Aldevron · 14 hours ago
Sr. Validation Engineer, Process Validation
Fargo, ND
Full-time
Onsite
Senior Level
5+ years expAldevron is a company committed to innovating within life sciences, diagnostics, and biotechnology. The Senior Validation Engineer, Process Validation role involves providing expertise and guidance in the validation programs for biological critical starting materials, drug substances, and drug products, while mentoring junior associates and developing validation policies and procedures.
BiotechnologyCommercialIndustrialManufacturing
Responsibilities
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 CAPA’s leading lab investigations, risk assessments, root cause analysis, and developing implementation plans
Qualification
Required
Bachelor's 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 using statistical, risk assessment, and process improvement tools
Preferred
Experience working in CDMO environment is a plus
Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines
Benefits
Comprehensive, competitive benefit programs
Health care program
Paid time off
Company
Aldevron
Aldevron is a biological development and manufacturing organization specializing in cell and genetic engineering.
1001-5000 employees
H1B Sponsorship
Aldevron has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (10)
2024 (8)
2023 (10)
2022 (6)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
TA Associates
2021-06-17Acquired
2019-01-01Private Equity
2017-01-24Private Equity
Leadership Team
Kevin Ballinger
Chief Executive Officer
Nathan Spangler
Senior Director, IVT mRNA Services Platform
Recent News
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