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Validation Engineer III

Company: KBI Biopharma
Location: boulder
Posted on: May 3, 2021

Job Description:

Job DescriptionResponsible for facilitating the validation lifecycle process for the Validation Department as a Level III resource to support cGMP manufacturing operations for biopharmaceutical products. This position will provide support for more than one area of subject matter expertise for validation disciplines which may include: Facilities qualification Utilities qualification Equipment qualification Manufacturing process control system qualification Cleaning validation Steaming Validation Air Visualization Studies Mixing Studies. Responsibilities Staff must have demonstrated experience in at least on validation discipline and will actively develop subject matter expertise in other disciplines. Staff will provide technical decision making regarding validation strategies and requirements for projects and change controls. This position will ensure that validation programs are effectively implemented to produce biopharmaceuticals in a multi-product facility. Additionally, this person will own and assist with the development of program related strategy, documents and SOPs. Staff member will coordinate and execute validation testing. Staff will make recommendations for changes and improvements and supports business efficiency improvement projects. Staff may be required to develop business cases and lead operational efficiency projects. Staff will own deviation, CAPA, and change control execution deliverables. Staff will be responsible for providing change control assessments. Staff member will be expected to provide exceptional customer service to internal and external clients. Staff must have the ability to interface effectively with personnel across quality, engineering and other technical disciplines. The staff member must possess the ability to work independently, as a member of a team (including matrixed organizational structures), and to work with external contractors to meet project needs and timelines. Additionally, staff may assist with inspection preparation, project coordination and other related Validation tasks, as needed. Staff is expected to represent KBI and its programs with regulatory agencies as well as business partners. Knowledge of Quality Systems and cGMP requirements for multiple regulatory jurisdictions (FDA, EU, ICH) and the ability to effectively evaluate risk is required. Act as primary responsible Subject Matter Expert in drafting, execution, and review/approval of validation documentation, deviations, CAPAs, and change controls Conform to all Quality System and cGMP requirements for documentation and data integrity Lead risk and impact assessments pertaining to engineering and pre-requisite support of validation work processes Subject Matter Lead in the review of Engineering Specifications (URS, FRS, DDS etc.) Act as a principle or primary consulting resource, department point of contact, and coordinating resource for operations support in execution of validation requirements, audit responses, and inspectional readiness. Support and/or lead business and operational excellence improvements and departmental initiatives. Requirements Minimum of Bachelor's degree in a scientific or biochemical engineering discipline and ten plus years experience manufacturing recombinant proteins in a fermentation and/or cell culture environment along with a significant track record of accomplishments in meeting aggressive manufacturing timelines. Previous validation experience in at least one validation discipline. MS Excel spreadsheet creation and data analysis functions Preferred: Use of control system software (computerized system validation positions) and use of statistical software (any position). Equipment Use: Working knowledge and awareness of safety factors related to facility/utility support equipment (HVAC; Purified Water; Clean Steam, and Clean Process Air); unit operations process equipment (fermenters; filtration skids), process support equipment (sterilizers, washers); Temperature mapping instrumentation (Kaye Validators w/ sim modules; data loggers), Computerized work stations. Work occasionally requires engineering studies and validation protocol execution to occur outside of 1st shift hours (8AM-5PM) to accommodate the availability of equipment/systems in support of the manufacturing schedule. Work responsibilities will also potentially include coordinating work processes and testing on energized systems with specific safety protocols. Position responsibilities may also require travel to other KBI sites to support Validation work. Any validation engineer performing cleaning validation may be exposed to corrosive chemicals. Any validation engineer performing steaming validation may be exposed to thermal risk. Any validation engineer executing on the floor may be exposed to electrical, mechanical, or pressure safety hazards. Additionally, there may be exposure risk associated with process materials. All safety training is required to be complete and risks reviewed prior to performing work. As required, trained support is available to assist with tasks to ensure a safe work environment. KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.Read More

Keywords: KBI Biopharma, Boulder , Validation Engineer III, Other , boulder, Colorado

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