Engineer Pharma Validation
About The Position
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.
Requirements
- 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.
Nice To Haves
- 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 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.
Benefits
- health insurance
- life and disability
- 401(k) contributions
- paid time off
- Employee Assistance Program
- Employee Resource Groups
- Employee Service Corp
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
