Senior Validation Engineer - GMP CQV Specialist

Bristol-Myers Squibb; Bothell (WA); On-site; USD 107,000 - 130,000; Full time

Benefits offered by this job

Health Coverage

Wellbeing Programs

401(k) plan

Job summary

Bristol Myers Squibb seeks a Senior Engineer I, Validation in Bothell, WA to lead validation efforts in a GMP manufacturing environment. The role requires hands-on CQV work, regulatory interface with authorities, and collaboration across Facilities, IT, Manufacturing, QA and Quality Engineering Validation.

You will develop and implement validation strategies, manage risk assessments and drive continuous improvement while ensuring compliance with global regulations.

Qualifications

• 5+ years of commissioning, qualification and validation (CQV) experience in technical and regulated industries.
• Robust knowledge of cGMP, GDP, GXP, GAMP5 incl. 21CFR part 11 and data integrity requirements.
• Experience with equipment/utility/facility qualifications and CQV practices.
• Experience with investigations, deviations and CAPA management in a regulated pharma industry is beneficial.
• Excellent project and program management, communication and technical writing skills.

Responsibilities

• Establish validation protocols, risk assessments and qualification plans for GMP operations.
• Act as Validation SME; advise operations on validation matters and present programs to Health Authority inspectors.
• Lead qualification work for changes, capital projects and supplemental validation.
• Collaborate with cross-functional teams to manage workload, meet schedules and improve efficiency.
• Oversee qualification/validation of laboratory instruments, equipment and systems.

Skills

CQV experience

GMP knowledge

Project management

Technical writing

Regulatory interface

Education

Bachelor's degree in life sciences/engineering/STEM

Job description

Bristol Myers Squibb seeks a Senior Engineer I, Validation in Bothell, WA to lead validation efforts in a GMP manufacturing environment. The role requires hands-on CQV work, regulatory interface with authorities, and collaboration across Facilities, IT, Manufacturing, QA and Quality Engineering Validation.

You will develop and implement validation strategies, manage risk assessments and drive continuous improvement while ensuring compliance with global regulations.