Danaher Corporation Validation Engineer in Shanghai, China
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 primary focus of this position is to participate in Cytiva single-use consumable projects with prototyping, testing and verification and validation of prototypes, components, and products to ensure they meet the performance, quality, and reliability requirements. This role requires fundamental understanding of validation & verification, ability to establish processes to assemble and test the components and products safely, the application of design, root cause analysis investigation, data analysis and report writing to resolve and improve product design while working in a cross-functional team environment.
Who you are
Participate the design and develop on detailed, comprehensive and well-structured V&V test strategies, plans and protocols in ICFC NPI project; work closely with cross functional team and receive direction from project lead to achieve project deliverables.
Organize, schedule and execute verification and validation tests for single-use consumable products, components, assemblies, packaging, and fixtures.
Work in the lab testing and characterizing single-use customization products & assisting with verification & validation test efforts.
Utilize scientific principles and experience to independently execute and optimize experiments in the process of V&V. Work with internal associates and external experts to manage the challenges including unexpected experimental difficulties, technical hurdles, trouble shooting and conflicts within test project.
Operate equipment using fundamental knowledge of best test and measurement practices, such as with general evaluation, aging studies, data acquisition, tensile/load testing, and measurement diagnostics. Assure that all validation test procedures are in line with current technology, corporate and governmental regulations.
Compile test data and review results with global V&V experts to determine follow on work; identify, record, and track defects during testing; present findings to project teams.
Build prototypes and verification test samples in ICFC research lab.
Identify the right testing suppliers (both internal and external) and manage all through to achieve the best result for the quality and product launch schedule.
Create and execute packaging and system-related validation protocols and reports; perform package testing, including: leakage testing, ISTA ship testing, and IATA testing.
Work closely with manufacturing engineer and ensure knowledge transfer for any new tests or equipment.
Support quality audits to provide engineering and technical support, when requested.
Proven and progressive previous experience in validation/services/process development for single-use applications or pharmaceutical/biotech processes.
Hands-on experience designing, prototyping and testing of single-use components and assemblies is a plus.
Experience with working within an ISO 9001/13485 and/or cGMP environment.
Awareness worldwide regulatory requirements, such as: BPSA, PDA, BPOG, GMP, USP, FDA, ICH, EP, JP, ISO, REACH, ISPE and ASTM Standard.
Experience working with and managing outside vendors (CMO’s, metrology houses, testing facilities, etc.)
Knowledge of sterilization methods for pharmaceutical equipment and/or medical devices.
Minimum Bachelor’s degree in Life Science, Biomedical, or Mechanical Engineering, or related field
Minimum of three (3) years’ post academic experience in engineering, bioprocess or related field
Ability to work in a cross functional team to complete multiple varying tasks with excellent verbal and written communication, planning, organizational & interpersonal skills, and effective and analytical problem-solving capability.
Proficient with Microsoft tools; Word, Excel, Power Point, and Visio.
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 (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, 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.If you’ve ever wondered what’s within you, there’s no better time to find out.