Technologist, Metrology & Validation Design - Contractor

Responsible for all process and equipment validation design within division(s). Assure validation compliance and oversee the development of process and validation specific training requirements for direct reports and divisional employees.  Responsibilities also include the management of equipment calibrations, creation of divisional specific metrics, overseeing the building environmental monitoring system and serving as SME for all divisional audits. 

• Join a team of highly qualified operators and provide validation services to the division(s) within Celularity by participating in validation activities. 
• Work cohesively with cross-functional teams in support of operational efficiency, flexibility, and assurance of timely completion of validation activities. 
• Operate in classified manufacturing environments and clean room suites. Ability to gown appropriately for clean room/aseptic operations as required.  
• Participate in the development of qualification protocols and final reports. 
• Execute asset qualification protocols.  Investigate and troubleshoot any deviations observed during protocol execution.  Demonstrate ability to adhere to Good Documentation Practices. 
• Building Environmental Monitoring System (BEMS) Management.  Respond to and notify functional area management of any excursions and alarms that may occur.  Develop reports on a weekly and monthly basis.  Initiate non conformance and investigate to determine possible root cause of excursion/alarm. 
• Asset Management. Ensure the proper operation of manufacturing assets via calibration, preventative maintenance and performance verification activities.  Support research and development asset needs as required.  Enter asset activities into the asset management software.  Accurately complete asset logbooks and associated records as required.    
• Participate in the development of operation SOPs and maintenance SOPs for manufacturing assets. 

Minimum Qualifications (Must have)  

• B.S degree in Biology, Bioengineering or related scientific discipline  
• Strong organizational and time management skills 
• Ability to work well in a team environment 
• Excellent verbal and written communication skills as well as strong focus and attention to detail 
• Flexible scheduling required 

Preferred Qualifications  

• 1+ years’ relevant experience in manufacturing and operation within cGMP environments 
• Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211) 
• Demonstrate scientific creativity, technical proficiency, and knowledge of scientific concepts 
• Understanding of clinical cGMP manufacturing operations and related gowning 
• Knowledge of GxP regulations (cGTP, cGDP, cGMP) 
• Experience in a fast-paced, scientific start-up environment  
• Dynamic individual with the ability to communicate and engage others 
• Independent and self-starting 
• Eager and adaptable  

Working Conditions  

• Position operates in classified clean room environments requiring gowning in company provided scrubs, PPE and cleanroom attire 
• Fast paced, start-up environment which may periodically require work beyond standard business hours 
• Handling of equipment, instruments and systems that have been potentially exposed to biohazardous material (human cells, tissues, etc.).   

#ZR