Validation Engineer

Description Overview

The Validation Engineer performs equipment, process & cleaning validation within the Perrigo-New York facility.

Scope of the Role

Responsibilities; Performance of Equipment Qualification Studies:
•    Perform IQ/OQ/PQ on packaging equipment and manufacturing equipment, including tube filling machines, liquid filling machines, cartoner, labelers, checkweigher, collators, bundlers, kettles, agitators, propeller mixers, various pumps and control panels.
•    Perform Process Performance Qualification (PPQ) studies for new/reformulated products as well as to support process changes.
•    Perform Cleaning Validation (CV) studies for new/reformulated products as well as to support process changes.
•    Inspect production processes and prepare protocols and summary reports for packaging equipment and manufacturing equipment, CV, or PPQ studies.
•    Prepare, maintain, or review validation and compliance documentation, such as engineering change notices, schematics, or protocols.
•    Perform equipment validation, recommend and work with quality assurance to implement procedures to resolve production issues.
•    Provide assistance to operations personnel in the development of SOPs as needed.
•    Write and/or review summary reports for the various equipment qualification, CV and PPQ studies performed.
•    Prepare and execute protocols for temperature mapping studies.
•    Attend F.A.T. testing at vendor facility and create a protocol as per the equipment design.
•    Address problems related to production, equipment, safety and quality.
•    Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
•    Develop and review validation master plans, process flow diagrams, test cases, or standard operating procedures.
•    Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
•    Work with other departments regarding deviations, out of tolerance conditions and equipment issues observed during validation by conducting failure analysis, determining the root cause and taking corrective actions.

Accountabilities:

•    Performance of equipment IQ/OQ/PQ, CV and PPQ studies.

Experience Required

• Bachelor’s Degree in Mechanical/Chemical Engineering or relevant STEM field combined with 2 years’ experience in validation, laboratory, or operations within the pharmaceutical or a closely related industry.
• Good oral/written communication skills and interpersonal skills are required.
• Must be able to communicate effectively with all levels within the organization and keep management informed of any critical issues resulting from any of his/her responsibilities.
• This position requires the candidate to participate in both internal and external audits.
• Computer literacy is required. Some travel is required.
• Must be able to lift 50 lbs., bend, stretch, stand for extended periods of time, climb stairs, reach, twist, sit, walk, and/or run.
   

Salary Range: $85,000 to $105,000