Lonza Pharma & Biotech is seeking a QA Validation Engineer for their Bend, Oregon site.
The QA Validation Engineer will support all validation activities and plant GMP systems for the site, reporting to the Manager, QA Validation. The successful candidate will thrive in a fast paced, dynamic environment and have demonstrated ability to maintain tight timelines.
Key Responsibilities:
Oversee the Process Validation and Equipment Qualification program at the Lonza, Bend Site.
Maintain and administer the change control & validation program and procedures, the validation library and revalidation schedule
Act as a validation subject-matter expert to provide consistency in the validation approach for equipment, systems, computers, methods and processes
Provide validation guidance/training to internal and external customers and support cross-functional validation efforts for technology transfer
Maintain the Validation Master Plan
Perform and/or support validation activities, and trend, analyze, and interpret data to monitor performance and support revalidation decisions for changes
Perform gap analysis on current validation practices and regulatory requirements and remediate as necessary
Create and revise quality system procedures, forms and equipment specifications
Perform deviation investigations and resolutions through the CAPA system
Provide direction to vendors
Oversee validation activities execution and advise on course of action for problem resolution
Participate on project teams responsible for scale-up and technology transfer
Act as system administrator for selected computerized systems.
Key Requirements:
B.S./B.A. degree in a scientific, computer or engineering field preferred or equivalent education and work experience
3-5 years relevant work experience; experience in the pharmaceutical or biotech industry highly desired
Previous experience working with validation activities, including computer systems validation (CSV), cleaning validation, equipment qualification, and technology transfers is highly desirable.
Working knowledge of CAPA investigations and resolutions
Experience working with vendors highly desired
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.
