Validation Engineer Job

Validation Engineer is needed to perform the following duties:

· Responsible for all respects of validation processes like- documenting commissioning activities, establishing the process and developing and performing qualification studies to provide a high degree of assurance that equipment and processes will consistently produce a drug product meeting its pre-determined specifications along with quality attributes.

· Generate various technical documents such as protocols for method validation, Standard operating procedures (SOP’s), Specifications and reports.

· Generate change control, CAPA, and perform investigation for process deviations.

· Lead engineering support to evaluate, mitigate, re-validate, and maintain compliance of the group’s products such as Impella pumps and controllers and their installation Qualifications, Operational Qualification and Performance Qualifications.

· Participate as an integral member of cross-functional engineering team consisting of Product & Manufacturing Engineering and contributing ideas as well as designing, managing, or executing, and interpreting device development activities. Also, part of Validation Review Board for Device Validations.

· Manages routine small projects without assistance. Process Monitoring for validated process within the plant. Following up with lab test results and addressing concerns.

· Perform gap analysis and Root Cause Analysis of the group’s portfolio of products and technical files with respect to the new nonconformances. Improve inspection methods using SPC such as Gage R&R, Anova, Process capability studies.

· Responsible for performing capability studies, cleaning method studies, Raw material and packaging material testing and reviewing supplier quality validations.

· Collaborate with Metrology for gage development, calibrations for efficacy of inspection within and outside the process.

· Maintain and update device history files of medical devices and control plans..

· Write, execute and review complex protocols and coordinate validation activities from other departments.

· Train other validation personnel.

Bachelor's Degree is required in Mechanical Engineering or Engineering Management .

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave