Process Validation Engineer (Pharma)
Company: Danaher Corporation
Location: Fargo
Posted on: May 28, 2023
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Job Description:
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
service 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 10 Life Sciences companies of Danaher. Together,
we accelerate the discovery, development and delivery of solutions
that safeguard and improve human health.
Role Summary:
This position is part of the Validation Engineering team located in
Fargo, ND and will be on-site in North Dakota. At Aldevron, we
combine best-in-class products and service with the ideal operating
environment to lay the groundwork for vital new discoveries
worldwide.
In this role, you will have the opportunity to:
Support internal and external Process Validation and Robustness
activities with projects focused on biological drug product
manufacturing.
Support applicable ancillary validations to ensure the production
environment is compliant with regulatory requirements.
Be an active member on cross-functional teams, supporting Aldevron
initiatives.
Review validation packages for completeness and accuracy,
scientific rationale, compliance with validation policies and
procedures, and accurate data analysis. Compare results against
acceptance criteria and lead the resolution of deviations. Act
independently to execute approved resolutions. Recommend to QA the
release of qualified systems.
Write and review validation documents related to facilities, drug
product, cleaning or process validation systems comprising check
for compliance with corporate standards, regulatory requirements,
and technical expertise. Lead cross functional review and
implementation / execution of documentation with clients or
internal stakeholders.
Compile, maintain, analyze and make recommendations for
value-generating solutions based on data from multiple sources
supporting R&D, engineering and validation work. Execute
solutions independently.
The essential requirements of the role include:
B.A. or B.S. in Biology, Biochemistry, Engineering, or related
science with a minimum of 5 years of experience in GMP drug product
manufacturing -OR- a Master's with 3 years of experience.
At least 1+ years of experience with Cleaning Validation, Process
Validation and/or Media Fill Simulation.
Key attributes and skills desired:
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
(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
applyassistance@danaher.com to request accommodation. If you've
ever wondered what's within you, there's no better time to find
out.
Keywords: Danaher Corporation, Fargo , Process Validation Engineer (Pharma), Engineering , Fargo, North Dakota
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