Job Description
Job Listing ID:
4494802 Job Title:
Sr Manager, CQV Engineering Application Deadline:
06/22/2026 Job Location:
Bend
Date Posted:
05/20/2026 Hours Worked Per Week:
40 Shift:
Day Shift Duration of Job:
Full Time, more than 6 months You may contact this employer directly.
(Obtain the contact information to print or add to your jobs.) Job Summary:
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.
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. For full job description and to apply at https://www.lonza.com/careers/job-search, and enter requisition number, R76548, into the 'Search for opportunities to work with us' bar and select 'Search', or e-mail resumes to Matt Oakes at resumes.portsmouth@lonza.com and include requisition number:
R76548 in the subject line. Job Classification:
Industrial Production Managers Access our statewide or regional occupation report for more information about wages,
employment outlooks, skills, training programs, related occupations, and more. Compensation
Salary:
$125,570.00 to $166,880.00 per Year Job Requirements
Experience Required:
At least 5 years
Education Required:
Bachelors Minimum Age:
N/A
Major:
Chemistry or Chemical Engineering Gender:
N/A
