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Validation Engineer I

Company: Thorne
Location: Summerville
Posted on: June 7, 2021

Job Description:

Validation Engineer I

We are looking for top of market talent to help grow and innovate our company. If you are someone who embraces challenge, fosters innovation, and desires to make a difference in the world, then let's talk.

At Thorne we make products that matter - ones that make people's lives better. Each day begins with a mission to help others discover and achieve their best health. We count on our team members to challenge and push the boundaries to make that happen. As a self-motivated Validation Engineer I you'll be joining a team of more than 350 passionate individuals committed to our cause of providing superior health solutions.

A day in the life of a Validation Engineer I at Thorne requires:

General Responsibilities:

  • Being knowledgeable of current FDA guidelines and industry standards pertaining to cleaning validation.

Equipment Qualification and Process Validation:

  • Assisting in the identification of critical quality parameters and processing attributes for new equipment or facility modifications.
  • Assisting in the development and review of User Requirements Specifications (URS).
  • Facilitating formal quality risk assessments. Suggesting design modifications to address risks and designing in quality and safety.
  • Developing commissioning strategies based on the URS and Risk Assessment to verify equipment design while minimizing project cost and schedule impact (risk-based approach).
  • Developing, writing, and executing protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Supporting periodic review of manufacturing systems to ensure that equipment remain in a qualified state and that processes remain in a validated state.
  • Being responsible for all aspects of Process Validation including providing process risk assessments and authoring, writing, and reviewing validation protocols and reports.
  • Leading Continuous Process Verification activities to assure processes remain in a validated state.

Cleaning Validation:

  • Being responsible for all aspects of Cleaning Validation from start to finish, including establishing, managing, and maintaining a scientifically sound cleaning validation program.
  • Writing, reviewing and/or revising site Cleaning Validation Master Plan.
  • Performing sampling for cleaning studies and/or continuous monitoring/verification activities, including the collection of rinse water sampling and surface swab sampling and the submission of samples to QC lab for testing.
  • Coordinating and scheduling cleaning validation and/or continuous monitoring/verification activities with appropriate departments.
  • Assisting in the investigation of deviations encountered during the execution of validation and/or continuous monitoring/verification activities and provide documentation to support the findings of the investigation.
  • Evaluating cleaning procedures and revising with process improvements as necessary.
  • Training other personnel on rinse sampling and surface swab sampling.
  • Writing, reviewing and executing cleaning validation protocols for product manufacturing and support processes, including analysis and review of test data results.
  • Being responsible for summarizing results and conclusions when writing final reports.
  • Ensuring final reports and study data is reviewed and approved in a timely manner after execution is completed.
  • Developing clean/dirty hold times.
  • Helping with various validation projects as assigned by the Engineering Manager.
  • Being responsible for the Qualification program. Individually being accountable for timely qualification deliverables on key projects (construction / process equipment / processes).
  • Acting as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout.

Employment is contingent on satisfactory results from a drug screening, background and reference checks, and a physical examination.

What You Need:

  • Bachelor's Degree (or equivalent) in applicable process and equipment engineering field, with documented combination of education and experience readily available.
  • 1-3 years' experience in an FDA-regulated environment and/or in a manufacturing facility with a cGMP environment preferred.

What We Offer:

At Thorne, we offer employees the chance to work with great people on exciting projects, with opportunity for growth. We also provide a full range of benefits for you and your eligible family members, such as:

  • Competitive compensation
  • 100% company-paid medical, dental, and vision insurance coverage
  • Company-paid short- and long-term disability insurance
  • Company- paid life insurance
  • 401k plan with employer matching contributions up to 4%
  • Gym membership reimbursement
  • Monthly allowance of Thorne supplements
  • Paid time off, volunteer time off and holiday leave
  • Training, professional development, and career growth opportunities
  • A safe and clean work environment

A little bit more about us.

We are committed to providing personalized health solutions, cutting-edge home health test technology, and superior supplements. To do that, Thorne owns every step of its business, from R&D 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 to 30 to 40-year-olds.
  • The #2 most dispensed supplement brand.
  • The fastest growing supplement company with sales on Amazon; the #1 practitioner brand; with an average ranking of 4.42 of 5 stars.

If you want to make a difference in the lives of others consider becoming part of the Thorne team.

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER

Keywords: Thorne, Summerville , Validation Engineer I, Other , Summerville, South Carolina

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