Senior Validation Engineer
2 months ago
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 ExecutionCreate 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 ValidationPerform Process Characterization (PC) and Test Method Validations (TMV) to ensure that processes and test methods are validated and meet regulatory requirements.
Documentation and Record KeepingEstablish 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 CommunicationCollaborate with cross-functional teams, including manufacturing, quality, and regulatory, to ensure that validation activities are aligned with business objectives and regulatory requirements.
Continuous ImprovementUtilize 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 SkillsIn-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.
-
Senior Validation Engineer
5 months ago
Carlsbad, United States Bolt Medical Full timeDIRECT 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...
-
Lead Validation Engineer
2 months ago
Carlsbad, United States Bolt Medical Full timeLead 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 timeAbout 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 timeh3About 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,...
-
Senior Mechanical Engineer P3
1 month ago
Carlsbad, United States RTX Full timeJob 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...
-
Senior Manufacturing Engineer
10 hours ago
Carlsbad, United States People With Chemistry Full timeA 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...
-
Principal Validation Specialist
2 months ago
Carlsbad, United States Bolt Medical Full timePrincipal 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...
-
Senior Software Quality Assurance Engineer
4 weeks ago
Carlsbad, United States Bolt Medical Full timeJob 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...
-
Senior Manufacturing Quality Control Engineer
4 weeks ago
Carlsbad, United States American Lithium Energy Corporation Full timeRole 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...
-
Senior Manufacturing Quality Control Engineer
4 weeks ago
Carlsbad, United States American Lithium Energy Corporation Full timeRole 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...
-
Senior Manufacturing Quality Control Engineer
4 weeks ago
Carlsbad, United States American Lithium Energy Corporation Full timeRole 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...
-
Senior Manufacturing Quality Control Engineer
4 weeks ago
Carlsbad, United States American Lithium Energy Corporation Full timeRole 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...
-
Senior Control Engineer
1 month ago
Carlsbad, New Mexico, United States Talent Consulting Experts Full timeJob 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...
-
Senior Software Engineer
7 days ago
Carlsbad, United States KBR Full timeJob 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...
-
Senior Manager, Electrical Engineering
4 weeks ago
Carlsbad, United States Jobot Full timeDice 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...
-
Senior Civil Engineer Position
2 weeks ago
Carlsbad, United States GEI Consultants Full timeAbout 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...
-
Senior Product Development Engineer
1 month ago
Carlsbad, United States Gilero Full timeJob 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...
-
Senior Electrical Design Engineer
2 weeks ago
Carlsbad, United States Collabera Full timeJob 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...
-
Senior Fluidics Engineer
2 weeks ago
Carlsbad, United States Roche Holdings Inc. Full timeAbout 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...
-
Senior Water Resources Engineer
2 months ago
Carlsbad, United States Assystem Full timeJob 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...