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Sr Pharma Validation Engineer
at Medline Industries
Responsiblefor executing the validation of facility utilities, equipment processes andcleaning for cGMP products. This key role will lead the authoring and executingprotocols to demonstrate that manufacturing and cleaning processes are executedwith consistent quality and results. In addition, this role will coach andassist Pharma Validation Engineers through the validation process.
- Responsiblefor revalidation, engineering studies to evaluate new products or components,change control assessments, and coordination of computer and method validationsof applicable products in an FDA controlled environment.
- Plan,communicate and lead scientifically sound qualification/validation strategiesfor large scale projects.
- SuggestOEE Improvements and suggestions as a member of the continuous improvementteam.
- Communicatewith appropriate functional groups (i.e. Manufacturing, Engineering, and QCLabs, etc.) in regard to the needs and status of assigned study executionactivities.
- Managevendors and service providers to ensure that all validation and installationrequirements are being satisfied during the execution of protocols.
- Providecoaching and mentoring to Pharma Validation team.
- Develop,prepare and install equipment and revise test validation procedures/protocols toensure that a product is manufactured in accordance with appropriate regulatoryagency validation requirement and current industry practices.
- Responsiblefor IQ/OQ and PQ phases.
- Coordinateprojects directly with vendors and service providers to ensure that allvalidation and installation requirements are being satisfied during theexecution of protocols.
- Developtimelines for all projects and ensure that deadlines and goals are being met.Frequently update management and team on progress.
- Proactivelywork with members of the division or project team to identify issues that mightdelay the project; make recommendations to improve time lines for projectcompletion.
- Compileand analyze validation data, prepare reports, and make recommendations forchanges and/or improvements.
- Maintainall of the documentation pertaining to qualification and validation of assignedprojects and equipment/systems.
- Bachelorof Science Degree in Biology, Chemistry or Engineering.
- Atleast 5 years of validation experience in a cGMP environment.
- Experiencewith validations of USP water, controlled environments or equipment validationsin a regulated environment.
- Experiencewith validation documentation and related change control.
- Experiencecontrolling and coordinating concurrent projects, competing priorities andcritical deadlines.
- Experienceassessing and initiating actions independently. Experience taking charge of asituation, team or project.
- Experienceassessing and responding productively to change in a timely manner.
- Experiencebuilding and maintaining relationships within and between teams.
- Validationexperience in a pharmaceutical or Medical Device manufacturing environment.
- Experiencewith NDA (New Drug Application) and ANDA (Abbreviated New Drug Application)products.
- SixSigma certification.