Validation Engineer

Medline • Hartland, WI

5d • $73,000 - $110,000

About The Position

Responsible for the validation of facility utilities, and equipment processes 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. Assist in authoring and executing protocols to demonstrate that manufacturing processes are executed with consistent quality and results within a controlled environment. Responsible for managing and or performing revalidation, engineering studies to evaluate new products or components, change control assessments, and coordination of computer and test method validations of applicable products. Job Description Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic and medical device manufacturing. Perform engineering studies to determine if projects are feasible. Assist with measurement system analysis including Gage R&R. Support product/design transfer activities including validations and creation of updates to documentation needed to manufacture OTC cosmetic and medical devices. Support Change Assessment activities including assessment and qualification of changes to existing product components and implementation of products into manufacturing lines. Support root cause investigations for non-conformances related to manufacturing validations. 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. Responsible for IQ/OQ and PQ phases and implementation of validated SOPs. 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.

Requirements

• 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 validations of 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.

Nice To Haves

• Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, Biomedical Engineering, or Engineering.
• Six Sigma certification.
• 3 years of validation experience in a cGMP Device or Drug environment.
• Process 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.
• Experience in FDA regulated environment.
• Experience with ISO 13485 and ISO 11607 standards.
• Experience with Measurement System Analysis.
• Experience with Minitab statistical analysis software.
• Experience with root cause analysis.

Responsibilities

• Validate new and revalidate as appropriate existing equipment used in OTC/Cosmetic and medical device manufacturing.
• Perform engineering studies to determine if projects are feasible.
• Assist with measurement system analysis including Gage R&R.
• Support product/design transfer activities including validations and creation of updates to documentation needed to manufacture OTC cosmetic and medical devices.
• Support Change Assessment activities including assessment and qualification of changes to existing product components and implementation of products into manufacturing lines.
• Support root cause investigations for non-conformances related to manufacturing validations.
• 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.
• Responsible for IQ/OQ and PQ phases and implementation of validated SOPs.
• 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.

Benefits

• Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.
• Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees