Computer Systems Validation Engineer

United States, Portsmouth (New Hampshire)

Lonza is a global life sciences company operating across five continents. Our people own their careers and work together to devise ideas that help businesses and people. We are committed to ethical behavior, respect for our people and the environment, and making a meaningful difference in the world.

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 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.

Must be within (or able to relocate to) commuting range of our Portsmouth NH facility, as 100% on-site presence is required for this role

Responsibilities

• 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 Preventive 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 Operating Procedures)
• Mentor and train junior members of the department
• Level of this role is dependent on experience

Qualifications

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.

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