Sr. Engineer Pharma Validation

Job Summary

Responsible for the validation of facility utilities, equipment processes and cleaning for cGMP products such as pharmaceuticals, medical devices, and cosmetic products to adhere to 21 CFR 211/210, 21 CFR 820, and other applicable regulatory requirements. Lead the authoring and executing of protocols to demonstrate that manufacturing and cleaning processes are executed with consistent quality and results. In addition, this role will coach and assist Pharma Validation Engineers through the validation process.

• Responsible for revalidation, engineering studies to evaluate new products or components, change control assessments, and coordination of computer and method validations of applicable products in an FDA controlled environment.
• Plan, communicate and lead scientifically sound qualification/validation strategies for large scale projects.
• Perform engineering studies to determine if projects are feasible.
• Suggest OEE improvements and suggestions as a member of the continuous improvement team.
• Communicate with appropriate functional groups (Manufacturing, Engineering, QC Labs, etc.) regarding the needs and status of assigned study execution activities.
• Manage vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols.
• Provide coaching and mentoring to the Pharma Validation team.
• 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 requirements and current industry practices.
• Develop and execute cleaning validations and be responsible for IQ/OQ and PQ phases.
• Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are satisfied.
• Develop timelines for all projects and ensure that deadlines and goals are met.
• Frequently update management and the team on progress.
• Proactively work with members of the division or project team to identify issues that might delay the project and make recommendations to improve timelines for project completion.
• Compile and analyze validation data, prepare reports, and make recommendations for changes and/or improvements.
• Maintain all documentation pertaining to qualification and validation of assigned projects and equipment/systems.

• Bachelor of Science Degree in Biology, Chemistry or Engineering.
• At least 4 years 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.
• Ability to control and coordinate concurrent projects, competing priorities and critical deadlines.
• Experience assessing and initiating actions independently.
• Experience taking charge of a situation, team or project.
• Ability to build and maintain relationships within and between teams.
• Strong oral and writing skills.

• Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or another related field.
• Six Sigma certification.
• Validation experience in a pharmaceutical or Medical Device manufacturing environment.
• Experience with NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) products.
• Experience with validation of various product types such as liquid products, solid dosage products, and multi-component products.

The anticipated salary range for this position: $ - $ Annual. This role is bonus and/or incentive eligible. Benefits include health insurance, life and disability insurance, 401(k) contributions, paid time off, Employee Assistance Program, Employee Resource Groups and other benefits available to employees working 30 or more hours per week on average. For part‑time employees the benefits are proportionate to hours worked.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.