Senior CQV Engineer
Cagents
<div> <div> <p>CAI delivers expert commissioning, qualification, validation and consulting services to the global life sciences industry. </p> <p>We are currently looking for experienced Senior CQV Engineers to support major pharmaceutical manufacturing expansion projects across Europe.</p> <h2>Position Summary</h2> <p>The Senior CQV Engineer will support commissioning and qualification activities across manufacturing process equipment, clean utilities, facility systems and supporting infrastructure.</p> <p>The successful candidate will work closely with project engineering, construction, automation, quality and operations teams to deliver compliant systems from installation through qualification and operational readiness.</p> <h2>Responsibilities</h2> <ul> <li>Lead and execute CQV activities for process, utility and facility systems.</li> <li>Author, review and execute commissioning and qualification documentation.</li> <li>Support FATs, SATs, commissioning, startup and qualification activities.</li> <li>Perform field walkdowns and installation verification activities.</li> <li>Review engineering documentation including P&IDs, specifications, drawings and datasheets.</li> <li>Manage deviations, punch list items and commissioning observations through to closure.</li> <li>Participate in risk assessments and quality reviews.</li> <li>Support system turnover and operational readiness activities.</li> <li>Coordinate with vendors, contractors and multidisciplinary project teams.</li> <li>Mentor junior CQV resources where required.</li> </ul> <h2>Requirements</h2> <ul> <li>Degree in Engineering, Science or a related technical discipline.</li> <li>Significant CQV experience within pharmaceutical or biotechnology manufacturing environments.</li> <li>Strong understanding of GMP regulations and qualification practices.</li> <li>Experience supporting large-scale capital projects.</li> <li>Familiarity with Kneat or equivalent electronic validation systems.</li> <li>Experience with FAT/SAT execution and vendor package review.</li> <li>Knowledge of risk-based qualification principles and ASTM E2500 methodologies.</li> <li>Strong troubleshooting, communication and stakeholder management skills.</li> <li> <div>Future opportunities across Ireland, Netherlands, Switzerland and wider European life sciences projects.</div> </li> </ul> </div> </div><p>Find more <a href="https://www.arbeitnow.com/english-speaking-jobs">English Speaking Jobs in Germany</a> on Arbeitnow</a>