Job Title —Quality Engineer

Company —Vastek Inc.

Location —San Diego, California.

Job Description:

  • • Lead validation projects and complete all associated project documentation in line with regulatory expectations.
  • • Support validation projects as needed.
  • • Manage, coordinate and guide the execution of the site validation master plan.
  • • Provide the relevant support for regulatory audits, submissions and other auditor requests.
  • • Populate validation protocols (this requires gaining an in-depth knowledge of the product to be able to determine what the necessary output is and if it is meeting predefined criteria)
  • • Develop and run test protocols.
  • • Ensure projects are managed in conjunction with all regulatory requirements such as health & safety, cGMP, construction, environmental, etc.
  • • Develop and write commissioning, qualification and validation documents following established standards and templates.
  • • Ensure the validation status of equipment and systems are in compliance with cGMPs at all times.
  • • Manage validation documentation, commissioning test scripts, qualification validation protocols, summary reports and risk assessments.
  • • Review design deliverables from engineering including drawings, datasheets, specifications and engineering lists.
  • • Maintain validation documentation through the validation lifecycle.
  • • Provide evidence of both internal and external regulatory compliance.
  • • Troubleshoot in the event of abnormal testing results.
  • • Troubleshoot issues identified by other staff members.
  • • Ensure accurate records of all validation activities.
  • Requires bachelor's degree in Mechanical Engineering or a closely related field.

    Send resume to and refer to job title to swapna@vastekgroup.com.


    Job Title —Analytical Chemist

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description:(VAStek Inc. has openings in San Diego, CA) Analytical Chemist: Perform analytical chemical analysis for the release of raw materials, intermediates, and small molecule API drug substances. Develop, validate, and transfer analytical methods for raw materials, intermediates, and APIs. Write technical reports to document analytical methods. Investigate and solve analytical technical issues in analytical development, chemical development, process support, and quality control. Conduct testing of analytical samples. Utilize general wet chemistry and chromatography (HPLC, UPLC, and GC). Will work in unanticipated locations.

    Requires Master’s in Chemistry, Pharmaceutical Sciences, or related and 1 year experience.

    Send resume to and refer to job title to swapna@vastekgroup.com.


    Job Title — Computer System Validation Analyst

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description:(VAStek Inc. has openings in San Diego, CA) Computer System Validation Analyst: Research, develop, and execute Installation, Operational, Performance Qualification, Requalification and Revalidation protocols for stand-alone computer systems (local servers and cloud based) and embedded computer systems in manufacturing equipment. Generate and maintain traceability matrices. Provide CSV authoring, review, and approval of validation documents developed by functional validation teams, ensuring the documentation meets regulatory requirements and quality standards. Collaborate with project stakeholders and the information systems team to define needs, achievable solutions, and justifications to system requirements. Draft and execute computer system validation documentation. Translate system requirement specifications into executable validation protocols. Provide support to executors of the protocols when needed. Write reports summarizing system validation. Will work in unanticipated locations.

    Requires Master's in Computer Science, Engineering (any field), or related and 1 year experience.

    Send resume to and refer to job title to swapna@vastekgroup.com.


    Job Title —Manufacturing Engineer

    Company —Vastek Inc.

    Location —San Diego, California.

    Job Description:(VAStek, Inc. has multiple openings in San Diego, CA) Manufacturing Engineer: Test and develop manufacturing process methods. Author and execute process Validation Protocols (IQs, OQs, PQs). Review Corrective Action and Preventive Action (CAPA). Conduct review of manufacturing, quality control, and packaging specifications as part of complaint investigation to ensure products were manufactured according to specifications. Prepare TMV (Test Method Validation) and deviation reports and Gage R&R analysis reports. Provide technical support to fabrication processes, troubleshoot existing assembly methods and design new cost effective and efficient production assembly plans. Will work in unanticipated locations.

    Requires Masters in Engineering (any field), or related.

    Send resume to and refer to job title to swapna@vastekgroup.com

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