cGMP Facility Specialist - CICET

Position Summary

The cGMP Facility Specialist supports daily operations and monitoring, ensuring compliance with regulatory and QA standards for the Columbia Initiative in Cell Engineering and Therapy (CICET) cGMP manufacturing facility at Columbia University Irving Medical Center. This role is essential for maintaining operational readiness, environmental monitoring programs, and regulatory documentation required for manufacturing cGMP- and clinical-grade cell and gene therapy products.

Working under the direction of the CICET cGMP Facility Manager, the Specialist collaborates with CUIMC Facilities, Environmental Health & Safety (EH&S), CICET leadership, and external vendors to ensure that the facility operates in accordance with cGMP, FDA, and institutional safety and compliance standards. The position combines hands-on facility monitoring, technical operational support, and regulatory documentation to maintain a compliant, efficient cGMP cleanroom environment that supports clinical research and therapeutic manufacturing programs.

Responsibilities

Environmental Monitoring and Cleanroom Compliance

• Perform routine environmental monitoring activities in accordance with cGMP requirements, including air, surface, and gas sampling within cGMP cleanroom spaces.
• Operate viable and non-viable air sampling devices and document environmental monitoring results in accordance with established procedures.
• Track and process environmental monitoring samples, including labeling, incubation, reading, and documentation of microbiological results.
• Enter monitoring data into laboratory information management systems (LIMS) and maintain accurate records for regulatory compliance.
• Identify and escalate environmental excursions or atypical monitoring results to the Facility Manager and relevant stakeholders.

Facility Operations and Daily GMP Support

• Perform routine facility walkthroughs to maintain compliance with cGMP operational and cleanliness standards.
• Conduct daily and weekly facility inspections to ensure operational readiness of cleanroom environments and support equipment/instruments.
• Monitor facility conditions, including temperature, humidity, environmental control systems, and equipment/instrument functionality.
• Respond to facility and equipment alarms and assist with alarm management protocols to ensure timely resolution of operational issues.

Equipment and Infrastructure Support

• Assist with monitoring and maintenance of facility infrastructure, including HVAC systems, gas delivery systems, and liquid nitrogen systems.
• Coordinate preventive maintenance and calibration activities for critical equipment in collaboration with CUIMC Facilities and external service providers.
• Support installation, qualification, and validation activities (e.g., IQ/OQ) for new facility equipment/instruments.
• Coordinate vendor access to the facility and verify and supervise appropriate cleanroom entry procedures and compliance with facility requirements.

Documentation and Regulatory Compliance

• Maintain accurate facility documentation, including logs, environmental monitoring records, and equipment documentation.
• Assist with the preparation and maintenance of standard operating procedures (SOPs) and other controlled documents.
• Support deviation documentation, CAPA activities, and documentation required for internal or external audits and regulatory inspections.
• Ensure all documentation and facility activities meet cGMP and FDA regulatory requirements.

Procurement and Inventory Management

• Coordinate receipt and inspection of facility supplies, ensuring proper barcoding of supplies and timely storage and documentation upon arrival.
• Maintain accurate inventory records for GMP facility materials and supplies.
• Assist with procurement activities to ensure the continuous availability of critical facility materials and equipment supplies.

Cleaning Coordination and Facility Readiness

• Coordinate cleanroom cleaning schedules and prepare spaces for scheduled cleaning activities.
• Work with environmental services personnel to ensure proper cleaning procedures are followed within cGMP areas.
• Perform cleanroom cleaning activities when required to maintain cGMP standards and operational readiness.

Project and Administrative Support

• Assist the Facility Manager with maintenance work orders and facility improvement projects.
• Support tracking of facility maintenance activities and project timelines.
• Maintain digital records and tracking systems related to facility operations and quality management.

Environmental Health & Safety (EH&S), Training, and Collaboration

• Participate in Environmental Health & Safety programs, safety inspections, and emergency preparedness activities.
• Complete required training related to cGMP operations, safety protocols, and facility procedures.
• Collaborate with CICET leadership, QA/QC and PD teams, CUIMC Facilities, EH&S, and external vendors to ensure compliant facility operations.
• Escalate operational or safety concerns promptly to the Facility Manager and relevant leadership.

Minimum Qualifications

Educational Requirements

• Bachelor’s degree in Biology, Microbiology, Life Sciences, Engineering, or a related scientific discipline, or an equivalent combination of education and experience.

Technical Knowledge and Skills

• Basic knowledge of cGMP regulations and cleanroom operations.
• Familiarity with environmental monitoring practices and microbiological sampling techniques.
• Working knowledge of standard office software, including Microsoft Outlook, Word, Excel, PowerPoint, Teams, and SharePoint.

Skills and Abilities

• Strong organizational skills and attention to detail, particularly for regulatory documentation.
• Commitment to regulatory compliance, safety, and operational excellence.
• High level of integrity and professionalism in handling confidential and sensitive information.
• Ability to manage multiple priorities and perform operational tasks in a regulated environment.
• Strong written and verbal communication skills.
• Ability to work independently and collaboratively with cross-functional teams.
• Proactive problem-solving and ability to escalate operational issues appropriately.

Interpersonal Skills

• Strong interpersonal and customer service skills with the ability to collaborate effectively with internal teams and external vendors.
• Professionalism and commitment to maintaining compliance, safety, and operational excellence.

Preferred Qualifications

• 1–2 years of experience in a cGMP-regulated environment, laboratory operations, manufacturing facility, cleanroom operations, or academic research manufacturing environments.
• Familiarity with facility monitoring systems, environmental monitoring programs, or LIMS platforms.
• Experience supporting GMP documentation processes, including SOP development, deviations, and CAPA activities.
• Knowledge of preventive maintenance programs and facility infrastructure systems.
• Proficiency in Smartsheet, or similar project management systems.
• Experience supporting cell and gene therapy manufacturing or biologics production environments.

Other Requirements

Working Conditions

• This position requires on-site work in a cGMP cleanroom environment at Columbia University Irving Medical Center.
• Required use of personal protective equipment (PPE) and cleanroom gowning.
• Work may occasionally require off-hours availability to respond to facility and equipment alarms or operational issues.

Physical Requirements

• Ability to move between research laboratory and cGMP facility areas throughout the workday.
• Ability to lift and transport materials up to approximately 40 pounds.
• Ability to perform manual tasks related to facility operations, equipment monitoring, and supply handling.