Validation
Specialist/Validation Engineer:
A Validation Specialist/Validation Engineer is a professional
position. An Validation Specialist/Validation Engineer I is responsible
for performing start-up, commissioning, and validation activities
within the scope of work from the assigned project. An Validation
Specialist/Validation Engineer I may work as a technical lead
on small/medium projects depending on the areas of expertise.
Education:
A minimum of a bachelor's degree in Chemical, Mechanical,
or Electrical Engineering or a related Science.
Experience:
A minimum of five (5) years experience in the pharm/biotech
industry with a minimum of three (3) years of technical experience
in commissioning & qualification/validation. Experiential
requirements include past experience in and hands-on knowledge
of facility/utility systems and/or process equipment in a GMP
environment with technical c apacity to execute/oversee commissioning
and qualification/validation of facility/utility systems and/or
process equipment project(s). Working knowledge of setup, programming
and calibration of thermal mapping device (Digi IV and/or validator
2000) preferred.
Software
Proficiency:
MS Office (word, excel, power point) and MS Outlook. Working
knowledge and understanding of project management software (MS
Project, Primavera, etc.) and database program (MS Access) is
preferred.
