United States, Portsmouth (New Hampshire)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 focus of the CSV Engineer is to identify or create industry best practices and implement these within the framework of existing GAMP 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 Practives) documentation revisions as well as ownership of department procedures. The position provides guidance to junior team members.
- 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 QMS (Quality Management System) processes (Change Control, Deviation, CAPA) as well as Validation Maintenance of computerized systems.
- Participate in audits and inspections as a Subject Matter Expert.
- Own, revise and maintain CSV SOPs.
- Mentor and train junior members and CSV Specialists
- Execute all responsibilities as the CSV owner for significant site and process improvement projects, to ensure compliance to appropriate regulatory requirements and industry standards while maximizing efficiency.
- Oversee all CSV lifecycle activities
- Function as CSV subject matter experts in Inspections and Audits
- Bachelor’s degree or equitant experience required.
- MES and Electronic Batch Record experience required, Syncade and DeltaV preferred.
- Significant Biotech/Pharma or biologics industry experience desired.
- Knowledge of quality processes and experience with validation of computerized systems.
- Knowledge of GMP regulations.
- 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 it is 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.