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.

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

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.
  • Inspect production processes and prepare protocols and summary reports for packaging equipment and manufacturing equipment.
  • 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 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.

 

Performance of Process Validation Studies:

  • Prepare and/or review protocols for process validation studies for new products, batch size scale-ups, product line extensions, API supplier changes, etc.
  • Prior to performance of process validation studies, review approved protocols with the appropriate Operations and QA/QC personnel.
  • During process validation studies, monitor both compounding and packaging operations as necessary to ensure conformance with approved protocols and procedures. Review/approve validation sampling records and QA physical testing results.
  • Review and analyze all documentation and data relating to process validation studies.
  • Prepare and/or review process validation final reports.

 

Performance of Cleaning Validation Studies:

  • Prepare and/or 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 regarding the methods to be employed during cleaning validation studies.
  • Prior to performance of cleaning validation studies, review approved protocols with the appropriate Operations, QA and Laboratory personnel.
  • 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/or review cleaning validation final reports

 

Accountabilities:

  1. Performance of equipment IQ/OQ/PQ studies.
  2. Performance of process validation studies.
  3. Performance of cleaning validation studies.

 

Requirements:

  • Bachelor’s degree in a field related to Mechanical/Chemical Engineering combined with 2 years’ experience in validation 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.