CSV Engineer - Lead Validation & Compliance in Biotech

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits package

Career development opportunities

Supportive team environment

Access to cutting-edge technology

Employee well-being focus

Inclusive workplace culture

Job summary

Lonza Group Ltd. is seeking a Computer Systems Validation Engineer in Portsmouth, NH to identify and implement industry best practices in CSV.

You will work with the CSV team on scoping, assess risks, review change requests and test scripts, and initiate GMP documentation revisions. The role requires 5+ years in automation/validation, knowledge of 21 CFR Part 11, ICH Q7A, and GAMP, plus experience with MES and DeltaV.

Qualifications

• Bachelor’s degree in CS, engineering, or related sciences.
• Minimum 5 years in automation and/or computerized system validations.
• Minimum 2 years with Controls Automation, Process Control Systems, MES; DeltaV preferred.
• Biotech/pharma/medical device industry experience required.

Responsibilities

• Lead cross-functional CSV activities and prioritize tasks.
• Maintain knowledge of 21 CFR Part 11, Data Integrity, ICH Q7A, and GAMP.
• Perform Quality Systems Management across Change Control, Deviation, CAPA processes.
• Participate in audits as CSV SME; maintain CSV SOPs.
• Mentor junior staff in the department.

Skills

Independent work

Time management

Cross-functional collaboration

Education

Bachelor’s degree in CS/Engineering or related

Tools

DeltaV

MES

Job description

Lonza Group Ltd. is seeking a Computer Systems Validation Engineer in Portsmouth, NH to identify and implement industry best practices in CSV.

You will work with the CSV team on scoping, assess risks, review change requests and test scripts, and initiate GMP documentation revisions. The role requires 5+ years in automation/validation, knowledge of 21 CFR Part 11, ICH Q7A, and GAMP, plus experience with MES and DeltaV.