Engineer Pharma Validation

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

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. Assist in authoring and executing protocols to demonstrate that manufacturing and cleaning 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 method validations of applicable products. This position requires up to 40% travel both international and domestic.

Responsibilities

• Validate new and revalidate as appropriate 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.

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.

Preferred Qualifications

• 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.

Compensation & Benefits

• The anticipated salary range for this position: $79,000.00 - $119,000.00 Annual
• The actual salary will vary based on applicant’s location, education, experience, skills, and abilities.
• This role is bonus and/or incentive eligible.
• Medline will not pay less than the applicable minimum wage or salary threshold.
• 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, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best.

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.

Through our culture of belonging, our agile and resilient global team is determined to get our customers exactly what they need, at the right time, every time.

Medline is the largest provider of medical-surgical products and supply chain solutions serving all points of care. Through its broad product portfolio, resilient supply chain and leading clinical solutions, Medline helps healthcare providers improve their clinical, financial and operational outcomes. Headquartered in Northfield, Illinois, the company employs more than 43,000 people worldwide and operates in more than 100 countries and territories.

To learn more about how Medline makes healthcare run better, visit www.medline.com.