UNKNOWN

FEED

Experience working in CDMO environment is a plusExperience using statistical, risk assessment, and process improvement toolsTravel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role10% travel to support routine inspections, audits, and customer projectsIt would be a plus if you also possess previous experience in:Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelinesAldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron's Fargo, ND site.

<p>Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?At Aldevron, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact. You'll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.At Aldevron, we deliver world-class CDMO services that accelerate the development of groundbreaking therapies. Our mission is to be the engine of innovation for genomic medicine pioneers. As a member of our team, you'll help bring life-changing innovations to life-impacting millions around the world. We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress. Whether you''re launching your career or bringing years of experience, we value the unique perspective you bring. Join us and become part of a mission-driven team advancing science and unlocking human potential-one discovery at a time.Learn about the Danaher Business System which makes everything possible.The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron's Fargo, ND site. As the subject matter expert in validation, this position leads the development, execution, and implementation of validation, practices, policy, and procedures. This position reports to the VP, Global Technical Operations and is part of the Technical Operations Department located in Fargo, ND and will be an on-site role. In this role, you will have the opportunity to:Design, execute, and oversee validation documents supporting process characterization and validation spanning biological critical starting materials, drug substance, and drug productMentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by DesignDevelop and implement validation policies and procedures based on current regulations and industry standardsProvide subject matter expertise during client and regulatory audits, kaizen and workshop events, and manufacturing supportHelp resolve quality issues and CAPA's leading lab investigations, risk assessments, root cause analysis, and developing implementation plansThe essential requirements of the job include:BS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 5+ years of experience.MS degree in biology, molecular biology, biochemistry, chemistry, or related discipline with 3+ years of experience.PhD in biology, molecular biology, biochemistry, chemistry, or related discipline with 2+ years of experience.Experience in process development, engineering, and process validation required. Experience working in CDMO environment is a plusExperience using statistical, risk assessment, and process improvement toolsTravel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role10% travel to support routine inspections, audits, and customer projectsIt would be a plus if you also possess previous experience in:Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelinesAldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com. 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.</p>

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.

Genetic Counselor Jobs in Fargo, ND

Resume Resources

Similar Job Searches

Get noticed by top employers!

Genetic Counselor Jobs in Fargo, ND

Sr. Validation Engineer, Process Validation Danaher Corp

Resume Resources

Similar Job Searches