Pharma Validation Engineer (cGMP) – Equipment & Cleaning

Medline Industries, LP; United States; Remote; USD 79,000 - 119,000; Full time

Job summary

Medline Industries, LP is seeking a Validation Specialist to ensure cGMP compliance for pharmaceutical, medical device, and cosmetic manufacturing. You will validate and revalidate equipment, perform engineering studies, and manage validation documentation in a regulated environment with up to 40% travel internationally and domestically.

The role requires a BS in Biology, Chemistry, or Engineering and 2+ years in validation within a regulated setting; advanced degrees and Six Sigma are

Qualifications

• 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 documentation and related change control.
• Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills.

Responsibilities

• Validate and revalidate equipment used in OTC/Cosmetic manufacturing.
• Perform engineering studies to determine project feasibility.
• Develop, prepare and install equipment and revise validation protocols.
• Develop and execute cleaning validations.
• Coordinate IQ/OQ and PQ phases.
• Coordinate projects with vendors to ensure validation requirements are met.
• Develop timelines and update management on progress.
• Analyze validation data, prepare reports and recommend improvements.
• Maintain documentation pertaining to qualification and validation.

Skills

Strong communication

Independent worker

Education

Bachelor of Science Degree in Biology, Chemistry or Engineering

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

Job description

Medline Industries, LP is seeking a Validation Specialist to ensure cGMP compliance for pharmaceutical, medical device, and cosmetic manufacturing. You will validate and revalidate equipment, perform engineering studies, and manage validation documentation in a regulated environment with up to 40% travel internationally and domestically.

The role requires a BS in Biology, Chemistry, or Engineering and 2+ years in validation within a regulated setting; advanced degrees and Six Sigma are