Engineer Validation

3 weeks ago

Carlsbad, United States ICONMA Full time
  • Responsible for creating and implementing the Client Division validation program.
  • Creates and maintains validation documentation for new and existing systems and processes subject to design control.
  • Ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to requirements and standards as listed in the current Quality Systems Manual.
  • Represent Client Division during internal and external audits of validation projects and documentation.
  • Write validation documentation against production processes and systems in compliance to internal and external requirements utilizing well developed technical and regulatory skills.
  • Manage the execution of validation protocols, as protocol directors, in assurance of timely and cost-efficient completion through specialized experience and training.
  • Evaluate validation results of validation protocol executions employing specialized experience and training.
  • Consult with owner/user groups to summarize validation results in final reports incorporating strong communication skills and experience.
  • Manage Validation Master Plans (VMPs) and associated reports related to new product development and existing production processes, systems, and controls.
  • Perform validation assessment on Change Management documentation including, but not limited to document changes, system changes, and process changes.
  • Track and report validation progress of corporate validation projects through departmental project tracking tools.
  • Cultivates a wide range of internal networks and begins to develop an extensive external network of resources to facilitate completion of tasks.
  • May lead a project team of moderate scope.
  • Provides guidance to less experienced staff.
  • Acts as a mentor to lower-level individual contributors.
  • Influence exerted at peer level and occasionally at first levels of management.
  • Plans, organizes, and prioritizes own daily work routine to meet established schedule.
  • Exercises authority and judgment within defined limits to determine appropriate action.
  • Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.

  • Lead Validation Engineer

    2 weeks ago

    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...

  • Senior Validation Engineer

    5 days ago

    Carlsbad, United States Bolt Medical Full time

    About Bolt MedicalBolt 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 SummaryWe are seeking a Senior Validation Engineer to play a...

  • Senior Validation Engineer

    3 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...

  • Senior Validation Engineer

    3 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 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...

  • Senior Validation Engineer

    3 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 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...

  • Quality Assurance Validation Engineer

    2 weeks ago

    Carlsbad, United States Alphatec Spine Full time

    OverviewAs a Validation Engineer specializing in AIX, you will play a crucial role in the Validation Engineering process for both New Product Development and Sustaining Engineering, particularly focusing on software systems. You will collaborate closely with various teams including Quality Engineering, Research & Development, Marketing, and Product...

  • Engineer Validation

    3 weeks ago

    Carlsbad, United States ICONMA Full time

    Responsible for creating and implementing the Client Division validation program. Creates and maintains validation documentation for new and existing systems and processes subject to design control. Ensures that validation activities are implemented for systems and processes used to manufacture, control and store intermediates and finished products to...

  • Principal Validation Specialist

    2 weeks ago

    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...

  • Quality Assurance Validation Specialist

    2 weeks ago

    Carlsbad, United States Alphatec Spine Full time

    OverviewAs a Validation Engineer at Alphatec Spine, you will play a crucial role in the Validation Engineering process for both New Product Development and Sustaining Engineering, with a particular emphasis on software systems. You will collaborate closely with various teams including Quality Engineering, Research & Development, Marketing, and Product...

  • Engineer III, Manufacturing Process Engineer

    4 weeks ago

    Carlsbad, United States Thermo Fisher Scientific Full time

    Develop, optimize, and improve manufacturing processes to enhance efficiency, productivity, and quality. Conduct process validation studies, analyze data, and implement corrective actions to ensure process stability and compliance with regulatory st Process Engineer, Engineer, Manufacturing, Process

  • Quality Engineer

    2 weeks ago

    Carlsbad, United States Surf Search Full time

    Join our cardiovascular EP client's rapidly growing team and help as they embark on an exciting phase of their development! The company is eager to find a talented Quality Engineer to facilitate quality activities. This person will provide engineering support to new product development teams and/or sustaining manufacturing/operation teams. This role...

  • Quality Assurance Engineer, AIX

    2 weeks ago

    Carlsbad, United States Alphatec Spine Full time

    Validation Engineering for Innovative Product DevelopmentAlphatec Spine, Inc. is in search of a Validation Engineer to contribute to software systems for innovative product development and ongoing engineering efforts. The successful candidate will work collaboratively with multiple teams to ensure adherence to industry standards and regulations.Core...

  • Quality Assurance Engineer, AIX

    2 weeks ago

    Carlsbad, United States Alphatec Spine Full time

    Validation Engineering for Innovative Product DevelopmentAlphatec Spine, Inc. is in search of a Validation Engineer to contribute to the development of software systems for innovative product initiatives and ongoing engineering support. The successful candidate will engage with multiple teams to guarantee adherence to industry standards and...

  • Quality Engineer

    2 weeks ago

    Carlsbad, United States Surf Search Full time

    Join our cardiovascular electrophysiology client's rapidly growing team and help as they embark on an exciting phase of their development! The company is eager to find a talented Quality Engineer to facilitate quality activities. This person will provide engineering support to new product development teams and/or sustaining manufacturing/operation teams....

  • Quality Engineer

    2 weeks ago

    Carlsbad, United States Surf Search Full time

    Join our cardiovascular electrophysiology client's rapidly growing team and help as they embark on an exciting phase of their development! The company is eager to find a talented Quality Engineer to facilitate quality activities. This person will provide engineering support to new product development teams and/or sustaining manufacturing/operation teams....

  • Quality Assurance Engineer, AIX

    2 weeks ago

    Carlsbad, United States Alphatec Spine Full time

    Validation Engineering for Innovative Product DevelopmentAlphatec Spine, Inc. is on the lookout for a Validation Engineer to contribute to the development of software systems aimed at new product innovation and ongoing engineering support. The successful candidate will work closely with diverse teams to guarantee adherence to industry standards and...

  • Facilities Engineer

    4 days ago

    Carlsbad, United States PSC Biotech Full time

    About the RoleWe are seeking a highly skilled Facilities Engineer to join our team at PSC Biotech. As a key member of our site operations team, you will be responsible for ensuring the smooth integration of new systems into our existing infrastructure and supporting various engineering activities.Key ResponsibilitiesSystem Onboarding: Onboard systems into...

  • Project Engineer

    2 months ago

    Carlsbad, United States Mackinnon & Partners Full time

    Project Engineers are responsible for planning, coordinating, and executing engineering projects, ensuring quality, schedule, and cost targets are met. They play a key role in project design, documentation, and technical support.Key ResponsibilitiesProject Planning and Execution: Develop project plans, manage timelines and budgets, and mitigate risks.Design...

  • Project Engineer

    1 month ago

    Carlsbad, United States Mackinnon & Partners Full time

    Project Engineers are responsible for planning, coordinating, and executing engineering projects, ensuring quality, schedule, and cost targets are met. They play a key role in project design, documentation, and technical support.Key ResponsibilitiesProject Planning and Execution: Develop project plans, manage timelines and budgets, and mitigate risks.Design...

  • Biopharmaceutical Commissioning and Qualification Engineer

    3 days ago

    Carlsbad, United States MMR Consulting Full time

    Job SummaryWe are seeking a highly skilled Biopharmaceutical Commissioning and Qualification Engineer to join our team at MMR Consulting. As a key member of our engineering team, you will be responsible for leading the commissioning, qualification, and start-up of various equipment and facilities in the biopharmaceutical industry.Key ResponsibilitiesProvide...