VALIDATION ENGINEER II

Job Description

Job Description

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. At Thorne, you’ll be joining a team of more than 550 passionate individuals committed to our cause of providing superior health solutions.

POSITION SUMMARY : The Validation Engineer II supports commissioning and qualification activities associated with cGMP equipment acquisition, installation, operation, and facility modification.

The Validation Engineer II will lead verification activities in alignment with Thorne Cleaning / Validation Master Plan to ensure that all cGMP equipment is installed and maintained in a qualified state.

The Validation Engineer II works in partnership with the Engineering management, Engineering Staff (Engineers and Technicians), Quality Assurance, and Equipment System Owners to develop and oversee the commissioning and qualification and validation strategy for all equipment and processes.

RESPONSIBILITIES Satisfactorily performing and / or achieving the following Responsibilities are essential duties of the job.

• Supports or responsible for overall supervision and oversight during execution of validation activities (for example observation of production personnel performing cleaning process and the monitoring and recording of observed values concurrent with cleaning event).
• Writes and provides training on SOPs relevant to validation procedures.
• Knowledgeable of current regulatory guidelines and industry standards pertaining to cleaning validation.
• Assists in writing regulatory documents for regulatory agency submission.
• Under the guidance of Thorne Quality, interacts with regulatory authorities regarding validation compliance issues and regulatory requirements.

Perform other qualification and validation activities as assigned by the Engineering Manager or Validation Manager.

• Works on other Validation Engineering projects as assigned by Manager.
• Equipment Qualification and Process Validation :
• Assists in the identification of critical quality parameters and process attributes for new equipment or facility modifications.
• Assists in the development and review of User Requirements Specifications (URS).
• Facilitates formal quality risk assessments. Suggests design modifications to address risks and design in quality and safety.
• Assists in developing commissioning strategies based on the URS and Risk Assessment to verify equipment design while minimizing project cost and schedule impact (risk-based approach).
• Develops, writes, and executes protocols for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Supports periodic review of manufacturing systems to ensure that equipment remains in a qualified state and that processes remain in a validated state.
• Assists in all aspects of Process Validation including providing process risk assessments and authoring, writing, and reviewing validation protocols and reports.
• Leads Continuous Process Verification activities to assure processes remain in a validated state.

Cleaning Validation :

• Assists with all aspects of Cleaning Validation from start to finish, including establishing, managing, and maintaining a scientifically sound cleaning validation program.
• Writes, reviews and / or revises site Cleaning Validation Master Plan.
• Performs 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.
• Coordinates and schedules cleaning validation and / or continuous monitoring / verification activities with appropriate departments.
• Assists 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.
• Evaluates cleaning procedures and revises with process improvements as necessary.
• Trains other personnel on rinse sampling and surface swab sampling.
• Writes, reviews, and executes cleaning validation protocols for product manufacturing and support processes, including analysis and review of test data results.
• Assists in summarizing results and conclusions when writing final reports.
• Ensures final reports and study data is reviewed and approved in a timely manner after execution is completed.
• Develops clean / dirty hold times.

What You Need :

Education and / or Experience - Bachelor’s degree in an applicable engineering or scientific field, with documented combination of education and experience readily available.

3 - 7 years’ hands-on experience in process development, production support, manufacturing engineering, or another relevant field in an FDA regulated environment is required.

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.

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

THORNE IS AN EQUAL OPPORTUNITY EMPLOYER