Sr Manager, CQV Engineering

Position

Sr Manager, CQV Engineering – Bend, OR (63045 Corporate Place, Bend, OR 97701).

Move projects in the readiness stage from commissioning to IOQ approval and hand off to operations. Manage in-house/contracted project teams of commissioning, qualification, and validation engineers and start-up specialists to meet the organization’s CQV/Compliance requirements. Support the development of RACI matrices. 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 focus on production ramp-up rates and equipment optimization.

Define and standardize CQV best practices and processes to support full GMP readiness. Support openness to change and continuous improvement. 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 and maintain strong business understanding.

Outsource external CAPA support as needed. Support/consult with EMF teams during manufacturing emergencies and compliance remediation. Lead site Compliance/CQV work, mentor colleagues, direct vendors and service personnel. Sign as document owner on change control, engineering documentation, and validation documents. Perform commissioning, qualification, and validation activities for GMP-regulated manufacturing facilities, utilities, and equipment, authoring and executing IQ, OQ, and PQ protocols, managing deviations, and generating final reports in compliance with FDA, EMA, and ICH guidelines.

Lead projects from planning through execution and close-out, providing technical and project oversight to internal staff, external consultants, and contractor teams. Manage and direct external validation service providers, ensuring adherence to timelines, procedures, and regulatory requirements. Apply and ensure compliance with 21 CFR Part 11 requirements in the validation of computerized systems, including electronic records and signatures. Execute CSV activities according to GAMP 5 guidelines, perform cleaning validation protocols and strategies, participate in FAT and SAT of process equipment and systems, and contribute to development and maintenance of Site Master Validation Plans (SMVP) and validation policies.

Collaborate with cross-functional teams such as Engineering, Quality Assurance, MSAT, and Manufacturing to support project execution and successful equipment turnover. Lead onboarding, management, and performance oversight of contractor teams, including scheduling, compliance monitoring, and adherence to CQV best practices.

• Bachelor’s degree or foreign equivalent in Chemistry or Chemical Engineering and five (5) years of progressive, post-baccalaureate experience in CQV activities for GMP-regulated manufacturing facilities, utilities and equipment.
• Experience authoring and executing IQ, OQ, and PQ protocols, deviation management, and final report generation in compliance with FDA, EMA, and ICH guidelines.
• Leadership of CQV projects from planning through execution and close-out, providing technical and project oversight to internal staff, external consultants, and contractor teams.
• Management of external validation service providers, assigning tasks, reviewing deliverables, ensuring adherence to timelines, procedures and regulatory requirements.
• Application of 21 CFR Part 11 compliance in validation of computerized systems with electronic records and signatures.
• Execution of CSV activities per GAMP 5, risk-based validation of laboratory, manufacturing and quality systems.
• Support and execution of cleaning validation protocols and strategies, residue limits calculation, swab/rinse validation, lifecycle documentation.
• Participation in FAT and SAT of process equipment and systems, ensuring compliance with URS and design specifications.
• Contribution to development and maintenance of SMVP and validation policies aligned with corporate standards and global regulatory expectations.
• Collaboration with cross-functional teams such as Engineering, Quality Assurance, MSAT, and Manufacturing.
• Leadership of contractor onboarding, management, and performance oversight, including scheduling, compliance monitoring, and adherence to CQV best practices.

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.