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About the Role
Aldevron, a Danaher company, delivers 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.
Responsibilities
- Design, execute, and summarize deliverables across the three stages of process validation supporting process characterization and qualification spanning critical starting materials, drug substance, and drug product, product classifications aligned with FDA guidance, EU GMP Annex 15, and lifecycle approach.
- Lead the planning, execution, and lifecycle management of sterile fill-finish process validation strategies and qualification programs for aseptic manufacturing processes including sterile filtration, aseptic process simulation, sterile filling, visual inspection, container closure integrity testing, filter validation, labelling, packaging and shipping.
- Drive risk-based approaches using tools such as pFMEA, risk ranking, and criticality assessments and apply statistical tools to evaluate process performance, including but not limited to process capability, trend analysis and control charts and DOE) interpretation.
- Serve as a technical SME for process validation with external clients, across internal teams such as MSAT, manufacturing, QC, QA and RA, and during client audits and regulatory inspections, kaizens and workshop events.
- Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design
Requirements
- Bachelor or master degree in engineering and 5+ years of experience
- Prior experience in leading process development, engineering, and deliverables across all three stages of process validation in biologics/small and large molecules manufacturing train using statistical analysis, risk assessment, and process improvement tools required.
- Knowledge of global regulatory requirements and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices.
- Proficiency in technical writing with deviation investigations, root cause analysis, and risk assessments.
- Ability to travel 15% to site to support validation project executions, routine inspections, audits, and client visits.
Skills
- Process validation
- Process characterization
- Process qualification
- Sterile fill-finish process validation
- Aseptic manufacturing processes
- Sterile filtration
- Aseptic process simulation
- Visual inspection
- Container closure integrity testing
- Filter validation
- Labelling
- Packaging
- Shipping
- pFMEA
- Risk ranking
- Criticality assessments
- Statistical tools
- Process capability
- Trend analysis
- Control charts
- DOE interpretation
- cGMP regulations
- Quality by Design
- Deviation investigations
- Root cause analysis
- Risk assessments
Location
- Fargo, ND
Work Type
- Fully remote
- Remote
Experience Level
- Senior
Education Level
- Bachelor degree
- Master degree
Salary/Compensations
- $100,000 to $130,000
Benefits
- Paid time off
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k)
About the Company
- 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.
- 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.
- We bring together deep scientific expertise, an unwavering commitment to quality, and a collaborative spirit to drive progress.
- Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives.
- We believe in designing a better, more sustainable workforce.
- We recognize the benefits of flexible, remote working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement.
- For more information, visit www.danaher.com.
Equal Opportunity
- 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.