Validation Engineer I
Posted on: June 7, 2021
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
- 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
- Assisting in the development and review of User Requirements
- Facilitating formal quality risk assessments. Suggesting design
modifications to address risks and designing in quality and
- 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
- 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.
- 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
- 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
- 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
- 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
- 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
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
- 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
- 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
- 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
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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