Computer Validation Specialist, Automation and Controls systems

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three 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.

The Computer Systems Validation (CSV) Specialist role supports ongoing operations at the Portsmouth NH site.  The site is conveniently located on the seacoast of New Hampshire, just 60 miles North of Boston, MA. The focus of the CSV Specialist 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 Specialist 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.

Key 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.
  • Execute all duties as assigned.
  • 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).
  • Mentor and train junior members of the department.

Key Requirements:

  • Bachelor’s degree or equivalent experience required.
  • Substantial experience in in equipment and/or computer validations.
  • Working experience with Controls Automation, Process Control Systems, Distributed Systems, Manufacturing Execution Systems (MES) required, DeltaV preferred.
  • Prior experience leading or managing projects beneficial.
  • Biotech/Pharma or biologics industry experience desired.
  • Strong attention to detail.
  • Ability to work independently and meet deadlines successfully.

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. 

Reference: R31829