Computer Systems Validation Engineer

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

Computer Systems Validation Engineer Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. The Computer Systems Validation (CSV) Engineer will, as an individual contributor, identify and implement industry best practices through an extensive industry network and detailed knowledge of applicable regulations. During the scoping portion of these improvement projects the person in this role will work with other experienced members of the CSV team to identify roadblocks and additional efficiencies. Additional day to day tasks will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions.

What you will get:

• Competitive salary and comprehensive benefits package.
• Opportunities for career development and advancement.
• Supportive and collaborative team environment.
• Access to cutting-edge technology and tools.
• Commitment to employee well-being and safety.
• Inclusive workplace culture.
• Recognition and reward for your contributions.
• Access to our full list of global benefits: https://www.lonza.com/careers/benefits

What you will do:

• Lead efforts between internal customers and CSV to ensure assigned activities are prioritized, communicated in an effective and timely manner, and completed on time.
• Accountable for maintaining full knowledge of Lonza's policies/procedures, 21 CFR Part 11, Data Integrity, ICH Q7A requirements and GAMP and the underlying principles of each.
• Perform all aspects of Quality Systems Management (QSM) processes (Change Control, Deviation, Corrective and Preventable Actions) as well as Validation Maintenance of computerized systems.
• Participate in audits and inspections as a Subject Matter Expert.
• Own, revise and maintain computer systems validation SOPs (Standard Operations Procedures).
• Function as CSV SME in Inspections and Audits.
• Mentor and train junior members of the department.

What we are looking for:

• Bachelor’s degree required, preferred in computer science, engineering, or other sciences.
• Minimum of 5 years of experience working with automation and/or computerized system validations.
• Minimum 2 years’ experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred.
• Prior experience leading or managing projects beneficial.
• CAPAs and deviations experience desired.
• Biotech/Pharma/Medical Device/Medical or biologics industry experience required.
• Ability to work independently and meet deadlines successfully.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board. Ready to shape the future of life sciences?