Job Description:

We are seeking a highly skilled and experienced Validation Specialist/Engineer to support commissioning and qualification activities for our client's facility in PA. The ideal candidate will have a strong background in executing validation life cycle deliverables in compliance with ISPE C&Q guidelines, with hands-on expertise in analytical instrumentation and controlled temperature unit qualifications.

Responsibilities:

• Develop, review, and execute validation life cycle deliverables (protocols, reports, and associated documentation).


• Perform commissioning and qualification activities in alignment with ISPE C&Q guidelines.


• Support the qualification of analytical instrumentation and controlled temperature units (CTUs).


• Utilize Kneat e-validation software for document development, execution, and approval (preferred).