Validation Engineer

Engineering/Technical Operations Bronx, New York


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

(Bronx, NY) Utilize pharmaceutical manufacturing knowledge to 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.  Inspect production processes and prepare protocols and summary reports for packaging equipment and manufacturing equipment.  Prepare, maintain, and review validation and compliance documentation, such as engineering change notices, schematics, or protocols.  Draft and review summary reports for the various equipment qualification studies performed.  Conduct validation or qualification tests for 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.  Prepare and review protocols for process validation studies for new products, batch size scale-ups, product line extensions, and API supplier changes.  Monitor both compounding and packaging operations as necessary to ensure conformance with approved protocols and procedures during process validation studies.  Review/approve validation sampling records and QA physical testing results.  Review and analyze all data relating to process validation studies. Prepare and review process validation final reports.  Prepare and review protocols for cleaning validation studies.  Calculate and document equipment product contact surface areas to be used during cleaning validation studies.  Communicate with AR&D methods to be employed during cleaning validation studies.  Coordinate the timing of the cleaning and swab sampling activities with the appropriate Operations, QA and Laboratory personnel.  Monitor the cleaning/swab sampling operation to ensure conformance with approved protocols and procedures.  Review and analyze all documentation and data relating to cleaning validation studies.  Prepare and review cleaning validation final reports.

Minimum of a Master's degree in Pharmaceutical Manufacturing or Chemical Engineering and two years of validation engineering experience with cleaning validation studies in the pharmaceutical industry required.

Please apply online to Perrigo New York, Inc., a subsidiary of Perrigo Company, at www.perrigocareers.com.  Equal Opportunity Employer.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.