Lonza
life sciences
SrManager,CQVEngineering
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“Sr Manager, CQV Engineering at Lonza. Skills: CQV Engineering, GMP Compliance, Validation Protocols, Team Leadership. Move projects from commissioning to IOQ approval. Manage project teams”
What You'll Achieve.
Meet organization’s CQV/Compliance requirements; Focus on production ramp up rates; Equipment optimization; Support full GMP readiness; Support project execution; Successful equipment turnover
Industry & Context.
Solving complex problems
What They're Looking For.
Must Have
Bachelor’s degree in Chemistry or Chemical Engineering, 5 years of progressive, post-baccalaureate experience in Commissioning, Qualification, and Validation (CQV) activities for GMP-regulated manufacturing facilities, utilities, and equipment, authoring and executing IQ, OQ, and PQ protocols, deviation management, final report generation in compliance with FDA, EMA, and ICH, leading CQV projects from planning through execution and closeout, providing technical and project oversight to internal staff, external consultants, and contractor, managing and directing external validation service providers, assigning tasks, reviewing deliverables, ensuring adherence to project timelines, site procedures, and regulatory, applying and ensuring compliance with 21 CFR Part 11 requirements in the validation of computerized systems, executing Computer System Validation (CSV) activities in accordance with GAMP 5 guidelines, risk-based validation of laboratory, manufacturing, and quality systems, supporting and executing Cleaning Validation protocols and strategies, participating in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), contributing to the development and maintenance of Site Master Validation Plans (SMVP) and validation policies, collaborating with cross-functional teams such as Engineering, Quality Assurance, MSAT, and Manufacturing, leading the onboarding, management, and performance oversight of contractor teams, scheduling, compliance monitoring, adherence to CQV best practices
What You'll Do.
Move projects from commissioning to IOQ approval
Support RACI matrices development
Provide status updates to PMs
Ensure seamless transfer to operations
Define and standardize CQV best practices
Prepare and execute change controls
Execute validation protocols
Perform CQV activities
Manage external validation service providers
Apply 21 CFR Part 11 requirements
Execute CSV activities
Support Cleaning Validation protocols
Participate in FAT and SAT
Contribute to SMVP development
Lead contractor team onboarding
How You'll Work.
Team & Collaboration
Work in conjunction with process engineering team; Collaborate with cross-functional teams; Work with Engineering; Work with Quality Assurance; Work with MSAT; Work with Manufacturing
Communication Scope
Communicate internally and externally at higher levels; Business understanding
Process & Methodology
Project oversight, Task assignment, Deliverable review, Timeline adherence, Project execution
Full Job Description
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Lonza is currently seeking an experienced Sr. Manager, CQV Engineering to join their team in Bend, OR. POSITION: Sr Manager, CQV Engineering JOB LOCATION:**** 63045 Corporate Place, Bend, OR 97701 DUTIES: Move projects in the readiness stage from commissioning to IOQ approval and handed off to operations. Manage in-house/contracted project teams of commissioning, qualification, and validation engineers and start-up specialists to meet organization’s CQV/Compliance requirements. In addition to CQV deliverables, support the development of RACI matrices to help all teams understand roles and responsibilities. Work in close conjunction with the process engineering team and provide status updates to project PMs. Ensure seamless transfer from OQ handoff to operations/MSAT with a focus on production ramp up rates and equipment optimization. Define and standardize CQV best practices and processes that support full GMP readiness. Support and promote an openness for change and new ideas, cooperative teamwork and continuous improvement even outside the CQV area of responsibility. Onboard contractor teams through Lonza job codes. Lead check-in meetings with contractor leadership teams. Prepare and execute change controls and validation protocols for new and existing GMP equipment. Communicate internally and externally at higher levels, strong business understanding. Outsource external CAPA support as necessary to support the process engineering team deliverables. Support/consult with EMF teams during manufacturing emergencies and compliance remediation.
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