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Validation Engineer Biomedical Jobs in Texas (NOW HIRING)

Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline. * Minimum of 3-5 years of experience in validation within the biopharmaceutical ...

We are looking for a passionate Biomedical Engineer to join our growing team and help design ... Use validated segmentation software to convert patient scan data into 3D anatomical models for ...

Responsibilities include developing, optimizing, and validating manufacturing processes to uphold quality standards. Candidates must hold a Bachelor's or Master's degree in Biomedical Engineering ...

Responsibilities include developing, optimizing, and validating manufacturing processes to uphold quality standards. Candidates must hold a Bachelor's or Master's degree in Biomedical Engineering ...

Senior Biomedical Engineer (USA)

Houston, TX · On-site +1

$99K - $137K/yr

We are looking for a passionate Senior Biomedical Engineer to join our growing team and help design ... Use validated segmentation software to convert patient scan data into 3D anatomical models for ...

Biomedical Technician 1 - Paris, Texas

Paris, TX · On-site +1

$19.25 - $25.50/hr

Qualifications: * Associate's or Bachelor's degree in Electrical Engineering, Biomedical ... Valid driver's license and ability to maintain license. * The successful applicant must comply with ...

Field Service Specialist

Houston, TX · On-site

$37.40 - $55.63/hr

... Engineering, Biomedical or Mechanical Engineering or related field, equivalent military education, or Technical School graduate of technical program or training validated through training ...

Biomedical Technician 1

El Paso, TX · On-site

$22.75 - $30.25/hr

S. * Electronics, Biomedical Engineering, Medical Imaging Technology, Mechanical Principles, or ... valid driver's license. • Special Physical Requirements: Candidate must be able to lift, carry ...

Biomedical Technician 1

El Paso, TX · On-site

$22.75 - $30.25/hr

S. * Electronics, Biomedical Engineering, Medical Imaging Technology, Mechanical Principles, or ... Must have reliable transportation and a valid driver's license. Special Physical Requirements:

Sustaining Engineer I

Austin, TX

$91K - $112K/yr

COMPANY OriGen Biomedical, Inc., is a global leader in cryopreservation and cell culture. We ... Consult with marketing and regulatory to identify new markets for devices and plan new validation ...

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Showing results 1-20

Validation Engineer Biomedical information

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 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 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 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 popular job titles related to Validation Engineer Biomedical jobs in Texas? For Validation Engineer Biomedical jobs in Texas, the most frequently searched job titles are:
What job categories do people searching Validation Engineer Biomedical jobs in Texas look for? The top searched job categories for Validation Engineer Biomedical jobs in Texas are:
What cities in Texas are hiring for Validation Engineer Biomedical jobs? Cities in Texas with the most Validation Engineer Biomedical job openings:

Validation Engineer

Lonza

Houston, TX • On-site

Full-time

This job post has expired 1 day ago. Applications are no longer accepted.


Lonza rating

8.3

Company rating: 8.3 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

24th of 86 rated pharmaceutical


Job description

Validation Engineer

Houston, TX

The actual location of this job is in Houston, TX, US. Relocation assistance is available for eligible candidates and their families, if needed.

This is a fully sitebased role. Working together in person supports close, realtime collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.

What you will get:

  • An agile career and dynamic working culture.

  • An inclusive and ethical workplace.

  • Compensation programs that recognize high performance.

  • A variety of benefits dependent on role and location.

The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.

What you will do:

  • Develop and execute validation protocols and reports for equipment, utilities, facilities. (e.g., IQ, OQ, PQ).

  • Develop and execute CQV deliverables for Sterilization program. Experience in autoclave cycle development, load development and qualification.

  • Perform risk assessments and develop validation strategies based on regulatory guidelines (e.g., FDA, EMA) and industry best practices.

  • Coordinate validation activities with cross-functional teams including Manufacturing, Quality Assurance, Engineering, and R&D.

  • Analyze validation data, identify deviations, and recommend corrective and preventive actions (CAPAs).

  • Prepare and present validation summaries and reports to internal and external auditors.

  • Participate in the review and approval of change controls related to validated systems.

  • Maintain validation plans and schedules to ensure timely completion of validation activities.

  • Support regulatory inspections and internal audits by providing validation documentation and expertise.

  • Contribute to the continuous improvement of validation processes and procedures.

What we are looking for:

  • Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.

  • Minimum of 3-5 years of experience in validation within the biopharmaceutical or pharmaceutical industry.

  • In-depth knowledge of cGMP, ICH guidelines, FDA regulations (21 CFR Parts 210, 211, 820), and other relevant regulatory requirements.

  • Ideal candidates will have hands-on experience in autoclave validation and familiarity with FDA and cGMP standards. Proven experience with IQ, OQ, PQ.

  • Strong understanding of quality systems (e.g., change control, deviations, CAPA).

  • Excellent technical writing and communication skills.

  • Ability to work independently and collaboratively in a fast-paced environment.

About Lonza

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone's ideas, big or small, have the potential to improve millions of lives, and that's the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we value diversity and are committed to creating an inclusive environment for all employees. If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Ready to shape the future of life sciences? Apply now.


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