At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: Responsible 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, mainly for cleaning validation. The other disciplines may include: * Facilities qualification * Utilities qualification * Equipment qualification * Manufacturing process control system qualification * Steaming Validation * Air Visualization Studies * Mixing Studies Staff must have demonstrated experience in cleaning validation and will actively develop subject matter expertise in other disciplines. Staff will provide technical decision-making regarding cleaning validation strategies, project requirements, and change controls. This position will ensure that cleaning validation programs are effectively implemented to produce biopharmaceuticals in a multi-product facility. Additionally, this person will own and assist with developing program-related strategy, documents, and SOPs. The staff member will coordinate and execute validation testing. Staff will make recommendations for changes and improvements, and support 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 members 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 and 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. Responsibilities: * Act as primary responsible Subject Matter Expert in drafting, execution, and review/approval of cleaning 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 principal or primary consulting resource, department point of contact, and coordinating resource for operations support in the execution of validation requirements, audit responses, and inspectional readiness * Support and/or lead business and operational excellence improvements and departmental initiatives * Strong orientation for quality and customer service * Demonstrated level of respect for individuals * High level of integrity and personal responsibility Requirements: * Knowledge, Skills, Abilities * Minimum of a bachelor's degree in a scientific or biochemical engineering discipline and 6 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. Also requires a demonstrated track record in the following key areas: * Strong orientation for quality and customer service * Demonstrated level of respect for individuals * High level of integrity and personal responsibility * Language Ability * Ability to read and interpret technical documents (in the English language) such as schematic drawings, P&IDs, engineering specifications, safety rules, operating and maintenance instructions, procedure manuals, batch and production records. * Ability to write routine reports and correspondence on Facilities Eng/Val subject matter. * Ability to speak effectively before internal groups or employees of the organization. * Efficient and effective deductive and inductive critical thinking and problem-solving skills are required. * Reasoning Ability * Ability to independently solve practical problems with minimal supervision and deal with various concrete variables in situations where only limited standardization or data may exist. * Ability to interpret and apply a variety of instructions furnished, analysis, and assessments in written, oral, diagram, or schedule form. * Strong time management skills and an ability to multitask in a fast-paced environment. Ability to deliver consistent, high-quality documentation, paying attention to detail and thoroughness relative to SOP requirements. * Ability to quickly grasp complex technical concepts and make them understandable and coherent in text and graphics. * Math Ability * Ability to add, subtract, multiply, divide, and convert in all units of measure, using whole numbers, common fractions, and decimals. * Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. * Ability to utilize mathematical algorithms, formulas, physical constants, and data point measurements to demonstrate comparability and/or compliance with test acceptance or performance specification criteria. * Physical Demands * Minimal physical demands, lifting and carrying up to 25 lbs. * Computer Skills * MS Office suite, Electronic Document/Info Management Systems, engineering software tools * MS Excel spreadsheet creation and data analysis functions * Preferred: Use of control system software (computerized system validation positions) and 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 (ELLAB Probes; data loggers), Computerized workstations. Salary Range: $101,000 to $126,000 Salary range provided per current averages and expectations. The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range. KBI has a robust total rewards strategy, including an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, 401K matching with 100% vesting in 60 days, and employee recognition programs. About KBI: KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies. KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including manufacturing ten commercial products. Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe. For more information, visit www.kbibiopharma.com. KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce. We believe innovation thrives in an environment where all voices are heard and valued. That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team. KBI Biopharma is committed to providing a safe and healthy workplace. Any employee entering a KBI site located in the US must inform KBI Biopharma of their vaccination status and must submit their vaccination status. All vaccinated employees are required to provide proof of their COVID-19 vaccination, with a COVID-19 vaccination which has been granted FDA approval or Emergency Use Authorization. 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. I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me. If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice. I understand that no representative of KBI Biopharma, Inc. has the authority to make any assurance to the contrary. I attest with my signature below that I have given to KBI Biopharma, Inc. true and complete information on this application. No requested information has been concealed. I authorize KBI Biopharma, Inc. to contact references provided for employment reference checks. If any information I have provided is untrue, or if I have concealed material information, I understand that this will constitute cause for the denial of employment or immediate dismissal.