Model Risk Analyst III - Validation
M&T Bank$82,783 - $137,972/year
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Life Sciences, Diagnostics, BiotechnologyIndustries
Requirements
- Bachelor’s degree in a relevant field with 5+ years of experience, OR Master’s degree in a relevant field with 3+ years of experience, OR Doctoral degree in field
- Experience in software, test method, equipment, process, and/or design testing methodologies
- Knowledge of FDA regulations, ISO standards, and GxP guidelines
- Experience with Computer System Validation (CSV) and process validation
Responsibilities
- Train and mentor individuals and validation teams (both formal classroom and informal) to ensure efficiency and compliance with validation regulations and corporate procedures
- Evaluate specifications for requirements and ensure they meet validation standards
- Generate test cases and procedures from specifications with minimal guidance
- Execute test procedures with minimal guidance and document results accurately
- Apply Danaher Business System tools to make continuous improvements across the business
- Assist in the sustainment of a robust Master Validation Plan and support of the MVP strategies
Skills
QA Validation
Master Validation Plan
Validation Strategies
Training
Mentoring
Quality Assurance
Compliance
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.
Related Jobs
RemoteRemoteQuality Assurance Engineer II
JenzabarSalary not specified
- Full Time
- Junior (1 to 2 years)
RemoteSoftware Development Engineer in Test IV
OpenXSalary not specified
- Full Time
- Expert & Leadership (9+ years)
RemoteQuality Assurance Specialist
OkloSalary not specified
- Full Time
- Junior (1 to 2 years)
RemoteSenior Test Engineer
RacknerSalary not specified
- Full Time
- Senior (5 to 8 years)
RemoteTechnical Lead - Validation, Tools, and Acceleration (VTA)
General MotorsSalary not specified
- Full Time
- Expert & Leadership (9+ years)