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Validation Engineer

Department:  Americas R&D
Location: 

Usa

Job ID: 

Job Purpose/Overview

At Lavazza, the Validation Engineers plan, create, and execute tests that check if a company’s manufacturing equipment produces products that meet performance, quality, and industry-specific safety standards. Their understanding of manufacturing processes and data analysis helps them prevent and fix issues, working with management to improve the company’s manufacturing processes.

 

The candidate will be accountable primarily for developing protocols and working with Manufacturing Engineering group to execute IOQ / PQ activities. These activities are related to periodic re-validations, new projects, and new product introductions (Tech Transfers). Responsibilities include designing experiments/studies, authoring protocols (e.g., engineering runs; IOQ/PQ), reviewing complex data, and authoring validation reports.

 

Location: West Chester, PA
 

 

Key Responsibilities

 

•    Develops and executes Validation and Qualification Protocols for process equipment, automated equipment/systems, and utilities with minimal supervision.
•    Authors Validation and Qualification Reports summarizing the results of protocol field execution activities with minimal supervision.
•    Supports troubleshooting of equipment/system including authoring exceptional conditions as a response to unsuccessful validation testing.
•    Interface with staff in Manufacturing Operations, Technical Services, Project Engineering, Research and Development and Quality Assurance, as well as others, to coordinate resources/materials and complete validation activities in a timely manner.
•    Maintains validation for lab equipment and instrumentation in accordance with company policy requirements.
•    Writes investigation reports and updates procedures with minimal supervision. 

 

 

Job Specifications/Qualifications

 

•    Four year college degree from an accredited institution, Engineering/Physical Science/Food Science
•    Advanced degree in Engineering / Business discipline preferred
•    3-5 years of professional experience working in validation role within the food, pharamaceutical or medical device industry.
•    Candidates from contract manufacturing/OEM background have proven to be successful.
•    Working knowledge of IQ, OQ, PQs, FAT, SAT.
•    Good communication skills, both written and verbal, as this person will be working directly with customers.
•    Ability to develop and execute technical writing/protocols.
•    Familiarity with current workplace equipment safety standards
•    Experience working as part of a team and with external suppliers.
•    Able to leverage interpersonal skills to form strong relationships / build networks.
•    Knowledge of 21 CFR Part 11 and ISPE GAMP5 is required.
•    Knowledge of GLP and cGMP is required.
•    Ability to work with computer equipment and software to accomplish the described duties (Microsoft Word, Excel, Outlook, and Access).
•    Ability to accurately perform arithmetic, algebraic and geometric calculations.

 

 


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