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Qualification Services Automation Engineer (Remote Role)

Location: Little Chalfont
Company: Danaher Corporation
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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 proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we're pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
What you'll do!
The Qualification Services Automation Engineer will be responsible for the automation design of our Commissioning and Qualification products. This requires strong collaboration skills across functions and the ability to translate the customer needs into technology. A genuine interest in technology and curiosity to develop and learn is crucial in order to work in this role.
- Support Commissioning and Qualification projects for large-scale pharmaceutical production projects, as well as New Product Development.
- Analyze software changes to determine impact on current offering or requirement for additional testing.
- Design custom qualification protocols to meet URS requirements and customer expectations. FAT/SAT/IQOQ DQ/RA.
- Establish test plans to determine compliance with functional and design requirements.
- Lead project work and handle urgent tasks as they arise.
- Resolve technical questions and concerns through interaction with customers, and internal personnel.
- Collaborate and engage with multi-functional project leaders and key partners to secure qualification project work.
- Maintain budget and timelines. Identify and assess changes in scope.
- Drive continuous improvement in ways of working. Support customer meetings as needed
- Write SOP/Wi´s.
- 15-20% travel as needed.
Who you are!
- Bachelor's degree in Science, Engineering or related area or relevant work experience.
- Preferably Automation or Chemical Engineering
- Experience with Automation and Commissioning & Qualification
- Proven understanding of 21 CFR Part 11 compliance knowledge and Risk-Based Approach to Commissioning and Qualification.
- Understanding of GMP, ISO, and FDA rules and regulatory requirements.
- Experience working with upstream equipment, downstream equipment, and automation infrastructure.
- PLC programming and operations knowledge required, SCADA integration platform experience in advantage
- 2 to 3 yrs of working experience in Automation Engineering field, preferable with Wonderware, PlantPAx or DeltaV platform working experience
- Knowledge of common industrial communication protocols such as Profibus, OPC, and EtherNet/IP
- Knowledge and experience working with the project management life cycle.
- Capable of multi-functional and cross-site interactions and ability to drive project plans to completion.
- Experience in efficiently leading numerous projects/priorities and approaches to meet objectives.
- Experience with Microsoft Office Suite, Box, modular documentation, and document handling systems.
- Excellent verbal and written communication skills. Fluent in the English language.
- Willingness to travel between Cytiva and supplier sites.
Cytiva offers generous benefits package which includes medical, dental, vision insurance and matching 401K.
When you join us, you'll also be joining Danaher's global organization, where 69,000 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 require all US and Puerto Rico employees to be vaccinated against COVID-19 as a condition of employment, subject to reasonable accommodation as required by law.
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 to request accommodation. If you've ever wondered what's within you, there's no better time to find out.
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