United States, Hayward (California)
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 Process Engineer role supports ongoing operations at the Hayward, CA site through technical assistance as it relates to manufacturing and process systems. The focus of the role is on ensuring manufacturing equipment and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing. Responsibilities of the Process Engineering function include both tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business.
•Performs all work safely and meets the requisite training requirements
•Develop technical knowledge on manufacturing equipment and processes
•Manage resolution of major equipment breakdowns and quality issues in the suites
•Provide SME support to Manufacturing and other departments for the design and operation of process equipment
•Conduct troubleshooting and technical analyses on manufacturing equipment and processes
•Participates in audits and inspections as engineering SME
•Planning and execution of plant projects involving complex equipment changes and significant process improvements including capital projects
•Execute commissioning protocols (installation, operation, CIP/SIP, wet testing)
•Own change requests and complete change request tasks to support project completion
•Assist the Quality department with deviation investigations
•Participate in root cause analysis investigations for equipment issues
•Owns and executes completion of CAPA actions
•Participates in quality risk assessments
•Review/revise Engineering and Manufacturing related SOP’s, work instructions, and maintenance assessments/procedures as a result of CAPA, equipment/process changes, and error prevention activities.
•Complete engineering review/approval of batch records, deviations, commissioning protocols, and validation protocols
•Initiate updates to Engineering documents including engineering drawings
•Preferred area of study: Chemical Engineering
•Advanced years of pharma/biotech experience (or equivalent)
•Experience in the design and operation of Biopharmaceutical facilities, both manufacturing and support systems.
•Hands on experience with downstream process equipment and software including AKTAready/ Process, Pall Tangential Flow Filtration system, OSI PI and Delta V.
•Experience with control systems (PLC, DCS, Loop controllers) desirable.
•Project management and coordination experience associated with the execution of capital projects in an industrial environment is required.
•Practical experience in the management and coordination of engineering and construction management consultants, equipment vendors and contractors is required.
•Proficient with Microsoft Office Suite with focus on Outlook, Word, PowerPoint and Excel
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievement 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.