Sr Manager, CQV Engineering

Lonza•Bend, OR

13d•Onsite

About The Position

Lonza is a global leader in life sciences operating across three continents. The company is seeking an experienced Sr. Manager, CQV Engineering to join their team in Bend, OR. This role involves moving projects from the commissioning stage to IOQ approval and handover to operations, managing project teams, and ensuring compliance with CQV/Compliance requirements. The position also focuses on defining and standardizing CQV best practices, supporting change and continuous improvement, and collaborating with various cross-functional teams. Lonza offers a challenging and creative environment for solving complex problems in life sciences, with the satisfaction of improving lives worldwide.

Requirements

Bachelor’s degree, or foreign equivalent degree in Chemistry or Chemical Engineering
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
Leading the onboarding, management, and performance oversight of contractor teams, including scheduling, compliance monitoring, and adherence to CQV best practices

Responsibilities

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.
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.