Senior CQV Engineer

<p>We are urgently seeking senior-level CQV Subject Matter Experts (SMEs) to assist in developing User Requirement Specifications (URS) and conducting risk assessments for process-equipment projects. The ideal candidates will bring extensive experience in CQV activities, particularly in brownfield settings, and will have a hands‑on understanding of complex process equipment. </p> <h3>Key Responsibilities </h3> <ul> <li>Lead and support the development of User Requirement Specifications (URS) for process equipment. </li> <li>Facilitate and participate in risk assessments ensuring comprehensive analysis and mitigation planning. </li> <li>Provide technical expertise and guidance to project teams throughout CQV activities. </li> <li>Collaborate closely with stakeholders, including engineering, quality, and operations teams. </li> </ul> <h3>Qualifications </h3> <ul> <li>Minimum of 10 years of direct CQV experience on process-equipment projects, preferably in brownfield environments. </li> <li>Deep knowledge of reactors, centrifuges, filters/filter dryers, dryers, storage tanks, and containment solutions is a strong advantage. </li> <li>Senior professionals with biopharma backgrounds and proven experience in CQV execution and complex process equipment are highly valued. </li> <li>Familiarity with digital CQV platforms, specifically Kneat, is a significant plus. </li> <li>Excellent communication skills and ability to work collaboratively in multidisciplinary teams. </li> </ul> <h3>Preferred Skills </h3> <ul> <li>Hands‑on experience with process equipment in pharmaceutical or biopharma environments. </li> <li>Demonstrated expertise with containment solutions and advanced CQV methodologies. </li> <li>Proven track record of success in senior-level CQV project roles. </li> </ul> #J-18808-Ljbffr