Sr. Validation Engineer, Process Validation
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 Danahers 15 operating companies our work saves livesand were all united by a shared commitment to innovate for tangible impact.
Youll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danahers 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 youll help bring life-changing innovations to lifeimpacting millions around the world. We bring together deep scientific expertise an unwavering commitment to quality and a collaborative spirit to drive progress. Whether youre 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 potentialone 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 Aldevrons 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 product
Mentor junior validation associates in Process Validation cGMP regulations and principles of Quality by Design
Develop and implement validation policies and procedures based on current regulations and industry standards
Provide subject matter expertise during client and regulatory audits kaizen and workshop events and manufacturing support
Help resolve quality issues and CAPAs leading lab investigations risk assessments root cause analysis and developing implementation plans
The essential requirements of the job include:
Bachelors degree in Engineering or Scientific field (preferably Chemical Biology or Microbiology) with 5 years of experience or MS degree with 3 years of experience.
PhD in Engineering or Scientific field with 2 years of experience.
Experience in process development engineering and process validation required. Experience working in CDMO environment is a plus
Experience using statistical risk assessment and process improvement tools
Travel Motor Vehicle Record & Physical/Environment Requirements: if applicable for role
10% travel to support routine inspections audits and customer projects
It 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 guidelines
Aldevron a Danaher operating company offers a broad array of comprehensive competitive benefit programs that add value to our lives. Whether its a health care program or paid time off our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
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Join our winning team today. Together well accelerate the real-life impact of tomorrows 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 .
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.
The U.S. EEO posters are available here.
We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process to perform essential job functions and/or to receive other benefits and privileges of employment please contact:1- or .
Required Experience:
Senior IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
WHO WE ARE We are a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world. These are the moments that make a difference. Performing a delicate operation on an unborn baby. Minimizing waste at ever ... View more
