Senior CQV Engineer
Katalyst Healthcares and Life Sciences
Job Description:
We are seeking an experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical, biotechnology, or life sciences manufacturing facilities. The role will support equipment, utilities, facilities, and manufacturing systems while ensuring compliance with GMP, FDA, GxP, and applicable industry standards.
Responsibilities:
We are seeking an experienced Senior CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities for pharmaceutical, biotechnology, or life sciences manufacturing facilities. The role will support equipment, utilities, facilities, and manufacturing systems while ensuring compliance with GMP, FDA, GxP, and applicable industry standards.
Responsibilities:
- Lead Commissioning, Qualification & Validation (CQV) activities for manufacturing equipment, utilities, facilities, and systems.
- Develop and execute URS, DQ, FAT, SAT, IQ, OQ, and PQ documentation and protocols.
- Develop CQV plans, validation strategies, protocols, reports, and traceability documentation.
- Review engineering specifications, P&IDs, drawings, equipment documentation, and vendor packages.
- Coordinate and execute FAT/SAT activities with vendors, Engineering, Quality, and project teams.
- Perform equipment and utility qualification activities in accordance with approved procedures.
- Develop and execute risk assessments, including FMEA and criticality assessments.
- Ensure validation activities are aligned with GMP/GxP, FDA, EU GMP, GAMP 5, and ISPE requirements.
- Support commissioning activities and transition systems from construction through qualification and operational readiness.
- Manage deviations, discrepancies, change controls, and CAPA associated with CQV activities.
- Perform root cause analysis and implement appropriate corrective and preventive actions.
- Review and approve test results, qualification packages, and validation reports.
- Coordinate with Engineering, Automation, Manufacturing, Quality Assurance, Facilities, and external vendors.
- Provide technical leadership and mentoring to junior CQV engineers.
- Support project schedules, resource planning, and CQV deliverables.
- Bachelor's degree in mechanical, Electrical, Chemical, Biomedical, Pharmaceutical, or related Engineering discipline.
- Typically, 7-10+ years of CQV/validation experience in pharmaceutical, biotech, medical device, or other regulated industries.
- Strong knowledge of GMP/GxP validation requirements.
- Excellent technical writing, communication, leadership, and problem-solving skills.
Vacancy posted 5 days ago
Similar jobs that could be interesting for youBased on the Senior CQV Engineer in Montpelier, VT vacancy
$68.3k - $148.3k
...Job Description The Senior Systems Engineer will play a vital role in managing and optimizing Linux-centered systems for Oracle Health CWx US Public Client Ops. This role involves overseeing cloud and on-premise infrastructure, implementing security measures, and ensuring...SeniorTemporary workFlexible hoursOracle
Montpelier, VT4 days ago$71.2k - $166.1k
...human, you’ve come to the right place. About this position: Oracle Health Government Services is seeking a skilled Federal Senior Engineer/Architect (Principal Consultant) to join our mission-driven organization. In this role, you will be responsible for leading...SeniorTemporary workFlexible hoursOracle
Montpelier, VT2 days ago- ...If you love high profile and challenging programs and Marine Engineering projects supporting the U.S. Navy and commercial customers - Serco... .... Serco is looking for an experienced and enthusiastic Senior Electrical Engineer to join our dynamic Maritime Engineering Operation...SeniorFull timeContract workPart timeFor contractorsLocal areaFlexible hours
Serco
Montpelier, VT4 days ago $168k - $200k
...that is passionate about creating transformative change in healthcare. What We're Looking For We're looking for a Senior Site Reliability Engineer to join our Data & ML Platform team. You'll be at the forefront of building and operating a resilient, observable,...SeniorRemote workDatavant
Montpelier, VT1 day ago$121.4k - $218.6k
...systems that scale? Join our highly skilled Site Reliability Engineering team! Our team designs, develops, and manages applications... ...efficiency through automation and resource optimization. As a Senior Site Reliability Engineer, you will be responsible for:...SeniorWork experience placementWork at officeAkamai
Montpelier, VT5 days ago$81.1k - $187k
...Job Description We are looking for a Site Reliability Engineer 3 to support mission-critical cloud services and production operations. The role focuses on improving service reliability, reducing operational risk, automating repetitive tasks, and driving faster detection...SeniorTemporary workImmediate startFlexible hoursShift workOracle
Montpelier, VT1 day ago$120k
...Verdantas, we're redefining environmental consulting and sustainable engineering through our use of cutting-edge modeling and digital... ...the future of resilient communities? Verdantas is seeking a Senior Water/Wastewater Engineer to join any of our New Hampshire,...SeniorFull timeContract workTemporary workLocal areaRemote workFlexible hoursVerdantas
Montpelier, VT3 days ago$126.2k - $264.1k
...planning, and post-event reviews to strengthen reliability and execution discipline. Partner closely with Facility Managers, Engineering, Reliability, Controls, Construction, and Commissioning teams to ensure effective handoffs, operational readiness, and maintainability...SeniorTemporary workFor contractorsRelocationRelocation packageFlexible hoursOracle
Montpelier, VT1 day ago- ...solution validation phases through product go-live. The Project Engineer (PE) must have well rounded knowledge in all areas of medical... ...experience in a hospital, Cardiology or Radiology setting in an senior technical or managerial role. Special Skills or Other Job...SeniorFull timeLocal areaRemote workFlexible hours
FUJIFILM Corporation
Montpelier, VT1 day ago - ...environment. The candidate will serve as mentor for staff, provide senior technical support for a variety of projects at hazardous waste... ...will involve a variety of analysis and design; preparation of engineering design calculations, drawings, and specifications; technical...SeniorContract work
- ...Job Description \n \n \n POSITION SUMMARY:\n \n \n \n \n \n \n \n \n \n \n The Certified Staff 1 and 2/Senior Sonographer works under the administrative direction of the Radiology Director and Operations Supervisor, and under the clinical direction and guidance of...Senior
University of Vermont Health - Central Vermont Medical Cente...
Berlin, VT4 days ago $169.3k - $304.7k
...organizational standards and tooling to ensure the growth and stability of our global platform. As a Principal Site Reliability Engineer - Network, you will be responsible for: Architecting, building and supporting solutions that foster efficient and streamlined...Work experience placementWork at officeAkamai
Montpelier, VT2 days ago$84.9k - $209.5k
...care. Oracle Health is seeking a Principal Site Reliability Engineer to strengthen the reliability, performance, security, and scalability... ...trends, sharing valuable insights and information with senior team members, management, and beyond to promote innovative building...Temporary workImmediate startFlexible hoursShift workOracle
Montpelier, VT1 day ago$114.6k - $234.6k
...reliability assessments, resolves defects, and integrates new materials to improve hardware products. Manages mechanical design aspects of engineering projects, ensuring alignment with project timelines, quality standards, and design goals. ? Responsibilities...Temporary workFlexible hoursShift workOracle
Montpelier, VT5 days ago$114.6k - $234.6k
...Job Description We are seeking a skilled engineer or scientist to lead the deployment and management of direct-to-chip liquid cooling technology with our external manufacturing partners. The successful candidate will ensure robust technical implementation, drive quality...Temporary workFlexible hoursOracle
Montpelier, VT4 days ago- POSITION SUMMARY At the administrative direction of the Director / Operations Supervisor, and the clinical direction of the Radiologist / Team Leader independently performs the majority of exams with minimal supervision. Assumes responsibility for designated areas or...
University of Vermont Health - Central Vermont Medical Cente...
Berlin, VT2 hours ago $169.8k - $355.4k
...problems with our assistance and expertise. In this role, you will have an opportunity to work with teams of applied scientists and engineers to deliver high quality computer vision models and services that delights our customers with the confidence that their data are...SeniorTemporary workFlexible hoursOracle
Montpelier, VT3 days ago- ...Job Description Job Description Senior Electrical Engineer NOMAD mobilizes battery storage so power can move with the mission—utilities, data centers, disaster response, and off-grid sites that cannot wait for a substation. As Senior Electrical Engineer you own the...Senior
- ...strengthens the team's core technical capabilities through mentoring, training, coaching, and knowledge sharing. Leads by example as a senior member of the team, providing technical guidance, promoting best practices, and fostering a culture of continuous learning and...Senior
$102.3k - $209.5k
...assessments to evaluate suitability for data center builds. Acts as the engineering representative on a wide range of moderately complex on-site... ...Design, Leadership, and Governance: -Collaborates with senior team members and supports a project or other design and...Contract workTemporary workFor contractorsFlexible hoursShift workOracle
Montpelier, VT5 days ago- ...The Certified Staff 1 and 2/Senior Sonographer at University of Vermont Health - Central Vermont Medical Center operates under Radiology leadership to perform routine, complex and highly technical ultrasound procedures for diagnosis. The role requires RDMS/RVT credentials...Senior
University of Vermont Health - Central Vermont Medical Cente...
Montpelier, VT3 days ago $114.6k - $234.6k
Job Description The ideal candidate has strong power-systems engineering experience, particularly in utility interconnection, substations, energy storage, on-site generation, and large-load infrastructure. Key Responsibilities Power Systems Engineering Develop and assess...Temporary workFlexible hours$140k - $185k
...GenAI delivery team and the higher education and SLED (state, local, and education) institutions it serves. The Forward Deployed Engineer works directly with client technical stakeholders to scope solutions built on the Gemini Enterprise Agent Platform (Google’s 2026...Full timeContract workTemporary workWork at officeLocal areaRemote workNelnet
Montpelier, VT2 days ago$126.2k - $264.1k
...Job Description We are seeking a highly experienced Senior Principal Technical Program Manager (TPM) to lead complex customer engagements... ...of customer requirements, manufacturing operations, engineering, and business execution. The ideal candidate possesses deep...SeniorContract workTemporary workFlexible hoursOracle
Montpelier, VT4 days ago$100.32k
...PTO accrual beginning Day 1 Note: Benefits may vary based upon position type and/or level. Job Summary The Software Developer, Senior develops high-level applications for the System. This includes design, implementation, and testing of applications. Provides advanced...SeniorWork experience placementImmediate start$110k - $140k
Senior Software Engineer Location: United States (Remote) The Role The Senior Software Engineer is a senior individual contributor responsible for designing, developing, and delivering high-quality, scalable, secure, and reliable software solutions that support Pearson...SeniorFull timeRemote work- ...Job Description POSITION SUMMARY: The Certified Staff 1 and 2/Senior Sonographer works under the administrative direction of the Radiology Director and Operations Supervisor, and under the clinical direction and guidance of the Radiologist and Ultrasound Team Leader...Senior
University of Vermont Health - Central Vermont Medical Cente...
Berlin, VT14 hours ago - POSITION SUMMARY At the administrative direction of the Director/Operations Supervisor/ Team Lead, and the clinical direction of the Radiologist, perform diagnostic studies utilizing radiopharmaceuticals and imaging equipment with minimum supervision. Assay and administer...
The University of Vermont Health Network
Montpelier, VT4 days ago $260.1k
...together quarterly for intense in-person working sessions called “surges.”learn more about working at Coinbase. As a Senior Staff Software Engineer on thePlatform Payments team, you'll define the engineering vision for how fiat moves into and out of Coinbase across 5...SeniorLocal area$121.4k - $218.6k
...solutions for government networks? Join Our Custom Government Engineering Team! The Custom Government team operates across the full... ...seeking an experienced, self-motivated, and highly productive Senior Software Engineer with a solid systems background. In this role...SeniorWork experience placementWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior CQV Engineer. Be the first to apply!
Related searches
- senior software engineer ruby on rails Montpelier, VT
- senior customer service Montpelier, VT
- senior compensation manager Montpelier, VT
- senior manager Montpelier, VT
- senior living Montpelier, VT
- senior vmware engineer Montpelier, VT
- senior consulting engineer Montpelier, VT
- senior sas developer Montpelier, VT
- remote senior project manager Montpelier, VT
- senior Montpelier, VT