Position Title
Validation Engineer – Process Development & Validation
SBU
Medical
Department
Internal
Relocation Covered
Potential
Educational Requirements
Bachelor's degree
Experience Requirements
A minimum of 3 years experience in process validation, process engineering, or quality assurance engineering functions commensurate with the responsibilities outlined above.
Strong process and statistical background
Knowledge of ASQ< ANSI< AAMI and ASTM standards and guidance documents
Knowledge of sampling plans, inspection criteria and techniques, critical attributes, process validations, statistical methods, disposition of non-conforming product, trending methods, environmental monitoring.
Knowledge and experience with statistical process control, defects-per-million, and other process monitoring methods and techniques.
Strong communication, organizational and time management skills.
Ability to write clear and concise technical reports.
Familiarity with medical device processes and documentation.
Process area specialist must have good communication ability to be the validation ambassador of similar processes across multiple manufacturing plants as well as perform non specialized validation activities.
Qualification Requirements
BS – Engineering discipline or Professional Engineer (PE) certification
Preferred Qualifications
n/a
Responsibilities
Support Process validation activities at the plant and inter-plant levels to ensure regulatory compliance and effectiveness of facilities, equipment, and processes.
1. Provide technical expertise and guidance to Plant manufacturing on the subject of process validation. 2. Understand, implement and utilize risk-based validation system. Provide input for ongoing improvements to the system. 3. Support other engineers and technicians in areas of expertise. 4. Support continuous improvement activities for the validation program to ensure efficiency, effectiveness, and compliance. Initiate corrective action as necessary. 5. Execute activities as specified in Validation Master Plans and project plans and maintain project schedules. 6. Lead manufacturing process validations, test method validations, process capability studies, and process improvements. 7. Select and utilize a wide range of appropriate statistical methodologies and techniques. 8. Establish inspection criteria for new and modified products. 9. Perform engineering studies on new and existing manufacturing processes to properly document process input to output relationships. These studies include the use of design of experiments (DOE) and the identification of critical variables.
10. Ensure that quality system inputs to the validation system are adequately addressed at the plant level. These inputs include undesirable trends or incidents of customer complaints, non-conforming materials, and vendor quality problems. 11. Provide input to and utilize risk management analyses including hazard analyses, design and process FMEAs, and issue/event-based risk assessments. Ensure their compliance with Teleflex policies and procedures. 12. Participate in formal supplier quality evaluations; conduct supplier and internal quality audits relative to process control and process validation as requested. 13. Perform test method validation activities including equipment parameter studies and gage repeatability and reproducibility studies. 14. Coordinate facility and maintenance activities to facilitate improvements and repairs impacting validation activities. 15. Review and, as appropriate, modify quality system documentation to ensure compliance and effectiveness. 16. Defend personal qualifications and work output during FDA and customer audits. 17. Adhere to and ensure the compliance of Teleflex’s Code of Ethics, all Company policies, rules, procedures and housekeeping standards.
