Validation Engineer

Job Title : Validation Engineer

Location : Holly Springs NC 27540

Duration - 6 Months

Start Date : 2 / 16 / 2026to End Date : 09 / 04 / 2026 (Possible extension upto long term)

Summary :

The Validation Engineer is responsible for the execution and management of validation activities for process cleaning equipment computer software or facilities on site. The engineer prepares and executes validation / qualification and requalification activities as necessary for new and modified processes cleaning equipment computer software or facilities so that the qualification status of the site is maintained at all times. The engineer also assists external qualification personnel with the execution of major project qualification activities which require the use of temporary external resources.

Primary responsibilities for role :

Ensure all company and Site Validation policies and procedures are adhered to.

Ensure all work carried out and equipment installed is safe effective and in compliance with the appropriate industry standards.

Ensure all work undertaken is reflected accurately in up-to-date Validation / project information files.

Lead / support the development of process cleaning equipment computer software or facilities protocols and ensure they are in line with Validation policies and guidance documents (Liaising with equipment manufacturers internal and external project personnel to ensure successful qualification execution).

Seek and retain approval for qualification protocols from site

User groups (who approve documents from a user group operations perspective)

Quality (who approve documents from a regulatory compliance standpoint)

Lead the execution of qualification protocols on process cleaning equipment computer software or facilities as necessary.

Ensure the maintenance of a qualification document listing for all qualified equipment on site.

Ensure all qualification documentation is maintained up to date at all times.

Provide expert guidance for the resolution of technical issues arising during the execution of qualification activities.

Perform any other activities as directed by the Validation Manager.

Key Skills

Python,SOC,Debugging,C / C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing

Employment Type : Full Time

Experience : years

Vacancy : 1