Instrument and Software Specialist, Analytical Development
United States, Bend (Oregon)
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.
Lonza Pharma & Biotech has an opening for an Analytical Instrument and Software Specialist (GMP) at our Bend, OR location.
As an Analytical Instrument and Software Specialist (GMP), you will be the subject matter expert responsible for maintenance, testing, troubleshooting, calibration and repair on a variety of analytical instruments including laboratory informatic products.
The position will create and maintain necessary procedures, assist in administration, configuration and end user support of the CDS (Chromatography Data Systems), as well as provide training to staff members in a GMP (Good Manufacturing Practice) environment.
- Responsible for maintenance, testing, troubleshooting, calibration and repair on a variety of analytical equipment, and laboratory instrumentation working with vendors and the Quality Control department
- Schedule on-site repair through approved vendors and hosts vendor on-sites
- Review results from vendors, draft summary reports, submit results for approval to ensure adherence to GMP
- Maintain logs and required documentation per Standard Operating Procedures (SOPs)
- Maintain and support current CDS system
- Provide end-to-end support for issues requiring system change (requirements gathering, documentation updates, development, system configuration, validation protocol/script development to validation execution, entry and edit of all static data)
- Conduct user-training sessions for users
- Evaluates product enhancements and capabilities, in addition to implementing upgrades as required
- Author and execute Change Controls and CAPAs through our Quality System
- Use independent scientific judgment in interpretation of data
- Act as Subject Matter Expert and present technical expertise in regulatory audit
- Author investigations and root cause analysis in Quality Systems
- Minimum Bachelor’s degree required
- Experience with GMP analytical instrument qualification and computer system validations required
- Working knowledge of GMP’s, 21 CFR Part 11 & Annex 11 and USP regulations required
- Significant years of experience in maintenance/repair on analytical instruments and supporting laboratory data systems in a pharmaceutical environment
- Experience with administration and/or support of Waters Empower Oracle database, preferably with Citrix application
- HPLC/UPLC (High-Performance Liquid Chromatography), KF (Karl Fisher), USP I/II Apparati (United States Pharmacopeia), and XRD (X-ray Diffraction) and associated software experience preferred
- Experience with Agilent HPLC equipment preferred
- Experience in pharmaceutical/biotechnology or related industry
- Demonstrated attention to detail and excellent oral and written communication skills while maintaining flexibility changing priorities
- Demonstrated working understanding of laboratory operations and practices strong organizational and/or project management skills
- Strong analytical and problem-solving skills
- Must be able to work while wearing personal protective equipment as required
- Occasional heavy lifting
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.