Job Title:
Head of Engineering

Company: CARsgen Therapeutics

Location: Raleigh, NC

Created: 2024-04-23

Job Type: Full Time

Job Description:

Key Responsibilities:Make sure to apply quickly in order to maximise your chances of being considered for an interview Read the complete job description below.Facility design and renovation.Construction project management.Harmonization of facility engineering systems and maintenance and HSE procedures and practice.Office accommodation/Cleanroom manufacturing space/Warehousing.Ensure equipment life cycle maintenance, manufacturing facility cleaning activities planning timeliness, building maintenance, and enforcement of safety and security measures.Develop and implement comprehensive engineering, maintenance, and facility strategy for multiple buildings as well as the supporting policies and procedures.Partner with key stakeholders including Manufacturing, Technology Transfer and Support, Process Development, and Quality to meet user requirements and optimal functioning of all manufacturing, laboratory, and building spaces.Act as a subject matter expert for review, approval, and updating of critical building documentation, including Architectural Plans/Drawings, Engineering Drawings, Piping & Instrumentation Drawings (PID), Facility Maps/Diagrams, GMP Process Drawings, IT Network Documentation/Diagrams.Compliance with all state, federal, and regulatory governing agencies.Requirements:Leadership experience in designing, building, and validating facilities associated with phase 1 to 3 manufacturing, pre-positioned to be commercially compliant, inspection ready and licensable by USFDA and EMA health authorities.Experience overseeing FDA regulated manufacturing facilities management projects.Design and maintain clean room ISO 7 and above, GMP Calibration, Metrology, HVAC, electrical systems, plumbing systems.Bachelor's Degree.5+ years of high-level managerial experience within one or more areas including Construction, Process, Engineering, Facilities/Engineering Maintenance.3+ years of Biotech experience.