Posted on: January 16, 2021
Help us improve access to life-changing therapies that can
transform human health We are Cytiva, a global provider of
technologies and services that advance and accelerate the
development and manufacture of therapeutics. Formerly part of GE
Healthcare, we have a rich heritage tracing back hundreds of years,
and a fresh beginning since 2020. Our customers undertake
life-saving activities. These range from fundamental biological
research to developing innovative vaccines, biologic drugs, and
novel cell and gene therapies. Our job is to supply the tools and
services - the pots, pans, soups and sauces - they need to work
better, faster and safer, leading to better patient outcomes. What
you--------ll do Quality engineers are responsible for coordination
and execution of validation studies in accordance with current Good
Manufacturing Practices. Essential responsibilities include: Lead
analysis of defect data and CAPA creation / resolution and maintain
records as specified by the Cytiva quality system. Interface with
Supplier Quality on supplier related defects. Perform Validation
for implementation of major and minor software and equipment
applications or modules for Good Manufacturing Practices (GMP) use.
Write and conduct computer/equipment system/software validations
(IQ/OQ/PQ) for manufacturing processes and equipment. Maintain
regular contact with customers to ensure products meet
expectations. Conduct root cause analysis on product quality
issues, identify trends, and communicate with other functional
departments for resolution. Reduction of MRB and non-conforming
material inventory. Develop, establish, and optimize quality
inspection methods, test methods, and product specifications.
Ensure compliance through validation and verification (V&V).
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 ISO13485 Manufacturing). Familiar with Quality
Systems Regulations (such as FDA 21CFR820 & 21CFR210) and
International Quality System Standards (like ISO13485). Strong
working knowledge of computer programming and systems (Gamp5 or
similar). Understanding of computer logic. Strong communication
skills, verbal and written. Working knowledge of Excel, Word, Power
Point, Minitab, Statistica. Ability to read and understand CAD
drawings. Some traveling may be required (less than 10% of time).
Desired Characteristics Bachelor--------s degree in engineering or
science related field 3 years of quality assurance or quality
engineering experience Green Belt Certified CQE Certification
Knowledge of 5S and Lean Manufacturing experience Strong working
knowledge of Current Good Manufacturing Practices (cGMP)
Demonstrated ability to lead Process management skills Additional
Eligibility Requirements Cytiva will only employ those who are
legally authorized to work in the United States for this opening.
Any offer of employment is conditioned upon the successful
completion of a drug screen. Who we are Whatever your role, we
bring purpose and challenge into our everyday work. If you are
driven to make the world a better place thanks to science and
medicine, you--------ll feel right at home here. If you--------re
flexible, curious and relentless, you--------ll belong. If you are
excited about a global culture, this can be the place to further
your career. Want to know more? Experience life at Cytiva on our
Careers website, Instagram channel and LinkedIn page Cytiva is a
3.3 billion USD global life sciences leader with nearly 7000
associates across 40 countries who are dedicated to our mission to
advance and accelerate therapeutics. As a trusted partner to
customers that range in scale and scope, Cytiva brings efficiencies
to research and manufacturing workflows, ensuring the development,
manufacture and delivery of transformative medicines to patients.
Cytiva is part of the Danaher family of companies, a global science
and technology innovator committed to helping customers solve
complex challenges and improving quality of life around the world.
Danaher Corporation and all Danaher Companies are equal opportunity
employers that evaluate qualified applicants without regard to
race, color, national origin, religion, sex, age, marital status,
disability, veteran status, sexual orientation, gender identity, or
other characteristics protected by law. The -------EEO is the
Law----- - poster is available here .
Keywords: Danaher, Logan , Validation Engineer, Engineering , Logan, Utah
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