Danaher - Global
Process Validation Technical Writer
This job is now closed
Job Description
- Req#: R1254699
Be the primary point of contact for clients completing process validation activities. Deliver progress updates during client meetings and manage timelines of client projects.
Generate protocols, procedures, and other project-related documents for the manufacturing process utilizing reference documentation, analysis, and cross-functional collaboration.
Design, conduct, and report findings for studies examining manufacturing processes, equipment, or technology.
Use statistical tools to design and analyze technical study data.
Support change control and risk assessment activities.
B.S./B.S.E. in Biological, Biochemical, Biomedical Engineering, or related science field.
Two or more years of experience working in a biotech or other pharmaceutical field is required. Experience in a process validation, or client-facing roles is preferred.
Strong understanding of regulatory expectations and industry standards for pharmaceutical manufacturing, and validation.
Ability to analyze data and risk to produce project / product recommendations based on scientific rationale.
Experience using statistical analysis software such as JMP
At Aldevron, we shape the future of medicine by advancing science in meaningful ways. Our team of dedicated, forward-thinking associates share this goal by combining best-in-class products and services with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. We believe people are our most valuable asset. Whether this is your first step on a rewarding career path or are a seasoned professional ready to take your career to the next level, we hire the best from all backgrounds and experiences.
Aldevron is one of the 10 Life Sciences companies of Danaher. Together, we accelerate the discovery, development, and delivery of solutions that safeguard and improve human health.This position is part of the Technical Operations Department located in Fargo, ND, and will be a hybrid role. At Aldevron, we combine best-in-class products and services with the ideal operating environment to lay the groundwork for vital new discoveries worldwide. You will be a part of the Process Validation Team and report to the Supervisor of Process Validation and be responsible for supporting internal and external Process Validation and Robustness activities with projects focused on standardization of documentation and processes, collaborating with key clients.
In this role, you will have the opportunity to:
The essential requirements of the job include:
It would be a plus if you also possess previous experience in:
At Aldevron we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Aldevron can provide.
When you join us, you’ll also be joining Danaher’s global organization, where 80,000 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 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 applyassistance@danaher.com to request accommodation.
If you’ve ever wondered what’s within you, there’s no better time to find out.About the company
Danaher Corporation is an American globally diversified conglomerate with its headquarters in Washington, DC.
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