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Quality Assurance Validation Engineer

2 months ago

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

At Thorne Research Inc, we are dedicated to creating impactful products that enhance health and well-being. Our mission is to empower individuals to reach their optimal health through innovative solutions. We rely on our dedicated team members to challenge norms and drive progress in our industry.

POSITION SUMMARY: The Validation Engineer II plays a crucial role in supporting the commissioning and qualification processes associated with cGMP equipment acquisition, installation, operation, and modifications within our facilities. This position is responsible for leading verification efforts in accordance with the Thorne Cleaning/Validation Master Plan, ensuring that all cGMP equipment is properly installed and maintained in a qualified condition. The Validation Engineer II collaborates closely with Engineering management, Engineering Staff (including Engineers and Technicians), Quality Assurance, and Equipment System Owners to formulate and oversee the validation strategy for all equipment and processes.

KEY RESPONSIBILITIES: The following responsibilities are essential to this role:

  • Oversee and supervise validation activities, including observing production personnel during cleaning processes and monitoring relevant parameters.
  • Develop and deliver training on Standard Operating Procedures (SOPs) related to validation processes.
  • Maintain knowledge of current regulatory standards and industry practices concerning cleaning validation.
  • Assist in the preparation of regulatory documents for submission to governing agencies.
  • Engage with regulatory authorities on validation compliance matters under the guidance of Thorne Quality.
  • Contribute to 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 modifications.
  • Support the development and review 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, document, and execute protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Conduct periodic reviews of manufacturing systems to ensure ongoing qualification and validation status.
  • Assist in all aspects of Process Validation, including risk assessments and the preparation of validation protocols and reports.
  • Lead Continuous Process Verification initiatives to ensure processes remain validated.

Cleaning Validation:

  • Manage all aspects 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 necessary.
  • 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.
  • Ensure timely review and approval of final reports and study data.
  • Establish clean/dirty hold times.

Qualifications:

Education and Experience - A Bachelor's degree in an applicable engineering or scientific discipline is required, along with a documented combination of education and hands-on experience in process development, production support, or manufacturing engineering within an FDA-regulated environment.

What We Offer:

Thorne Research Inc provides employees with the opportunity to work on innovative projects alongside talented individuals, with ample opportunities for professional growth. We offer a comprehensive benefits package, including:

  • Competitive salary
  • 100% company-paid medical, dental, and vision insurance
  • Company-paid short- and long-term disability insurance
  • Company-paid life insurance
  • 401k plan with employer matching contributions
  • Gym membership reimbursement
  • Monthly allowance for Thorne supplements
  • Paid time off, volunteer time off, and holiday leave
  • Training, professional development, and career advancement opportunities
  • A safe and clean work environment

About Us:

Thorne Research Inc is committed to delivering personalized health solutions, advanced home health testing technology, and high-quality supplements. We manage every aspect of our business, from research and development to product delivery and customer service. Currently, we are:

  • The only company with exclusive partnerships with the Mayo Clinic and U.S. Olympic teams.
  • The #1 prescribed practitioner brand for individuals aged 30 to 40.
  • The #2 most dispensed supplement brand.
  • The fastest-growing supplement company on Amazon, with an average rating of 4.42 out of 5 stars.

Join us in making a difference in the lives of others.

Note: Must be able to safely work with ingredients and products that may be derived from allergenic sources, including but not limited to nuts, soy, dairy, fish, and shellfish.

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER