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
Write and conduct computer/equipment system/software validations (IOPQ) for manufacturing and QC processes/equipment.
Generate and sustain Verification/Validation protocols and related technical documents to support the transfer of processes into QC and Manufacturing.
Write equipment risk assessments (critical component assessments), validation plans and qualification reports.
CNC & CMM programming
Manage associated qualification deviations & CAPAs, including opening, resolution, and closure
Design and perform process characterization studies and experiments using statistical methods to develop new and/or improve existing assembly processes
Conduct root cause analysis on product quality issues, identify trends, and communicate with other functional departments for resolution.
Develop, establish, and optimize quality inspection methods, test methods, and product specifications by working closed to R&D department.
Define frequency for the verification of validated equipment (preventive maintenance and/or calibration).
Partner with cross functional teams to evaluate design and processes at concept phase and define manufacturing processes.
Develop new and/or improved processes for parts through the application of theoretical and practical engineering.
Continuously developing and justifying the validation approach based on risk and scientific rational.
Act as Subject Matter Expert for the validation/qualification process for QC and Manufacturing.
Perform additional duties as required
Who you are
Master's degree in Mechanical, Biomedical Devices, Plastics Engineering, or equivalent experience with minimum of 5 years related experience in pharmaceutical or medical device
Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
Quality Management System experience
Self-starting, motivated individual with proven track record of learning new skills to achieve results.
Strong knowledge of manufacturing and laboratory systems
Experience in process development, acceptance testing and qualification of equipment.
Analytical spirit and data driven
English, French language
Project management experience
When you join us, you’ll also be joining Danaher’s global organization, where 68,000 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 is committed to a diverse and inclusive culture where everyone feels they belong and all voices are heard. We believe in our associates and the unique perspectives they bring to every challenge, which is why we’ll empower you to push the boundaries of what’s possible.
If you’ve ever wondered what’s within you, there’s no better time to find out.
We’re the Life Sciences newcomer you already know. Cytiva is bringing our long-standing expertise to the forefront of science, to fuel research, discovery, and development with technologies, instruments, and software. We drive customer-centered innovation in 11 facilities across Asia, Europe and America from idea to commercial development stages