Validation Engineer / Associate

7/22/20

Langhorne, PA 19047

1016

FullTimeRegular

Validation Engineer / Associate

Reports to: Validation Manager

Ensure the timely development, execution and approval of assigned validation activities/ documentation includes IQ/OQ/PQ protocols, Standard Operating and Preventive Maintenance Procedures compliance with in-house specifications, standards and procedures, and implementing industry best practices. This role will perform the validation activities pertaining to the equipment and process per schedule requirements.

JOB RESPONSIBILITIES:

  • Contributes directly to the completion of validation projects through the development of validation schedules, master plans, validation protocols and reports for systems that may be complex in nature.
  • Schedule and plan equipment and process qualification activities to meet the approved schedules.
  • Actively participate among cross-functional teams and lead project initiatives to ensure projects are delivered on time and to required quality standards.
  • Establish critical parameters, plan, design, and implement validation projects and protocols (Write, execute, and review complex protocols).
  • Preparation and execution of Annual calibration/validation schedules and ensure its timely execution.
  • Preparation, review and interpret the drawings related to the process and equipment operation.
  • Use theoretical and applied knowledge of utilities, instrumentation, validation and GMP regulations applicable to automated facilities and utility systems.
  • Conduct field inspections including piping and equipment walk downs, operational startup and troubleshooting.
  • Temperature mapping studies of warehouses/storage equipment.
  • Manage and populate equipment lists and equipment data sheets.
  • Handle multiple projects and work independently.
  • Have the ability to problem solve with little oversight, including conducting research to aid in the resolution of issues that arise.
  • Purchase supplies and equipment for validation activities.
  • Administer the site Change Control Program.
  • Other responsibilities, as required by management such as procurement support, mentoring, leadership, and contractor oversight.

ESSENTIAL JOB REQUIREMENTS AND QUALIFICATIONS:

  • Possess B.S. in engineering / Science / Chemistry are preferred.
  • Preferred to have 1-3 years technical experience that includes pharmaceutical manufacturing, and project management
  • Ability to manage and plan multiple projects
  • Analytical skills, good problem-solving technique and data analysis skills with Excel
  • Excellent communication skills, both written and verbal
  • Outgoing and collaborative in nature
  • Detail Oriented
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