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SME - Bioprocess - Raleigh, NC or Remote

Exyte is a global leader in the design, engineering, and delivery of facilities for high-tech industries. With a history of more than 100 years, the company has developed a unique expertise in controlled and regulated environments. Exyte has a truly global footprint, serving the most technically demanding clients in markets such as semiconductors, batteries, pharmaceuticals, biotechnology, and data centers. The company offers a full range of services from consulting to the managing of turnkey solutions – delivered to the highest quality and safety standards. Solving the most complex challenges, Exyte forges trusted, long-lasting relationships with its clients. In 2019, Exyte generated sales of EUR 3.9 billion with around 5,200 highly experienced and motivated employees. The company is ideally positioned to further strengthen its market leadership with its broad industry insight and its exceptional talents. www.exyte.net  

Summary
This is an SME role with deep experience in all phases of biomanufacturing design and operations.  The focus areas would include both fed-batch and continuous manufacturing platforms, new modalities such as ATMPs and ADCs, and the skills to identify/address risk and operational efficiency.  Must be proficient in communications of operational analysis and design basis in order to align Customer needs and expectations with deliverables.

Duties
•Ensures customers are provided with the right technical solution within process discipline
•Inspires customers by providing innovative solutions/options for project feasibility and conceptual design
•Develops technical solutions around operational and business goals
•Conducts reviews of risks and facilitates implementation of design approaches to mitigate those risks
•Uses specialist Subject Matter Expert (SME) knowledge and experience to solve complex tasks around biologics drug substance manufacturing operations
•Develops and implements tools for risk assessment and early-phase project execution framework
•Delivers on-the-job knowledge sharing/training/mentoring within process discipline of BLS
•Follows Industry technology trends and maintains knowledge within key technical disciplines
•Conveys and shares knowledge within the Company
•Reviews and assess lessons learned from projects, recommends improvements of tools/methods, and gives input to implementation
•Reviews compliance aspects of process design against global regulatory standards, focused on CPPs
•Supports development of new methods/tools for process design execution and improves existing solutions supporting an operational approach
•Be engaged in local professional network
•Participates actively in global site efforts as requested
•Delivery of special courses/practical training in field of expertise
•Other duties as assigned

Requirements
•Masters of Science degree, PhD, and/or PE license in Process Engineering required
•15+ year of consulting experience in bio-manufacturing preferred
•5 - 10 years of experience in bio-manufacturing operations a plus

 

 

Attractive salaries, supportive environments and excellent benefits allow for growth and career development with Exyte Group.

 

NO OUTSIDE RECRUITERS OR AGENCIES

 

Exyte Group is an Equal Employment Opportunity Employer. The Exyte Group provides equal employment opportunities to all qualified applicants without regard to race, sex, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, or genetic information.


Nearest Major Market: Raleigh

Job Segment: Consulting, Engineer, Process Engineer, Design Engineer, Technology, Engineering