Quality Assurance Validation Engineer

2 months ago

Summerville, South Carolina, United States Thorne Research Inc Full time
Position Overview

At Thorne Research Inc, we are dedicated to enhancing the health and well-being of individuals through innovative products. Our team is comprised of over 550 committed professionals who strive to push the limits of health solutions.

ROLE SUMMARY: The Senior Validation Specialist plays a crucial role in supporting the commissioning and qualification processes related to cGMP equipment acquisition, installation, and operational modifications. This position is responsible for leading verification efforts in accordance with the Thorne Cleaning/Validation Master Plan, ensuring that all cGMP equipment is both installed and maintained in a qualified condition. Collaboration with Engineering management, Engineering Staff, Quality Assurance, and Equipment System Owners is essential to develop and manage the validation strategy for all equipment and processes.

KEY RESPONSIBILITIES: The following duties are fundamental to this role:

  • Oversee and supervise validation activities, including monitoring production personnel during cleaning processes and documenting observed values.
  • Draft and deliver training on Standard Operating Procedures (SOPs) related to validation practices.
  • Maintain knowledge of current regulatory standards and industry guidelines concerning cleaning validation.
  • Assist in the preparation of regulatory documents for submission to relevant authorities.
  • Engage with regulatory bodies on validation compliance issues under the guidance of Thorne Quality.
  • Participate in various Validation Engineering projects as assigned by management.
  • Equipment Qualification and Process Validation:
  • Identify critical quality parameters and process attributes for new equipment or facility changes.
  • Contribute to the development and assessment of User Requirements Specifications (URS).
  • Facilitate formal quality risk assessments and recommend design modifications to enhance quality and safety.
  • Develop commissioning strategies based on URS and Risk Assessments to validate equipment design while minimizing costs and schedule impacts.
  • Create, write, and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Conduct periodic reviews of manufacturing systems to ensure equipment remains qualified and processes validated.
  • Support all aspects of Process Validation, including risk assessments and authoring validation protocols and reports.
  • Lead Continuous Process Verification initiatives to ensure ongoing process validation.

Cleaning Validation:

  • Manage all phases of Cleaning Validation, establishing and maintaining a scientifically sound program.
  • Draft, review, and update the site Cleaning Validation Master Plan.
  • Conduct sampling for cleaning studies and continuous monitoring activities, including rinse water and surface swab sampling.
  • Coordinate cleaning validation activities with relevant departments.
  • Investigate deviations encountered during validation activities and document findings.
  • Evaluate cleaning procedures and implement process improvements as needed.
  • Train personnel on rinse and surface swab sampling techniques.
  • Draft, review, and execute cleaning validation protocols for manufacturing and support processes, including analysis of test data.
  • Summarize results and conclusions in final reports, ensuring timely review and approval.
  • Establish clean/dirty hold times.

Qualifications:

A Bachelor's degree in an applicable engineering or scientific discipline is required, along with relevant hands-on experience in process development, production support, or manufacturing engineering within an FDA-regulated environment.

Benefits:

Thorne Research Inc offers a comprehensive benefits package, including:

  • Competitive salary
  • Full medical, dental, and vision insurance coverage
  • Short- and long-term disability insurance
  • Life insurance
  • 401k plan with employer matching
  • Gym membership reimbursement
  • Monthly allowance for Thorne supplements
  • Paid time off and volunteer time off
  • Professional development and career growth opportunities
  • A safe and clean working environment

About Us:

Thorne Research Inc is committed to delivering personalized health solutions and superior supplements. We manage every aspect of our business, from research and development to product delivery and customer service. We pride ourselves on our exclusive partnerships and our standing as a leading brand in the supplement industry.

Thorne is an equal opportunity employer.

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