Engineer II, Process Validation at Danaher Corporation

Fargo, North Dakota, United States

Danaher Corporation Logo
Not SpecifiedCompensation
Mid-level (3 to 4 years)Experience Level
Full TimeJob Type
UnknownVisa
Life Sciences, BiotechnologyIndustries

Requirements

  • Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) and 4+ years of experience in process development and/or technology transfer OR Associate degree in Engineering Technology or related field with 6+ years of process development experience in a life sciences company
  • Knowledge of regulatory and cGMP regulations for pharmaceutical manufacturing operations and validation procedures and practices

Responsibilities

  • Develop and review validation documents for facilities, equipment, and processes
  • Ensure all documents comply with corporate standards and regulatory requirements
  • Collaborate on experiments for new or modified manufacturing processes and equipment
  • Analyze critical data and provide informed recommendations
  • Support all phases of the validation life cycle, including research, development, and continuous monitoring

Skills

Process Validation
Validation Documentation
Regulatory Compliance
Process Development
Technology Transfer
Data Analysis
Manufacturing Processes
Equipment Validation
Facilities Validation
GMP

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.

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