KBI Biopharma Principal Engineer in Boulder, Colorado
Applies engineering expertise to process engineering projects to lead processdevelopment, process transfer and clinical/commercial manufacturing,including processing equipment and system design, procurement,installation, and support.Provides process development and process engineering direction for multipleproducts, including cross-product platforming and standardizationstrategies. Applies advanced engineering principles to develop industryapproaches for new or existing technologies and leverages these approaches toexpand KBI business opportunities.Ability to use negotiation skills drive to resolution on critical issues.Ability to summarize complex issues and present to executive management.Manages and/or applies extensive technical expertise to resolve complexproblems across multiple projects or programs. Industry Expert in at leastone area of process technology. Decisions and recommendations form the basisfor corporate decisions that can impact the reputation and businessperformance of the company. Applies a working knowledge of engineeringstandards for equipment design, implementation, and operation.Leads efforts of organization across functional boundaries. Expected tomanage staff or project leads in matrixed organizational model. Responsibleas the primary technical contact for client projects.RequirementsPH.D. IN ENGINEERING WITH A MINIMUM OF 10 YEARS OF RELEVANT EXPERIENCE, BSIN ENGINEERING WITH A MINIMUM OF 15 YEARS OF RELEVANT EXPERIENCE.EXTENSIVE EXPERTISE IN UPSTREAM OR DOWNSTREAM PROCESSING TECHNIQUES ANDEQUIPMENT IN BIOLOGICS.EXTENSIVE EXPERTISE IN TECHNOLOGY TRANSFER, SCALE UP AND EQUIPMENT DESIGN.AWARENESS AND EXPERIENCE WITH NEW TECHNOLOGIES AND PROCESS OPTIMIZATIONAPPROACHES TO DEBOTTLENECK MANUFACTURING OPERATIONS.KNOWLEDGE OF INDUSTRY BEST PRACTICES, GUIDELINES AND REGULATIONS RELATED TOPROCESS VALIDATION (PDA/ICH/BPOG) AND BOARDS OF HEALTH(FDA/ICH/EMA/PICS) IS PREFERREDEXPERIENCE WITH GMP COMPLIANCE AND WORKING IN A CGMP MANUFACTURING ENVIRONMENTIS REQUIREDKNOWLEDGE OF PROCESS DEVELOPMENT AND EXPERIENCE SUPPORTING IND DEVELOPMENT ANDEARLY PHASE GMP PRODUCTIONKBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversifyits work force. Therefore, all qualified applicants, regardlessof race, color, national origin, religion, gender, genderidentity, sexual orientation, age, disability or veteran status, arestrongly encouraged to apply.