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.
Our new Chromatography Media Manufacturing site in Muskegon Michigan, is looking for an experienced QA professional with product release experience to verify products meet quality standards and requirements. You will be part of our ongoing security of supply initiative to build a new chromatography media manufacturing site and product transfer from our manufacturing site in Uppsala Sweden.
What you'll do:
- Review and approve equipment Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ), and process validation (PV) protocols.
- Assist with deviation investigations, corrective and preventative actions (CAPAs), and change controls related to equipment qualification and validation activities.
- Maintain ownership of the Muskegon Site Master Validation Plan.
- Improve and develop QMS work instructions.
- Participate in quality walks and internal audits to ensure compliance with industry standards.
Who you are:
- Bachelor's degree from an accredited University or College, preferably in a Science or Engineering discipline.
- Working experience in Quality Assurance/Quality Engineering.
- Validation experience in equipment qualifications, process validations, and cleaning validations preferred.
- Understanding of ISO 9001 requirements. Understanding of GMP requirements, desired.
- Experience within Life Science, Pharmaceutical, Medical Device or Biopharma manufacturing environments preferred.
It would be a plus if you also possess previous experience in:
- Analytical and problem-solving skills.
- Strong communication skills (written and oral) with associates at all levels of the organization.
- Microsoft Office skills (Outlook, Word, Excel, PowerPoint) and Oracle.
At Cytiva we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Cytiva can provide.
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 Company's sole discretion, consistent with the law.
When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.
The EEO posters are available here.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at applyassistance@danaher.com to request accommodation.
If you've ever wondered what's within you, there's no better time to find out.