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.
Responsible for leading site Compliance/CQV work, contracted teamwork, coaching and mentoring colleagues involved in CQV work and providing direction to vendors and service personnel.
Sign as document owner on change control, engineering documentation, and validation documents.
Perform Commissioning, Qualification, and Validation (CQV) activities for GMP-regulated manufacturing facilities, utilities, and equipment, including authoring and executing IQ, OQ, and PQ protocols, deviation management, and final report generation in compliance with FDA, EMA, and ICH guidelines.
Lead CQV projects from planning through execution and closeout, providing technical and project oversight to internal staff, external consultants, and contractor teams.
Manage and direct external validation service providers, including assigning tasks, reviewing deliverables, and ensuring adherence to project timelines, site procedures, and regulatory requirements.
Apply and ensure compliance with 21 CFR Part 11 requirements in the validation of computerized systems, including electronic records and electronic signatures.
Execute Computer System Validation (CSV) activities in accordance with GAMP 5 (Good Automated Manufacturing Practice) guidelines, including risk-based validation of laboratory, manufacturing, and quality systems.
Support and execute Cleaning Validation protocols and strategies, including residue limits calculation, swab/rinse method validation, and lifecycle documentation.
Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) of process equipment and systems, ensuring compliance with User Requirements Specifications (URS) and design specifications.
Contribute to the development and maintenance of Site Master Validation Plans (SMVP) and validation policies to align with corporate standards and global regulatory expectations.
Collaborate with cross-functional teams such as Engineering, Quality Assurance, MSAT, and Manufacturing to support project execution and successful equipment turnover.
Lead the onboarding, management, and performance oversight of contractor teams, including scheduling, compliance monitoring, and adherence to CQV best practices.
Supervises one (1) employee, including one (1) Sr. Process Engineer.

MINIMUM REQUIREMENTS:

Requires a Bachelor’s degree, or foreign equivalent degree in Chemistry or Chemical Engineering and five (5) years of progressive, post-baccalaureate experience in the job offered or five (5) years of progressive, post-baccalaureate experience in a related occupation performing Commissioning, Qualification, and Validation (CQV) activities for GMP-regulated manufacturing facilities, utilities, and equipment, including authoring and executing IQ, OQ, and PQ protocols, deviation management, and final report generation in compliance with FDA, EMA, and ICH guidelines; leading CQV projects from planning through execution and closeout, providing technical and project oversight to internal staff, external consultants, and contractor teams; managing and directing external validation service providers, including assigning tasks, reviewing deliverables, and ensuring adherence to project timelines, site procedures, and regulatory requirements; applying and ensuring compliance with 21 CFR Part 11 requirements in the validation of computerized systems, including electronic records and electronic signatures; executing Computer System Validation (CSV) activities in accordance with GAMP 5 (Good Automated Manufacturing Practice) guidelines, including risk-based validation of laboratory, manufacturing, and quality systems; supporting and executing Cleaning Validation protocols and strategies, including residue limits calculation, swab/rinse method validation, and lifecycle documentation; participating in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) of process equipment and systems, ensuring compliance with User Requirements Specifications (URS) and design specifications; contributing to the development and maintenance of Site Master Validation Plans (SMVP) and validation policies to align with corporate standards and global regulatory expectations; collaborating with cross-functional teams such as Engineering, Quality Assurance, MSAT, and Manufacturing to support project execution and successful equipment turnover; and leading the onboarding, management, and performance oversight of contractor teams, including scheduling, compliance monitoring, and adherence to CQV best practices.

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically. People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.