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Sr. Bioprocess Engineer

Company: Jobleads
Location: Kansas City
Posted on: May 3, 2021

Job Description:

The Sr Bioprocess Engineer is responsible for providing scientific, technical and equipment support regarding the development of new products and existing product changes. This position will design, plan, lead and execute strategies associated with the process development, troubleshooting, or optimizations that are aimed to deliver reproducible, safe, compliant, and cost effective solutions to the industrial teams. The Sr Bioprocess Engineer will be responsible for managing, mentoring, and developing a GID Technician. Responsibilities and Key Duties: Lead the scale-up/down and transfer efforts of new processes from development to industrial Lead optimization efforts of current processes by conducting experiments to evaluate relevant process parameters for upstream, downstream, formulation and lyophilization Participate in the definition and ensure implementation of transfer and process improvement/development rationales (including technical, financial and regulatory aspects) to anticipate industrial needs Apply DoE and QbD methodologies (when applicable) to develop or improve processes Lead meetings with R&D, Industrial and Purchasing to implement an industrialization process Evaluate/analyze process performance (KPIs, CQAs, and CCPs) for process/methods improvement Define process validation strategy, assist with the generation of process validation protocols and manufacturing instructions, check and approve process validation protocol and manufacturing and testing instructions and write technology transfer plans and reports Provide expertise to production, early R&D, QA and RA teams as manufacturing process/industrialization expert for process improvement, optimal solution proposition and CapEx evaluation Exchange knowledge with other Global Industrialization teams and contribute to process improvement through sharing and promoting best practices Ensure that relevant quality and EHS standards/rules and operating protocols and documentations for GID laboratories are followed Participate in risk assessment meetings with R&D, GMSQ and Purchasing teams to identify and define critical process parameters and critical quality attributes for systems suitability evaluation Design, schedule, execute and write protocols; must be capable of utilizing statistical software Update and write GMP procedures and implement corrective and preventive actions Adheres to documentation guidelines and current SOPs related to experimentation and reporting data Lead the installation, operation and validation of new equipment ensuring maintenance of equipment and operational status Conduct training to the different team members on the proper use of equipment or processes Train, manage, mentor, coach and develop direct report(s) Participate in the creation of industrial documentation SOPs and batch records to achieve right first-time operation associated with new processes Core Competencies: Shape solutions out of complexity - Is open and curious of others perspectives Client focus - Has in mind clients 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 others work Influence others - Communicates transparently Technical / Functional Competencies: Advanced knowledge of manufacturing operations Strong communication skills, both written and verbal Technical writing skills for regulatory documentation Data management and analysis tools knowledge Capability to prepare URS for production line Ability to contribute to building an industrialization strategy from the design of new equipment and its integration into new premises Ability to scout and evaluate the potential of new technologies Ability to design and perform capability/robustness studies Ability to build statistical approach/strategy for problem-solving/improvement processes Ability to lead a team Qualifications: Education - MS/PhD in Chemical Engineering, Biochemical Engineering or equivalent Work Experience - Prefer a minimum of 3-5 years of experience within a cGMP biological production environment, with managerial experience, or an equivalent combination of education and experience Other (consider certifications, specialized knowledge and/or training, etc.) - Physical Requirements: Ability to read, write legibly and understand English Lifting, carrying, pushing, up to 25lb Frequent period of standing, Bending, walking and sitting Working Conditions: Travel Required: 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 **Ceva is an equal opportunity employer and all qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, actual or perceived sexual orientation, gender identity, disability status, protected veteran status, or anyother characteristic protected by law. Ceva encourages men and women, members of all racial and ethnic groups, individuals with disabilities and veterans to apply.

Keywords: Jobleads, Kansas City , Sr. Bioprocess Engineer, Other , Kansas City, Kansas

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