Position
Validation Engineer (Lynchburg, VA)
Department:
Quality Assurance
Fleet Laboratories is seeking a Validation Engineer to perform the functions for validation of product and cleaning of in-house manufacturing and packaging systems. This includes IQ/OQ/PQ, process validation and cleaning validation. This person will develop company validation standards, and support quality programs such as change control, calibration and technical releases.
Accountabilities
- All company validation functions related to manufacturing, raw materials, packaging, testing, and distribution of our products and raw materials, including writing protocols and final reports, reviewing testing methods, and analysis of data.
- Moderate direct impact on profitability results from maintaining proper adherence to validation and stability guidelines.
WHAT YOU’LL DO
- Perform all company validation functions related to manufacturing, raw materials, packaging, testing, and distribution of our products and raw materials, including writing protocols and final reports, reviewing testing methods, and analysis of data.
- Moderate direct impact on profitability results from maintaining proper adherence to validation and stability guidelines.
- Develop and write validation policies, procedures, and protocols.
- Perform IQ/OQ/PQ, cleaning, and utilities validation. Work closely with Engineering on new equipment specifications and engineering changes as related to process and cleaning validation.
- Evaluate, identify, and develop current company validation and stability standards to meet global requirements and current industry standards.
- Supervise, coordinate, and provide QA oversight for assembling and issuing New Product Technical releases prior to initial release of product to the market.
- Supervise, coordinate, and provide QA oversight for the Fleet Laboratories calibration program.
- Supervise, coordinate, and provide QA oversight for line/ship tests.
- Supervise, coordinate, and provide QA oversight for the change control process at Fleet Laboratories.
- Provide technical support on process investigations, quality improvement and CAPA activities (corrective and preventive action).
- Participate in training and instruction of departmental supportive personnel and provide technical leadership to the department.
- Provide technical support to a variety of corporate and international programs.
- Perform other related duties as required.
- Provides oversight for the calibration program.
- Use considerable judgment skills to troubleshoot and rectify any problems in testing and processing of products while conforming to company standards for product quality.
- Perform FATs as needed and provide technical expertise for acceptance test on site
PHYSICAL REQUIREMENTS:
- Some travel required
QUALIFICATIONS:
- Associates of Science and/or BS degree in Math, Science, Engineering or related field
- Minimum of 10 years’ experience in pharmaceuticals or other GMP industry
- Minimum of 5 years’ experience in Validation and/or Technical Services
- Experience with equipment qualification is recommended
- Ability to travel by car, rail and air.
Prestige is an Equal Opportunity Employer
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