Process Validation Engineer II

Catalent

1d•Onsite

About The Position

This Process Validation Engineer II provides direct validation support to pharmaceutical development and manufacturing operations at Catalent’s Greenville, N.C. facility. This state-of-the-art facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. The role involves performing quality functions under minimum supervision to ensure accurate execution and documentation of all assigned activities and projects.

Requirements

Bachelor’s degree in a Technical or Life Sciences discipline with two years of experience in the pharmaceutical industry; or Associate degree in a Technical or Life Sciences discipline with four years of experience in the pharmaceutical industry.
One year of validation experience.
Some exposure to hazardous chemicals and other active chemical ingredients.
Capacity to handle and manipulate objects using hands and arms.

Nice To Haves

Oral solid dosage (OSD) experience.
Process validation experience.
Experience in a Catalent production role with a demonstrated solid understanding of internal manufacturing processes may be considered in lieu of direct validation experience.

Responsibilities

Collaborate with the Cleaning Verification and Validation Analytical Group to develop draft cleaning verification and validation protocols.
Review cleaning validation protocols, residue limits, reports, and cleaning verification/validation summary packages.
Evaluate the impact of planned and unplanned changes to formulations, processes, or equipment on cleaning validation status.
Author and review equipment and utilities qualification protocols and summary reports.
Review executed qualification protocols and summary reports for completeness, accuracy, and compliance.
Assist with the execution of equipment and utilities qualification activities as required.
Ensure validation documentation is archived in accordance with GMP documentation retention requirements.
Other duties assigned.