Engineer Pharma Validation

Medline Industries, LP • REMOTE- Illinois, IL

3d • $79,000 - $119,000

About The Position

Responsible for validating facility utilities, equipment, processes, and cleaning for cGMP products, including pharmaceuticals, medical devices, and cosmetic products, in accordance with applicable regulatory requirements such as 21 CFR 211/210 and 21 CFR 820. The role assists with authoring and executing protocols to demonstrate that manufacturing and cleaning processes produce consistent results and quality within a controlled environment. It also manages or performs revalidation, engineering studies for new products or components, change-control assessments, and coordination of computer and method validations. The position requires up to 40% domestic and international travel.

Requirements

• 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 in a regulated environment.
• Experience with validation documentation and related change control.
• Ability to manage multiple priorities, a self-starter attitude, strong oral and written communication skills, and ability to work independently and as part of a team.

Nice To Haves

• Master of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or another 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, including liquid products, solid dosage products, and multi-component products.

Responsibilities

• Validate new equipment and revalidate existing equipment used in OTC and cosmetic manufacturing, as appropriate.
• Perform engineering studies to determine project feasibility.
• Develop, prepare, and install equipment; revise test validation procedures and protocols to ensure products are manufactured in accordance with regulatory validation requirements and current industry practices.
• Develop and execute cleaning validations.
• Manage IQ, OQ, and PQ phases.
• Coordinate directly with vendors and service providers to ensure validation and installation requirements are met during protocol execution.
• Develop project timelines and ensure deadlines and goals are met; regularly update management and the team on progress.
• Proactively identify issues that could delay projects and recommend ways to improve completion timelines.
• Compile and analyze validation data, prepare reports, and recommend changes or improvements.
• Maintain documentation related to qualification and validation of assigned projects and equipment or systems.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance.
• Life and disability insurance.
• 401(k) contributions.
• Paid time off.
• Employee Assistance Program access for employees working less than 30 hours per week.
• Employee Resource Groups for employees working less than 30 hours per week.
• Employee Service Corp access for employees working less than 30 hours per week.

What This Job Offers

• Job Type: Full-time