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Senior Validation Engineer

5 months ago

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 JOB

As 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 documenting that processes, systems, and equipment meet regulatory and quality standards. This position requires a seasoned professional with a deep understanding of validation principles, excellent problem-solving skills, and the ability to collaborate across cross-functional teams.


ESSENTIAL DUTIES AND RESPONSIBILITIES

  • Develop and implement comprehensive validation strategies for processes, systems, and equipment.
  • Ensure alignment of validation activities with regulatory requirements and industry best practices.
  • Create and execute validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Performs Process Characterization (PC) and Test Method Validations (TMV)
  • Establish and maintain a centralized repository of validation documentation. (PFMEA, MVP, MVR)
  • Oversee the validation of complex manufacturing processes and cleaning procedures, ensuring a high level of scrutiny and adherence to quality standards.
  • Utilize data analysis to drive continuous improvement initiatives within validated processes.
  • Conduct risk assessments to identify critical validation requirements and areas of potential impact.
  • Collaborate with cross-functional teams to implement risk mitigation strategies.
  • Lead equipment qualification activities, ensuring that manufacturing equipment meets specified requirements.
  • Collaborate with equipment vendors to validate new or upgraded equipment.
  • Coordinate and conduct validation testing, including the execution of test scripts and the collection of data.
  • Analyze test results and ensure deviations are appropriately documented and addressed.
  • Utilize statistical methodologies to analyze validation data, ensuring robust conclusions and effective decision-making.
  • Implement statistical tools and techniques to enhance the reliability and efficiency of validation processes.
  • Provide training to junior validation engineers and other relevant personnel.
  • Act as a subject matter expert and mentor team members on validation best practices.


REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:

  • Bachelor's degree in Engineering or a related field. Master's degree is a plus.
  • 7+ years of experience in validation within a regulated industry (Pharmaceutical, Medical Devices)
  • Catheter Manufacturing is a plus
  • In-depth knowledge of validation principles, methodologies, and regulatory requirements (FDA, ISO, etc.)
  • Manufacturing or sustaining experience.


KNOWLEDGE, SKILLS AND ABILITIES:

  • Strong experience in developing and executing validation protocols.
  • Proficiency in risk assessment and mitigation strategies.
  • Excellent analytical and problem-solving skills. (Black Belt is a plus)
  • Exceptional communication skills, with the ability to collaborate effectively across teams.
  • Continual improvement process experience.
  • Demonstration of excellent organizational skills with the ability to adapt to a rapidly changing environment.