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Validation Engineer Biomedical Jobs (NOW HIRING)

Biopharma Careers

NY · On-site

$84K - $127K/yr

MilliporeSigma in Bedford, MA is hiring a Product Validation Engineer 2. As a member of the R&D ... Bachelor's degree in Chemical Engineering, Biomedical Engineering, Mechanical Engineering, Physics ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing ... Bachelor's or master's degree in biomedical engineering or related field * 2-8 years of experience ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA · On-site

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing ... Bachelor's or master's degree in biomedical engineering or related field * 2-8 years of experience ...

Alphatec Spine

Validation Engineer II

Carlsbad, CA

The Validation Engineer II is a mid-level role responsible for creating, planning, and executing ... Bachelor's or master's degree in biomedical engineering or related field * 2-8 years of experience ...

Actalent

Process Validation Engineer

Allendale, NJ · On-site

S.) in Chemical Engineering, Mechanical Engineering, Industrial Engineering, or Biomedical Engineering. * Hands-on experience with process validations, including developing and writing validation ...

Scorpion Therapeutics

NY · On-site

... or biomedical engineering preferred * Process Controls & Validation Engineer: 2+ years experience ... or Sr.: 5+ years experience; level based on experience) * Experience with process validation ...

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How much do validation engineer biomedical jobs pay per hour?

As of Sep 13, 2026, the average hourly pay for validation engineer biomedical in the United States is $52.00, according to ZipRecruiter salary data. Most workers in this role earn between $39.42 and $63.22 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.

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Validation Engineer Biomedical jobs near you
Infographic showing various Validation Engineer Biomedical job openings in the United States as of September 2026, with employment types broken down into 1% Internship, 89% Full Time, 7% Part Time, and 3% Contract. Highlights an 84% Physical, 5% Hybrid, and 11% Remote job distribution, with an average salary of $108,152 per year, or $52 per hour.

Validation Engineer

Brighton, MI • On-site

BWI Chassis Dynamics (NA) Inc.
See more jobs at BWI Chassis Dynamics (NA) Inc.external

Full-time

Re-posted 4 days ago

Key responsibilities

  • Plan, execute, and document validation activities for products and systems to ensure compliance with requirements and standards.

  • Develop validation protocols, conduct tests, analyze results, and maintain validation documentation.

  • Collaborate with engineering, quality, and operations teams during design, commissioning, and qualification of equipment and processes.

Job description

POSITION SUMMARY:
BWI Group is a premier chassis supplier that designs and manufactures brake and suspension systems for the global transportation market. BWI Group is seeking a Validation Engineer who is responsible for planning, executing, and documenting validation activities for products and systems to ensure compliance with internal requirements and external regulatory or customer standards. This role develops validation protocols, conducts tests, analyzes results, and partners with engineering, quality, and operations to maintain validated states and support audits.
JOB RESPONSIBILITIES:
  • Establish validation and qualification criteria for products and systems based on specifications and regulatory requirements.
  • Develop, review, and execute validation master plans and protocols (for example DVPRs, test plans, and traceability).
  • Create and run tests to evaluate system performance, capability, and repeatability against approved protocols.
  • Oversee calibration, verification, and maintenance of instruments and equipment used in validation activities.
  • Analyze test data using appropriate statistical methods and summarize results in validation reports with clear conclusions and recommendations.
  • Identify deviations, nonconformances, and risks; lead or support root cause investigations and implementation of corrective and preventive actions (CAPA).
  • Maintain validation documentation including protocols, reports, risk assessments, traceability matrices, and activity logs in accordance with quality system requirements.
  • Ensure systems remain in a validated state through periodic review, revalidation, and change control support.
  • Collaborate with engineering, quality, manufacturing, IT, and suppliers during design, commissioning, and qualification of new or modified equipment and processes.
  • Support internal and external audits or inspections by providing validation documentation and subject‑matter expertise.
  • Train or mentor technicians and junior team members on validation procedures, test methods, and documentation practices as needed.
  • Ensure validation activities comply with applicable regulations and standards (for example ISO 9001 and IATF 16949, and relevant product standards).
REQUIREMENT QUALIFICATIONS:
  • Bachelor’s degree in Mechanical, Electrical, Chemical, Biomedical, or related Engineering or a closely related scientific field.
  • Experience in validation, test, quality, or process engineering in a manufacturing or laboratory environment (internships or co‑ops for entry level).
  • Strong understanding of manufacturing processes, quality systems, and applicable safety or regulatory requirements.
  • Ability to develop and execute validation protocols, analyze technical data, and write clear technical reports.
  • Knowledge of statistical analysis tools or software (for example, MATLAB, Minitab, EMC, or similar).
  • Excellent attention to detail, organizational skills, and ability to manage multiple validation activities and deadlines.
  • Effective communication and teamwork skills to work across engineering, quality, and operations teams.
PREFERRED QUALIFICATIONS:
  • Experience in a regulated industry such as pharmaceuticals, biotechnology, medical devices, or automotive safety systems.
  • Familiarity with LabVIEW, Python, or other testing/analysis applications.
  • Working knowledge of relevant standards and regulations (for example ISO 9001, and automotive‑specific standards).
  • Experience with risk management tools (FMEA, risk matrices) and structured problem‑solving methodologies such as Six Sigma or Lean.
  • Project management capability, including planning validation activities, coordinating cross‑functional resources, and tracking progress.
TRAVEL REQUIRED (%):
gt;25% travel to meet customers and suppliers with day travel to various technical centers and manufacturing facilities as required.
LANGUAGE SKILLS:
Mastery of the English language and ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
MATHEMATICAL SKILLS:
Ability to apply concepts of probability and statistics, calculus, differential equations, linear algebra, and trigonometry as appropriate for data analysis, reporting and test development.
COMPUTER SKILLS:
Ability to use and understand Windows Office Suite (Word, Excel, PowerPoint, Outlook) and SharePoint. This is additional to the computer skill requirements as stated in the requirement qualifications.
REASONING ABILITY:
Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions and deal with several abstract and concrete variables. Able to read and understand engineering prints/drawings. High level of analytical skills and interpersonal skills. Ability to work on a team. Ability to guide the efforts of support personnel. Good teambuilding skills.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to walk and to sit; use hands to manipulate objects, tools, or controls; reach with hands and arms. The employee is occasionally required to stand, stoop, kneel, crouch, or crawl; and to talk and hear. The employee must occasionally lift up to 30 pounds. Specific vision abilities include close vision, color vision, peripheral vision, depth perception and the ability to focus.

WORK ENVIRONMENT:
The work environment characteristics described here are representative of those employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
For more information about BWI Group, please visit our website at www.bwigroup.com
Interested candidates, please send resume to careers@bwigroup.com and hr.us@bwigroup.com

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