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Validation Engineer Biomedical Jobs in Philadelphia, PA

Performing design verification and validation activities to ensure designs meet specifications ... Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or similar program (4 years of ...

Sustaining Engineer

Southampton, PA · On-site

$88K - $108K/yr

The Sustaining Engineer also leads or supports validation activities for line extensions to ... Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics/Polymer Engineering ...

Sustaining Engineer

Southampton, PA · On-site

$88K - $108K/yr

The Sustaining Engineer also leads or supports validation activities for line extensions to ... Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Plastics/Polymer Engineering ...

Sustaining Engineer

Southampton, PA · On-site

$88K - $108K/yr

The Sustaining Engineer also leads or supports validation activities for line extensions to ... Biomedical Engineering, Plastics/Polymer Engineering, or related discipline. • 3 + years in ...

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Validation Engineer Biomedical information

See Philadelphia, PA salary details

$22

$52

$78

How much do validation engineer biomedical jobs pay per hour?

As of Aug 24, 2026, the average hourly pay for validation engineer biomedical in Philadelphia, PA is $52.47, according to ZipRecruiter salary data. Most workers in this role earn between $39.76 and $63.80 per hour, depending on experience, location, and employer.

What does a validation engineer do in biomedical?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.

What are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What are some typical challenges faced by validation engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are popular job titles related to Validation Engineer Biomedical jobs in Philadelphia, PA?

For Validation Engineer Biomedical jobs in Philadelphia, PA, the most frequently searched job titles are:

What job categories do people searching Validation Engineer Biomedical jobs in Philadelphia, PA look for?

The top searched job categories for Validation Engineer Biomedical jobs in Philadelphia, PA are:

What cities near Philadelphia, PA are hiring for Validation Engineer Biomedical jobs?

Cities near Philadelphia, PA with the most Validation Engineer Biomedical job openings:

Infographic showing various Validation Engineer Biomedical job openings in Philadelphia, PA as of August 2026, with employment types broken down into 78% Full Time, and 22% Contract. Highlights an 74% In-person, and 26% Hybrid job distribution, with an average salary of $109,135 per year, or $52.5 per hour.

CQV Engineer

Stark Pharma Solutions Inc

Philadelphia, PA • On-site

Contractor

Re-posted 4 days ago


Job description

Job Title: CQV Engineer
Location: Philadelphia, PA
Duration: Long Term Contract

Job Summary

We are seeking a highly motivated CQV (Commissioning, Qualification, and Validation) Engineer to support commissioning and qualification activities within a GMP-regulated biopharmaceutical manufacturing environment. The CQV Engineer will be responsible for supporting equipment startup, system qualification, utility validation, and process readiness activities to ensure compliance with FDA, cGMP, and industry standards.

The ideal candidate will work closely with Engineering, Manufacturing, Quality Assurance, Validation, and Automation teams to support capital projects, facility expansion initiatives, and manufacturing operations.

Key Responsibilities

  • Support commissioning and qualification activities for manufacturing equipment, process systems, utilities, and cleanroom environments
  • Develop and execute commissioning and qualification documentation including FAT, SAT, IQ, OQ, and PQ protocols
  • Perform equipment qualification for biopharmaceutical manufacturing systems including upstream and downstream process equipment
  • Support utility qualification activities involving HVAC, purified water systems, clean steam, compressed gases, and environmental monitoring systems
  • Coordinate system walkdowns, punch list management, and turnover documentation activities
  • Ensure all CQV activities comply with FDA, cGMP, GDP, and company quality standards
  • Collaborate with Automation, Engineering, Validation, and Quality teams during equipment installation, startup, and qualification phases
  • Assist with deviation investigations, change control activities, and CAPA implementation related to CQV processes
  • Review P&IDs, engineering drawings, SOPs, and technical documentation to support qualification activities
  • Support technology transfer and facility expansion projects within GMP manufacturing environments
  • Participate in internal audits and regulatory inspections by providing CQV documentation and technical support

Required Qualifications

  • Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Biotechnology, or related technical field
  • 3+ years of CQV, validation, or qualification experience within biopharmaceutical, pharmaceutical, or regulated manufacturing industries
  • Strong understanding of cGMP, FDA regulations, GDP, and validation lifecycle practices
  • Experience executing IQ/OQ/PQ protocols and commissioning activities
  • Knowledge of clean utilities, HVAC systems, aseptic processing, and GMP facility operations
  • Familiarity with deviation management, CAPA, and change control systems
  • Ability to read and interpret P&IDs, engineering drawings, and technical specifications
  • Strong communication, technical writing, and problem-solving skills