Validation Engineer at Danaher Corporation

Ängelholm, Skane County, Sweden

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medtech, Diagnostics, Biotechnology, Life SciencesIndustries

Requirements

University degree in engineering or equivalent, with experience in similar positions
Knowledge of FDA, CFR Part 820, and ISO 13485
Broad validation experience, minimum 3 years
Ability to apply statistical methods to practical problems

Responsibilities

Lead and ensure process validations, including validation of methods (instrumentation) and software systems (both instrument and production environments)
Plan and perform measurement system analyses
Guide colleagues on validation matters
Take the lead in executing and documenting validation activities
Assist during audits regarding process validation-related questions
Design and conduct experiments to improve manufacturing processes
Use statistical methods as a basis for decision-making

Skills

Key technologies and capabilities for this role

Process ValidationCalibrationMeasurement System AnalysisInstrumentation ValidationSoftware ValidationMethod Validation

Questions & Answers

Common questions about this position

Is this position remote or on-site?

This position is on-site and located in Ängelholm as part of the Integrated Engineering within operations.

What are the essential requirements for this Validation Engineer role?

Candidates need a university degree in engineering or equivalent with experience in similar positions, knowledge of FDA, CFR Part 820, and ISO 13485, broad validation experience of at least 3 years, and the ability to apply statistical methods to practical problems.

What is the salary for this position?

This information is not specified in the job description.

What is the company culture like at HemoCue?

HemoCue fosters a culture of belonging where unique viewpoints matter, continuous improvement, and a clear purpose of advancing care test by test, everywhere, with care as the bedrock in devices, people, and interactions.

What makes a strong candidate for this Validation Engineer position?

A strong candidate thrives in a senior validation role, has previous experience in measurement technology or vision systems, and is ready to lead process validations, guide colleagues, and contribute to building a world-class medtech production organization.

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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