Pharma Validation Engineer: Global Travel & Impact

Medline Industries, LP; Illinois; Hybrid; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP is seeking a validation specialist responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products to comply with 21 CFR 211/210, 21 CFR 820 and other regulatory requirements. This role requires up to 40% travel internationally and domestically.

You will author and execute validation protocols, lead revalidation and engineering studies, coordinate with vendors, and maintain documentation for qualification activities across projects

Qualifications

• Bachelor of Science Degree in Biology, Chemistry or Engineering.
• At least 2 year of validation experience in a cGMP Device or Drug environment.
• Experience with validations 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 a team in an efficient manner.
• Masters 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 with validation of various product types such as liquid products, solid dosage products, and multi-component products.

Responsibilities

• Validate new and revalidate existing equipment used in OTC/Cosmetic manufacturing.
• Perform engineering studies to determine if projects are feasible.
• Develop, prepare and install equipment and revise test validation procedures/protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirement and current industry practices.
• 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.
• Frequently update management and team on progress.
• Proactively work with members of the division or project team to identify issues that might delay the project; make recommendations to improve time lines for project completion.
• Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements.
• Maintain all of the documentation pertaining to qualification and validation of assigned projects and equipment/systems.

Skills

Attention to detail

Self-starter

Oral and written communication

Time management

Education

Bachelor of Science 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 responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products to comply with 21 CFR 211/210, 21 CFR 820 and other regulatory requirements. This role requires up to 40% travel internationally and domestically.

You will author and execute validation protocols, lead revalidation and engineering studies, coordinate with vendors, and maintain documentation for qualification activities across projects