Location: Muskegon,MI, USA
Be part of something altogether life-changing!
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity so you can grow your career and expand your skills in the long term.
Cytiva is one of 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development and delivery of solutions that safeguard and improve human health.
We are looking for a Validation Engineer to work with our expert engineering teams to support the multiyear construction, startup activities and then the ongoing plant operations for this world class life sciences manufacturing facility based in Muskegon, Michican. The role is expected to initially travel both within the United States and to Europe.
What youll do
As validation engineer you are responsible for coordination and execution of validation studies in accordance with current Good Manufacturing Practices. Essential responsibilities include:
+ Plan, establish and perform validation studies within regular manufacturing and projects and ensure compliance through validation and verification (V&V).
+ Perform Validation for implementation of major and minor software and equipment applications or modules Life Science Manufacturing use.
+ Write and conduct computer/equipment system/software validations (IQ/OQ/PQ) for manufacturing processes and equipment including validation requirements for new equipment and product/manufacturing changes.
+ Continuously improve ways of working within validation and participate in root cause analysis on product quality issues.
+ Responsible for representing and answering validation questions in customers audits.
Who you are
+ Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 5 years of experience in ISO9001 and 13485 Manufacturing) with a preferred 3 years of validation or quality engineering/assurance experience
+ Familiar with Quality Systems Regulations (such as FDA 21CFR820 & 21CFR210) and International Quality System Standards (like ISO9001 and 13485).
+ Working knowledge of Current Good Manufacturing Practices (cGMP), Lean Manufacturing principles, 5S and demonstrated skills in process management.
+ Ability to read and understand technical drawings.
+ Working knowledge of Excel, Word, Power Point, Minitab, Statistics.
This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Companys sole discretion, consistent with the law.
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At Danaher we bring together science, technology and operational capabilities to accelerate the real-life impact of tomorrows science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. Our global teams are pioneering whats next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit www.danaher.com.
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