Remote Pharma Validation Engineer (cGMP)

Medline; Illinois; Remote; USD 79,000 - 119,000; Full time

Benefits offered by this job

Travel up to 40%

Job summary

Medline Industries, LP is seeking an Engineer Pharma Validation to validate facility utilities, equipment processes and cleaning for cGMP products in a regulated environment. You will author and execute validation protocols and manage revalidation, engineering studies, and change control while coordinating with vendors and service providers to meet project timelines.

The role requires up to 40% travel domestically and internationally, with strong documentation skills and the ability to work

Qualifications

• 2+ years of validation experience in a cGMP environment.
• Experience with cleaning validations and USP water validation.
• Ability to author and execute qualification protocols.
• Proactive communication with vendors and team.

Responsibilities

• Validate new and revalidate existing equipment used in OTC/Cosmetic manufacturing.
• Develop, prepare and install equipment and revise test validation procedures.
• Develop and execute cleaning validations.
• Responsible for IQ/OQ and PQ phases.
• Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols.
• Develop timelines for all projects and ensure that deadlines and goals are being met.
• Maintain all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems.

Skills

Validation experience

cGMP knowledge

Regulatory documentation

Project coordination

Education

Bachelor of Science Degree in Biology, Chemistry or Engineering

Six Sigma certification

Master of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or related field

Tools

IQ/OQ/PQ procedures

Validation protocols

Job description

Medline Industries, LP is seeking an Engineer Pharma Validation to validate facility utilities, equipment processes and cleaning for cGMP products in a regulated environment. You will author and execute validation protocols and manage revalidation, engineering studies, and change control while coordinating with vendors and service providers to meet project timelines.

The role requires up to 40% travel domestically and internationally, with strong documentation skills and the ability to work