Lonza

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 is currently seeking an experienced CSV Lead Engineer to join their team in Portsmouth, NH.

POSITION: CSV Lead Engineer

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

CSV Lead Engineer needed by Lonza Biologics, Inc. in Portsmouth, NH [and various unanticipated locations throughout the U.S.; may work from home] to support Capital Expenditure (CAPEX) project teams during concept, design, development, start up, commissioning and qualification in close collaboration with Project Manager, Engineering, CQV Lead, Automation and Operation team. Engage with multiple parties and give clear CSV directions to the project teams while taking into account the individual project needs. Support PEP, PQP and C&Q/CSV plan development with the C&Q management for CSV related topics. Oversee CSV activities related to specific projects as needed. Identify and

evaluate preferred CSV vendors. Support the CSV COE lead with development and maintenance of standards and technologies, in all automation and control areas. Develop and manage the project CSV team. Organize the adapted CSV support for CAPEX projects, with close collaboration to operational teams and provide CSV support for CSV life cycle activities. Act as a regional key SME (Subject Matter Expert) for CSV. Support CSV COE Lead to establish and maintain validation/qualification packages for standard applications to allow off the shelf implementation. Cooperation with Global Automation, vendors and local operations to adjust packages to regional requirements. Support quality unit as the CSV SME during audit/inspections. Seek and provide continuously innovative solutions for CSV methods and ways of executing CSV considering vendor technology and internal experience. Run assessments of existing CSV methods and SOP’s in respect of robustness and adherence to health authority expectations, and to propose and execute effective CAPA should gaps be identified. Maintain compliance with all pertinent safety policies, rules, and regulations. Design and plan, budget, resource management and execution/qualification in CSV and CQV within bio-pharma industry. Utilize CSV for Automation and DeltaV Control Systems (PCS/DCS, and SCADA). Utilize cGMP/GAMP standards. Utilize Kneat. Oversee one Project Albacore CSV Lead.

MINIMUM REQUIREMENTS: Requires a Master’s degree, or foreign equivalent degree, in Information Technology Management, Computer Engineering, or Computer Science and 3 years of experience in the job offered or 3 years of experience in a related occupation designing and planning, budgeting, resource management and execution/qualification in CSV and CQV within bio-pharma industry; utilizing CSV for Automation and DeltaV Control Systems (PCS/DCS, and SCADA); utilizing cGMP/GAMP standards; and utilizing Kneat.

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.