QA Validation Engineer
 Biomune Company | ||
 United States, Kansas, Lenexa | ||
| 8906 Rosehill Rd (Show on map) | ||
 Nov 10, 2024 | ||
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QA Validation Engineer The success of a company depends on the passionate people we partner with. Together, let's share our talents. Your Location: Lenexa, KS
The QA Validation Engineer, for Biomune Company, d/b/a Ceva Biomune in Lenexa, KS, leads, designs, performs and reports validation activities on processes, equipment and systems that are used in the manufacture of regulated veterinary vaccines for domestic and international markets. Validation is a key component of Ceva's regulatory compliance strategy. Responsibilities and Key Duties: Prepares and executes protocols including Cycle Development, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Engineering Studies (ES), Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). Reviews protocol drafts and resolves conflicts and concerns in order to achieve management pre- approval. Coordinates the execution of qualifications and all aspects of the validation project with other departments, including but not limited to: Operations, Engineering, Quality Control and Quality Assurance. Performs or supervises the execution of protocols and maintains documentation as evidence of compliance with current Good Documentation Practices. Reviews, analyzes and compiles protocol data and writes reports for management review and approval. Performs and documents risk assessments to determine validation strategy and approach. Executes Re-qualification (RQ) studies and periodic reviews, to assure equipment, systems and processes maintain qualified and validated condition. Ensures equipment used for qualification purposes is properly maintained and calibrated. Supports and participates in change control process for qualified and validated equipment like refrigerators, freezers, incubators, autoclaves, lyophilizers, bioreactors, fermenters, ovens, ampule filling machines, and systems. Fully understands the requirements of each change control procedure. Troubleshoots and resolves issues with equipment as it impacts the validated condition. Provides input to, reviews and approves User Requirements Specifications (URS). Writes, reviews and edits standard operating procedures to align with validation requirements. Provides input to Engineering on the preparation and execution of Factory Acceptance Test (FAT) and Site Acceptance Test (SAT). Research equipment and processes and establishes parameters and methods to test equipment to meet validation requirements. Supports the development of Validation Plans and Schedules. Works overtime, alternate shifts and/or weekends when necessary to execute protocols. Performs other duties as assigned and required. Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversees that processes are in CGMP compliance and establishes systems that identifies opportunities for improvement and makes constructive suggestions for changes to improve process effectiveness to heighten quality. Develops knowledge of and understands regulatory requirements such as, USDA, cGMP's, Eudralex, and other regulatory agencies. Core Competencies: * Shape solutions out of complexity - Is open and curious of other's perspectives * Client focus - Has in mind client's satisfaction * Collaborate with empathy - Has a positive attitude towards collaboration * Engage and develop - Clarifies short-term directions * Drive ambition and accountability - Proactively manages own and other's work * Influence others - Communicates transparently Technical / Functional Competencies: Ability to perform internal and study audits as a lead and external audits as part of the audit team * Knowledge of pharmaceutical development, regulatory and manufacturing sciences with a global overview * Knowledge and understanding of Ceva's organization, products and processes within area of operation * Knowledge of continuous improvement tools and investigation tools in order to propose solutions * Knowledge of the specific technical standards, guidelines and tools * Capability to challenge counterparts and adapt solutions * Mastery of office software (i.e. Electronic Document Management System) * Knowledge of quality systems tools with the ability to adapt them to the organization to reach the right level of quality requested by main global regulations (GLP, GCP, GMP) and with the ability to present them during regulatory inspections * Capacity to validate programming of excel files according to objectives Proficient in use of data logging equipment and instruments Demonstrated ability to communicate effectively with others Strong written and verbal communication skills Excellent interpersonal skills and networking skills Ability to organize and prioritize multiple tasks Ability to work independently as well as part of a team Strong decision-making skills Ability to trouble shoot and understand technical data Ability to work flexible hours as needed Qualifications Education - Requires a bachelor's or Master's Degree in Engineering, Biotechnology, Biology, Microbiology, Science or related or equivalent. Requires, with a bachelor's four (4) or with a master's two (2) years of validation experience in the biotech, biological, pharmaceutical or other GMP-regulated industry. Work Experience - The experience must include (if Bachelor's 4 or if Masters 2 years): use of data logging equipment and instruments; Aseptic processes; technical writing; Microsoft Word and Excel; and hands-on experience in qualification of one of the following: refrigerators, freezers, incubators, autoclaves, lyophilizers, bioreactors, fermenters, ovens, ampule filing machines, classified environments, media fills, sterilization processes, environmental monitoring, cleaning validation, process validation, method validation. Other - Experience performing risk assessments, investigations, CAPA's and Aseptic Process Simulations (APS or media fills) preferred. Physical Requirements: * Ability to read, write legibly and communicate in English * Visual inspection * Occasional lifting up to 25 lbs * Tasks frequently require prolonged, mental, and visual concentration Working Conditions: Hours: M - F, 40 hours/week. Work overtime, alternate shifts and/or weekends when necessary to execute protocols. Travel Required: N/A This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.
*VEVRAA Federal Contractor 669B Your Qualifications | ||