Instrumentation Specialist
About The Position
The actual location of this job is in Bend, Oregon (USA). Today, Lonza is a global leader in life sciences operating across five 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 Pharma & Biotech has an opening for an Instrumentation Specialist at their Bend, OR location. As the Instrumentation Specialist, you will be responsible for maintenance, testing, troubleshooting, calibration and repair on a variety of analytical instruments supporting Quality Control. What you will get: An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. Responsibility for maintenance, testing, troubleshooting, calibration, validation and repair on a variety of analytical instruments working with vendors and internal clients. What you will do: Develop and maintain analytical instrument validation procedures and templates related to laboratory systems to ensure compliance with regulations and GMP (Good Manufacturing Practices). Assist in the Computer System Validation of laboratory systems. Author, maintain, and execute documents such as user requirements, protocols, discrepancy reports, summary reports, change controls, CAPAs (Corrective Action/Preventive Action), usage logs, and maintenance records through site Qualify Systems. Schedules on site repair through approved vendors and hosts vendors on site. Request quotes and or purchase of specified components and maintain in inventory. Assist Subject Matter Expert and present technical expertise in regulatory audit. What we are looking for: Bachelor's degree required. Working knowledge of instrumentation, validation, and laboratory experience. Experience in maintenance/repair on analytical instruments. Experience with analytical instrument qualification. Working knowledge of GxP (Good Practice), Food and Drug Administration rules on Electronic Record/Signatures & Risk Assessment (21 CFR Part 11 & Annex 11) and USP (United States Pharmacopeial Convention, Incorporated) regulations. Experience in pharmaceutical/biotechnology or related industry. Must be able to travel between sites within Bend with own reliable transportation. 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.
Requirements
- Bachelor's degree required.
- Working knowledge of instrumentation, validation, and laboratory experience.
- Experience in maintenance/repair on analytical instruments.
- Experience with analytical instrument qualification.
- Working knowledge of GxP (Good Practice), Food and Drug Administration rules on Electronic Record/Signatures & Risk Assessment (21 CFR Part 11 & Annex 11) and USP (United States Pharmacopeial Convention, Incorporated) regulations.
- Experience in pharmaceutical/biotechnology or related industry.
- Must be able to travel between sites within Bend with own reliable transportation.
Responsibilities
- Maintenance, testing, troubleshooting, calibration, validation and repair on a variety of analytical instruments working with vendors and internal clients.
- Develop and maintain analytical instrument validation procedures and templates related to laboratory systems to ensure compliance with regulations and GMP (Good Manufacturing Practices).
- Assist in the Computer System Validation of laboratory systems.
- Author, maintain, and execute documents such as user requirements, protocols, discrepancy reports, summary reports, change controls, CAPAs (Corrective Action/Preventive Action), usage logs, and maintenance records through site Qualify Systems.
- Schedules on site repair through approved vendors and hosts vendors on site.
- Request quotes and or purchase of specified components and maintain in inventory.
- Assist Subject Matter Expert and present technical expertise in regulatory audit.
Benefits
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Medical, dental and vision insurance.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
