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 validation 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.
  • Participate and assist in process validation and cleaning validation studies as needed:
Accountabilities:
  1. Performance of equipment IQ/OQ/PQ studies.

 Requirements:

  • Bachelor’s degree in a field related to Mechanical/Chemical Engineering or equivalent 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.