Engineer Pharma Validation

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

Location: United States

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.

Job Description

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.

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, paid time off, as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

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.

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.

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.