Senior Validation Engineer

2 months ago


Carlsbad, United States Bolt Medical Full time

About Bolt Medical

Bolt Medical is a leading medical device company dedicated to delivering innovative solutions that improve patient outcomes. We are committed to excellence in quality and regulatory compliance, and we are seeking a highly skilled Senior Validation Engineer to join our team.

Job Summary

We are seeking a Senior Validation Engineer to play a critical role in ensuring the quality and compliance of our products. As a Senior Validation Engineer, you will be responsible for developing and implementing robust validation strategies, verifying and documenting that processes, systems, and equipment meet regulatory and quality standards.

Key Responsibilities

  • Validation Strategy Development

Develop and implement comprehensive validation strategies for processes, systems, and equipment to ensure alignment with regulatory requirements and industry best practices.

Validation Protocol Execution

Create and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), to ensure that manufacturing equipment meets specified requirements.

Process Characterization and Test Method Validation

Perform Process Characterization (PC) and Test Method Validations (TMV) to ensure that processes and test methods are validated and meet regulatory requirements.

Documentation and Record Keeping

Establish and maintain a centralized repository of validation documentation, including PFMEA, MVP, and MVR, to ensure that all validation records are accurate and up-to-date.

Collaboration and Communication

Collaborate with cross-functional teams, including manufacturing, quality, and regulatory, to ensure that validation activities are aligned with business objectives and regulatory requirements.

Continuous Improvement

Utilize data analysis to drive continuous improvement initiatives within validated processes, and implement statistical tools and techniques to enhance the reliability and efficiency of validation processes.

Requirements

  • Education and Experience

Bachelor's degree in Engineering or a related field, with 7+ years of experience in validation within a regulated industry (Pharmaceutical, Medical Devices).

Knowledge and Skills

In-depth knowledge of validation principles, methodologies, and regulatory requirements (FDA, ISO, etc.), with excellent analytical and problem-solving skills, and exceptional communication skills.

What We Offer

Bolt Medical offers a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced Senior Validation Engineer looking for a new challenge, please submit your application.



  • Carlsbad, United States Bolt Medical Full time

    DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.SUMMARY OF THE JOBAs a Senior Validation Engineer, you will play a critical role in ensuring the quality and compliance of products by developing and implementing robust validation strategies. Your expertise will be essential in verifying and...


  • Carlsbad, United States Bolt Medical Full time

    Lead Validation EngineerBolt Medical is on the lookout for an experienced Lead Validation Engineer to enhance our dynamic team. The successful candidate will play a pivotal role in formulating and executing comprehensive validation plans to guarantee product excellence and adherence to regulatory standards. If you possess a profound knowledge of validation...

  • Validation Engineer

    1 week ago


    Carlsbad, United States PSC Biotech Full time

    About the RolePSC Biotech is seeking an experienced Validation Engineer to join our team. As a key member of our quality assurance team, you will be responsible for leading and executing validation activities for equipment commissioning, qualification, and validation of facilities and new product buildouts.You will collaborate with cross-functional teams to...

  • Validation Engineer

    7 days ago


    Carlsbad, California, United States PSC Biotech Full time

    h3About the Role/h3pPSC Biotech is seeking an experienced Validation Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and compliance in our operations./ph3Key Responsibilities/h3ulliLead and execute validation activities for equipment commissioning, qualification,...


  • Carlsbad, United States RTX Full time

    Job Title: Senior Mechanical Engineer P3At RTX, we are seeking a highly motivated and experienced Senior Mechanical Engineer P3 to join our team. As a key member of our engineering team, you will be responsible for designing, developing, and implementing mechanical systems and solutions that meet the needs of our customers.Key Responsibilities:Design and...


  • Carlsbad, United States People With Chemistry Full time

    A growing medical device company located in San Diego county is looking to hire a hands-on Senior Manufacturing Engineer for their process development and manufacturing department. The company is developing breakthrough technology and innovative electrophysiology devices to treat cardiovascular diseases. The Manufacturing team is growing to prepare for the...


  • Carlsbad, United States Bolt Medical Full time

    Principal Validation SpecialistBolt Medical is on the lookout for a talented Principal Validation Specialist to enhance our engineering team. The successful candidate will play a crucial role in crafting and executing comprehensive validation frameworks that uphold product excellence and regulatory adherence. If you possess a profound knowledge of validation...


  • Carlsbad, United States Bolt Medical Full time

    Job Title: Senior Software Quality EngineerBolt Medical is seeking a highly skilled Senior Software Quality Engineer to lead Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development projects and for automated data processing systems used as part of the quality system.Key...


  • Carlsbad, United States American Lithium Energy Corporation Full time

    Role Description•This is a full-time on-site role for a Senior Manufacturing Quality Control Engineer at the American Lithium Energy Corporation in Carlsbad, CA. The Senior Manufacturing Quality Control Engineer will be responsible for overseeing quality control processes, conducting inspections, identifying defects, and implementing corrective actions to...


  • Carlsbad, United States American Lithium Energy Corporation Full time

    Role Description• This is a full-time on-site role for a Senior Manufacturing Quality Control Engineer at the American Lithium Energy Corporation in Carlsbad, CA. The Senior Manufacturing Quality Control Engineer will be responsible for overseeing quality control processes, conducting inspections, identifying defects, and implementing corrective actions to...


  • Carlsbad, United States American Lithium Energy Corporation Full time

    Role Description•This is a full-time on-site role for a Senior Manufacturing Quality Control Engineer at the American Lithium Energy Corporation in Carlsbad, CA. The Senior Manufacturing Quality Control Engineer will be responsible for overseeing quality control processes, conducting inspections, identifying defects, and implementing corrective actions to...


  • Carlsbad, United States American Lithium Energy Corporation Full time

    Role Description• This is a full-time on-site role for a Senior Manufacturing Quality Control Engineer at the American Lithium Energy Corporation in Carlsbad, CA. The Senior Manufacturing Quality Control Engineer will be responsible for overseeing quality control processes, conducting inspections, identifying defects, and implementing corrective actions to...


  • Carlsbad, New Mexico, United States Talent Consulting Experts Full time

    Job Title: Senior Control EngineerWe are seeking a highly skilled Senior Control Engineer to join our team at Talent Consulting Experts. As a Senior Control Engineer, you will be responsible for designing, implementing, and supporting process control systems for our refined products and petrochemical pipelines.Key Responsibilities:Design and configure...


  • Carlsbad, United States KBR Full time

    Job Title: Senior Software EngineerJob Summary:KBR is seeking a skilled Senior Software Engineer to join our team in Carlsbad, CA. As a Senior Software Engineer, you will be responsible for designing, developing, and testing software applications for government and commercial customers. You will work individually or as part of a small team to develop...


  • Carlsbad, United States Jobot Full time

    Dice is the leading career destination​ for tech experts at every stage of their careers.  Our client, Jobot, is seeking the following.  Apply via Dice today!REMOTE opportunity (must live in and be licensed in California) Leading Life Science/Biotechnology AEC firm, looking for a Senior Manager or Director level candidate to oversee their engineering...


  • Carlsbad, United States GEI Consultants Full time

    About the RoleWe are seeking a highly skilled Senior Civil Engineer to join our team at GEI Consultants. As a Senior Civil Engineer, you will play a key role in leading field and engineering design efforts related to water resource and water conveyance facilities.Key ResponsibilitiesCollaborate with other senior level engineers to lead field and engineering...


  • Carlsbad, United States Gilero Full time

    Job SummaryWe are seeking a highly skilled Senior Product Development Engineer to lead our mission-driven team at Gilero. As a key member of our team, you will be responsible for overseeing the design, development, and production of medical devices and combination devices. Your expertise will be crucial in ensuring high-quality outcomes and seamless...


  • Carlsbad, United States Collabera Full time

    Job Title: Senior Electrical Design EngineerJob Summary: We are seeking a highly skilled Senior Electrical Design Engineer to join our team at Collabera. The ideal candidate will have experience in design and diagnostics of custom video interfaces driving waveguide displays using USB-C DisplayPort Alt Mode.Key Responsibilities:* Design and develop custom...


  • Carlsbad, United States Roche Holdings Inc. Full time

    About the RoleWe are seeking a highly skilled Senior Fluidics Engineer to join our team at Roche Holdings Inc. in Carlsbad, CA. As a key member of our R&D team, you will be responsible for providing technical direction and expertise in the implementation of electrowetting and microfluidics technology in IVD consumables and instrumentation.Key...


  • Carlsbad, United States Assystem Full time

    Job Title: Senior Hydraulic EngineerAssystem Stup is a leading design, engineering, and project delivery consultancy that combines expertise in low-carbon technologies and complex project management with extensive experience in urban and territorial infrastructures, civil engineering, and transportation systems.Job SummaryWe are seeking a highly skilled...