QA Validation Manager, Computer Systems

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.

Lonza Portsmouth, is looking for QA Validation Manager, Computer Systems to support our QA Computer Systems Validation (CSV) group.

POSITION:                 QA Validation Manager, Computer Systems

JOB LOCATION:      101 International Drive, Portsmouth, NH 03801 [and various unanticipated locations throughout the U.S.; may work from home]

QA Validation Manager, Computer Systems needed by Lonza Biologics, Inc. in Portsmouth, NH [and various unanticipated locations throughout the U.S.; may work from home] to ensure computerized systems utilized in the Good Manufacturing Practices (GMP) manufacture of biopharmaceuticals are appropriately qualified and are maintained in a validated state as defined in the Computerized Systems Validation Master Plan. Manage and plan the work of the computerized system validation team, assess workload, and manage resource deployment to meet project timelines. Provide guidance and resource planning for both routine operations and capital project validation activities. Identify efficiencies and process improvements in the Computer Systems Validation (CSV) program approach. Apply lessons learned and stay informed of industry regulatory changes. Develop and maintain computer validation master plan, validation protocols, and project plans. Review and approve completed protocols and reports for completeness, Current Good Manufacturing Practices (cGMP) compliance, and acceptability of data. Develop, train, coach, and mentor direct reports on validation team in areas of technical expertise, task management, and leadership. Present and defend the computer systems validation program and acceptance criteria to clients and regulators. Review and revise the validation master to ensure GMP compliance with applicable regulations, guidelines, and best practices. Establish and maintain validation maintenance program for the computer systems validation group. Apply knowledge as System Matter Expert (SME) for CSV Program. Ensure data integrity requirements for computerized systems are met as per Company Policies. Oversee two Computers Systems Validation Engineers, one Computer

Systems Validation Lead, one QA Computer Systems Validation Specialist, two QA Computer Systems Validation Specialists Level 2, and three QA Computer Systems Validation Specialists Level 3.    

MINIMUM REQUIREMENTS: Requires a Master’s degree, or foreign equivalent degree, in Chemical Engineering, Computer Science, Engineering, or Biotechnology and 3 years of experience in the job offered or 3 years of experience in a related occupation developing, training, coaching, and mentoring direct reports on validation team in areas of technical expertise, task management, and leadership; establishing and maintaining computer systems validation group; and applying knowledge as System Matter Expert (SME) for CSV Program.

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.