scripts • Manage CQV documentation through KNEAT • Support Installation Verification and Operational Verification • Participate in field walkdowns, testing and system startup • Resolve technical discrepancies and outstanding vendor documentation • Support Operational Readiness and final handover ESSENTIAL REQUIREMENTS ✓ Hands-on KNEAT experience – MANDATORY ✓ Pharmaceutical / biotechnology CQV experience ✓ Strong IQ/OQ/PQ and/or IV/OV knowledge ✓ Experience authoring, reviewing and executing qualification documentation ✓ Experience within GMP-regulated environments ✓ Clean Utilities and/or HVAC qualification experience ✓ Strong English communication skills ✓ Able to work on-site in Central Europe HIGHLY DESIRABLE ✓ Clean Utilities expertise – PW / WFI / Clean Steam ✓ HVAC C&Q experience ✓ PQ sampling strategy experience ✓ P&IDs and Traceability Matrix experience ✓ Operational Readiness / SOP / maintenance handover experience ✓ German – basic/conversational level through to professional fluency is highly advantageous CONTRACT Expected duration: 12 months Start: ASAP Central Europe Strong on-site presence required; some hybrid flexibility may be considered Consulting / Project Assignment INTERESTED? Please send your latest CV together with: • Details of your KNEAT experience – projects, duration and how you used the platform • Availability / notice period • Current location and mobility for Central Europe • German level: Basic / Conversational / Professional / Fluent • Expected all-inclusive daily rate [email protected] Subject: Senior CQV – KNEAT 4.Operations | Connecting specialist professionals with major European Engineering & Life Sciences projects.

Core Responsibilities

Develop and execute qualification activities for clean utilities, including PW, WFI, and clean steam, and support pharmaceutical HVAC commissioning and qualification. Manage CQV documentation and test execution in KNEAT, resolve technical and documentation gaps, and support operational readiness and system handover.

Requirements

Candidates must have hands-on KNEAT experience and pharmaceutical or biotechnology CQV experience in a GMP-regulated environment, with strong qualification documentation and IQ/OQ/PQ or IV/OV knowledge. Clean utilities and/or HVAC qualification experience, strong English, and the ability to work on-site in Central Europe are required; German and related handover experience are advantageous.