Validation Engineer Job

Validation Engineer is needed to perform the following duties:

· Author and review Standard Operating Procedures, and specifications for tablet manufacturing equipment.

·Perform visual inspection of finished products o make sure the products are free from foreign particles and meet the acceptance criteria of the products.

·Ensure sampling has been performed as per protocol requirements.

·Assure that validation activities are carried out within the regulatory requirements in terms of validation, operating procedures, and training to assigned personnel.

· Analyzing the manufacturing processes and critical quality attributes performance though Continued Process Verification (CPV) through statistical Software JMP.

· Statistical analysis of product performance.

·Periodic review of Corrective and Preventive Actions (CAPAs), Deviations and Change Controls of Active Pharmaceutical Ingredients (APIs), excipients, intermediate and Finished Products to check the product robustness over time.

· Timely monitoring the product performance using control charts and Lean Six Sigma methods.

· Ability for interpretation of data generated by various developmental analytical tests including Dissolution, Blend Uniformity, Assay, HPLC, Particle size, Spectroscopy, etc.

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

· Train other QA personnel.

· To ensure complaint handling and investigation with appropriate measures taken to prevent reoccurrence.

· Calculate Process Performance Index (Ppk), Process Capability Index (Cpk), Standard Deviation, % Reconciliation and % Yield using JMP software.

·Prepare and review Pre Approval Inspection (PAI) reports for new and transfer products according to FDA regulations.

·Review Work Orders and Lot results using Laboratory Information Management System (LIMS).

·Ensure that all Changes are monitored through the Change Control system.

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

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