Remote Pharma Validation Engineer | cGMP Quality

Medline; Illinois; On-site; USD 73,000 - 110,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Employee Assistance Program

Job summary

Medline Industries, LP in Illinois is seeking an Engineer for Pharma Validation responsible for validating facility utilities, equipment and cleaning to meet 21 CFR requirements, and for authoring and executing validation protocols.

The role includes IQ/OQ/PQ, revalidation, change control, vendor coordination and data analysis; up to 40% travel domestically and internationally; Bachelor's in science or engineering and 2+ years in validation preferred; Masters and Six Sigma are a plus.

Qualifications

• BS in Biology, Chemistry or Engineering required.
• At least 2 years of validation experience in a cGMP device/drug environment.
• Experience with USP water, controlled environments or equipment validations.
• Experience with validation documentation and change control.

Responsibilities

• Validate new and revalidate existing equipment used in OTC/Cosmetic manufacturing.
• Perform engineering studies to determine feasibility of projects.
• Develop, prepare and install equipment and revise validation protocols to ensure compliance with regulatory validation requirements.
• Develop and execute cleaning validations (IQ/OQ/PQ).
• Coordinate projects with vendors and service providers to satisfy validation and installation requirements.
• Develop timelines and keep management updated on progress; manage multiple priorities.

Skills

Prioritization

Self-starter

Communication

Teamwork

Education

Bachelor's degree in Biology/Chemistry/Engineering

Master's degree (preferred)

Job description

Medline Industries, LP in Illinois is seeking an Engineer for Pharma Validation responsible for validating facility utilities, equipment and cleaning to meet 21 CFR requirements, and for authoring and executing validation protocols.

The role includes IQ/OQ/PQ, revalidation, change control, vendor coordination and data analysis; up to 40% travel domestically and internationally; Bachelor's in science or engineering and 2+ years in validation preferred; Masters and Six Sigma are a plus.