Senior CSV Lead - GMP/CGMP Systems Validation

Lonza; Portsmouth (NH); On-site; Confidential; Full time

Benefits offered by this job

Collaborative environment

Career growth opportunities

Access to cutting-edge technologies

Competitive compensation and benefits

401(k) matching plan

Mentoring and leadership support

Ethical and sustainable practices

Job summary

Lonza in Portsmouth, NH, is seeking a Computer Systems Validation Specialist III to lead CSV activities, assess new and changing computer systems, and ensure compliance with company policies and industry guidance. The role involves risk assessments, change requests, test scripts, and mentoring junior team members.

The position supports on-site work in Portsmouth NH and offers a collaborative environment, career growth, and access to cutting-edge technologies as part of Lonza's global benefits.

Qualifications

• Bachelor’s degree in computer science, engineering, or related field.
• 3+ years of experience in computer systems validation.
• 3+ years of experience in a cGMP facility.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation.

Responsibilities

• Perform all aspects of QMS processes – Change Control, Deviations, CAPAs.
• Serve as CSV project lead for projects and manage risk assessments and change requests.
• Author/Review/Approve end-to-end computer system validation life cycle deliverables.
• Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives.
• Revise and maintain SOPs for continuous improvement and compliance.

Skills

QMS knowledge

Leadership

Analytical thinking

Independent worker

Education

Bachelor’s degree in computer science/engineering or related field

Job description

Lonza in Portsmouth, NH, is seeking a Computer Systems Validation Specialist III to lead CSV activities, assess new and changing computer systems, and ensure compliance with company policies and industry guidance. The role involves risk assessments, change requests, test scripts, and mentoring junior team members.

The position supports on-site work in Portsmouth NH and offers a collaborative environment, career growth, and access to cutting-edge technologies as part of Lonza's global benefits.