Sr. Validation Engineer, Process Validation at Danaher Corporation

Fargo, North Dakota, United States

Apply Now

Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, Life Sciences, DiagnosticsIndustries

Requirements

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, or 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
10% travel to support routine inspections, audits, and customer projects

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
Provide 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
Lead the development, execution, and implementation of validation practices, policy, and procedures

Skills

Process Validation

Validation Engineering

Biological Manufacturing

Drug Substance

Drug Product

Validation Documentation

Quality Systems

Technical Operations

CDMO

Genomic Medicine

Danaher Corporation

Water quality, diagnostics, and identification solutions

About Danaher Corporation

Danaher Corporation operates in key markets such as water quality, product identification, and diagnostics. The company provides precision instruments and advanced purification technologies for analyzing and managing water, ensuring its safety in various environments. In product identification, Danaher specializes in laser marking, coding, and packaging solutions that help maintain product freshness and accurate labeling throughout the supply chain. In the diagnostics sector, Danaher offers tools and software that enhance diagnostic confidence, enabling healthcare providers to deliver effective care. What sets Danaher apart from competitors is its unique Danaher Business System, which focuses on continuous improvement and empowers employees to drive change. The company's goal is to consistently deliver high-performance products and solutions while maintaining leadership in its markets.

Washington, District of ColumbiaHeadquarters

1969Year Founded

IPOCompany Stage

Industrial & Manufacturing, Healthcare, Consumer GoodsIndustries

10,001+Employees

Risks

Increased competition from Roche and Abbott in AI-driven diagnostics.

Potential regulatory challenges in the EU for water quality sector.

Supply chain vulnerabilities affecting precision instruments sourcing.

Differentiation

Danaher's Danaher Business System drives continuous improvement and superior financial performance.

The acquisition of Cytiva enhances Danaher's capabilities in the biopharmaceutical sector.

Danaher's advanced purification technologies meet increasing demands for sustainable water management.

Upsides

Danaher's investment in AI-driven healthcare solutions boosts its diagnostics capabilities.

Cytiva acquisition expands Danaher's market share in the biopharmaceutical sector.

Point-of-care testing demand drives growth for Danaher's diagnostic tools and software.

Land your dream remote job 3x faster with AI

Try Jobo Free