Senior CSV Engineer - Validation & Compliance Leader

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

Benefits offered by this job

Competitive salary

Career development opportunities

Supportive team environment

Access to cutting-edge technology

Employee well-being and safety

Inclusive workplace culture

Recognition and rewards

Job summary

Lonza in Portsmouth, NH seeks a Computer Systems Validation Engineer to lead validation efforts, ensure compliance with 21 CFR Part 11 and GAMP, and mentor junior staff. The role emphasizes risk assessment, protocol drafting, and collaboration across CSV teams.

Qualified candidates will have a minimum of 5 years in automation/validation, experience with MES/Control Systems, and DeltaV. Relocation assistance is available for eligible candidates and their families.

Qualifications

• Bachelor's degree in computer science, engineering, or related sciences.
• Minimum of 5 years of automation and/or computerized system validation experience.
• At least 2 years with Controls Automation, Process Control Systems, MES, and distributed systems; DeltaV preferred.
• Experience leading or managing projects is beneficial.
• CAPAs and deviations experience is desirable.
• Biotech/Pharma/Medical Device/biologics industry experience required.
• Ability to work independently and meet deadlines.

Responsibilities

• Lead efforts between internal customers and CSV to ensure activities are prioritized and completed on time.
• Maintain knowledge of 21 CFR Part 11, Data Integrity, ICH Q7A, and GAMP principles.
• Perform Quality Systems Management (QSM) processes and validation maintenance of computerized systems.
• Participate in audits and inspections as a Subject Matter Expert.
• Own, revise and maintain CSV SOPs.
• Function as CSV SME in inspections and audits.
• Mentor and train junior members of the department.

Education

Bachelor's degree

Tools

DeltaV

Job description

Lonza in Portsmouth, NH seeks a Computer Systems Validation Engineer to lead validation efforts, ensure compliance with 21 CFR Part 11 and GAMP, and mentor junior staff. The role emphasizes risk assessment, protocol drafting, and collaboration across CSV teams.

Qualified candidates will have a minimum of 5 years in automation/validation, experience with MES/Control Systems, and DeltaV. Relocation assistance is available for eligible candidates and their families.