Danaher Corporation Equipment Validation Engineer in Newark, California
At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation to development and delivery of testing advancements that improve patient outcomes across a range of settings. As a member of our team, you can make an immediate, measurable impact on a global scale, within an environment that fosters career growth and development.
Cepheid is proud to work alongside a community of six fellow Danaher Diagnostics companies. Together, we’re working at the pace of change on diagnostic tools that address the world’s biggest health challenges, driven by knowing that behind every test there is a patient waiting.
The Equipment Validation Engineer is responsible for defining and executing validation strategy and coordinating validation activities required to launch new equipment into the production environment. The successful candidate will perform validation activities that include Equipment/Utility/Facility Qualification, Cleaning Validation, and Automation System Qualification across the entire validation lifecycle from Plan to Retire. Work with a cross functional team to support manufacturing capacity expansion projects.
ESSENTIAL JOB RESPONSIBILITIES:
Design and perform process characterization studies and experiments using statistical methods to develop new and/or improve existing assembly processes.
Validate new automation processes, equipment and/or designs in collaboration with a diverse functional engineering team.
Generate and sustain Verification/Validation protocols (I/OQ, PQ) and related technical documents to support the transfer of processes into Production.
Provide technical assessment and validation review/approval for engineering, process and standard operating procedure changes.
Assist in failure investigations and root cause analyses as they relate to process performance.
- Complete all assigned and required training satisfactorily and on time
Education and Experience (in years):
Bachelor’s degree in field with 5+ years of related work experience OR
Master’s degree in field with 3+ years of related work experience OR
Doctoral degree in field with 0-2 years of related work experience.
Knowledge and skills:
Strong working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
Strong data analysis skills utilizing software such as MiniTAB and JMP.
Proven experience with DOE’s, root cause analysis, process engineering, failure investigations and automated assembly equipment.
Experience developing and executing IQ, OQ and PQ documentation for GMP equipment.
Excellent verbal and written communication skills.
Familiar with statistical process control methods.
Ability to work in clean room environment.
Ability to use hand or power tools.
Ability to stoop, kneel, crawl, lift, push
BS in Mechanical, Biomedical Devices, Plastics Engineering (or a related field).
MS degree in Mechanical, Biomedical Devices, Plastics Engineering (or a related field).
A minimum of 3+ years engineering experience in medical device or other regulated industry.
Prior experience in biomedical device assembly process development.
Quality Management System experience.
The statements in this description represent typical elements, criteria and general work performed. They are not intended to be an exhaustive list of all responsibilities, duties, and skills for this job.
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.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 (https://www.dol.gov/agencies/ofccp/posters) .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 email@example.com to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.
Operating Company: Cepheid