Computer Systems Validation Engineer

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

Job Summary

The Computer Systems Validation (CSV) Engineer role supports ongoing operations at the Portsmouth NH site. The focus of the CSV Engineer role is to identify or create industry best practices and implement these within the framework of existing GAMP (Good Automated Manufacturing Process) regulations. Responsibilities of the CSV Engineer will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP (Good Manufacturing) documentation revisions as well as ownership of department procedures. The position provides guidance to junior team members.

What you will get

• A collaborative and inclusive work environment

• Opportunities for career growth and development

• Access to cutting-edge technologies and tools

• Competitive compensation and benefits package

• Supportive leadership and mentoring

• Commitment to ethical and sustainable practices

• Relocation support if required

What you will do

• Coordinate with internal teams to prioritize and complete CSV activities on time

• Ensure compliance with Lonza policies and industry regulations including GAMP and 21 CFR Part 11

• Manage Quality Systems processes such as change control and validation maintenance

• Participate in audits and inspections as a subject matter expert

• Maintain and revise computer systems validation procedures

• Mentor and train junior team members

• Support on-site operations at our Portsmouth NH facility

What we are looking for

• Bachelor's degree in computer science, engineering, or related field

• At least 4 years of experience in automation or system validation

• 2+ years with Programmable Logic Controllers (PLC), Controls Automation, Process Control Systems, SCADA Systems, Distributed Controls Systems (DCS), Building Alarm Systems (BAS), Building Management Systems (BMS), Manufacturing Execution Systems (MES) required, DeltaV is preferred

• Experience leading projects and managing CAPAs and deviations

• Background in biotech, pharma, or medical device industry

• Strong attention to detail and ability to meet deadlines

• Ability to work independently and on-site in Portsmouth NH

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.