The Commissioning Qualification Validation Consultant position is responsible for performing and completing validation assignments.

This is a fulltime, exempt role*

ESSENTIAL FUNCTIONS

Develop Installation, Operational and Performance qualification documents. Preparing and executing validation documents for multiple systems.

Execute protocols including complex systems such as process validation, medical devices, complex manufacturing equipment, formulation systems and basic knowledge of laboratory validation (not required but preferred).

Will work in one or more validation subjects; such as laboratory equipment, temperature mapping, devices, process equipment, packaging equipment, cleaning, computers, HVAC or controls.

Monitor and report on the execution of multiple validation tasks.

Understanding the hours budgeted for completion of each task on a specific project.

Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management, and peers.

Interpretation of 21 CFR Part 11, 210, 211, and 820 as well as understanding of FDA cGMPs, FDA Guidelines and European Guidelines (where applicable).

Travel is required.

Other duties as assigned.

REQUIREMENTS

Experience in executing protocols including systems such as Process Validation, computer-controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems.

Excellent verbal communication and technical writing skills.

B.S. / B.A. in Engineering or Science or related field as a minimum.

4 years of relevant work experience in lieu of education requirement.

Basic knowledge of laboratory validation is preferred (not required but preferred).

Ability to work with multiple individuals (where applicable); ability to execute multiple tasks associated within the validation field.

Ability to monitor and report on the execution of multiple validation tasks on a routine basis.

ability to sit and type for long periods of time. Ability to read, prepare and analyze data for development of reports, ability to read and assemble summary documents as required.

Proficient in Microsoft Word, Excel, Power Point and Project.

Must be willing to travel regionally and / or nationally throughout the US.

Last updated : 2024-06-15