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.
Job Description
Responsibilities:
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 (i.e. Manufacturing, Engineering, and QC Labs, etc.) in regard to 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 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 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 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.
Preferred Qualifications:
Masters of Science in Chemistry, Biology, Biotechnology, Chemical Manufacturing, or other 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.
Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.
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Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
