Engineer Pharma Validation

Overview

Validate facility utilities, equipment, processes and cleaning for cGMP products such as pharmaceuticals, medical devices and cosmetic products, in line with 21 CFR 211/210, 21 CFR 820 and other applicable regulatory requirements.

What you'll do

• Validate new equipment and revalidate existing equipment used in OTC/Cosmetic manufacturing.
• Perform engineering studies to determine whether projects are feasible.
• Develop, prepare and install equipment, and revise test validation procedures and protocols so products are manufactured to regulatory and industry validation requirements.
• Develop and execute cleaning validations.
• Be responsible for IQ/OQ and PQ phases.
• Coordinate projects directly with vendors and service providers to satisfy validation and installation requirements during protocol execution.
• Develop project timelines and ensure deadlines and goals are met.
• Frequently update management and the team on progress.
• Work with division or project team members to identify issues that might delay projects and recommend timeline improvements.
• Compile and analyze validation data, prepare reports, and recommend changes and/or improvements.
• Maintain all documentation pertaining to qualification and validation of assigned projects and equipment/systems.
• Assist in authoring and executing protocols, and manage or perform revalidation, engineering studies for new products or components, change control assessments, and computer and method validations of applicable products.

What you'll need

• Bachelor of Science degree in Biology, Chemistry or Engineering.
• At least 2 years of validation experience in a cGMP Device or Drug environment.
• Experience with validation of USP water, controlled environments, or equipment validations in a regulated environment.
• Experience with validation documentation and related change control.
• Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills, and the ability to work independently and as part of a team efficiently.

Nice to have

• Master of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other related field.
• Six Sigma certification.
• 3 years of validation experience in a cGMP Device or Drug environment.
• Validation experience in a pharmaceutical or medical device manufacturing environment.
• Experience validating various product types such as liquid products, solid dosage products, and multi-component products.

Details

• Location: Remote, Illinois.
• Travel: up to 40%, both international and domestic.
• Employment type: full-time salaried role with bonus and/or incentive eligibility.