Engineer, Validations and Facilities

About Nucleus Biologics:

At Nucleus Biologics, we are passionate about supporting the development of groundbreaking discoveries and improving the quality of life for patients. Our cell culture products and services fuel today’s therapies and tomorrow’s innovations. 

Cell culture media is a critical raw material used in the development of cell-based projects. As the Cell Performance Company™, we are the leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization. We are committed to delivering premium products and services through a transparent, consistent, and proven supply chain that eliminates variability. 

About the role

As the Engineer, Validations and Facilities at Nucleus Biologics™, you will assist the Quality - Facilities & Validations team and report into the Sr. Manager of Validations and Facilities. This individual will sit out of our San Diego, California location.  

This role will be responsible for planning, executing, and documenting validation activities to ensure that systems, processes, products, or equipment meet quality, safety, and regulatory standards; implementing validation expertise to meet validation objectives; developing validation plans that outline the scope, objectives, resources, and timelines for validation activities.  This role will support facilities assisting with day-to-day activities. This role may assist in new facility buildouts, building maintenance, documenting processes, and working with vendors. This position will report to the Sr. Manager of Validations and Facilities and be a fully on-site role.

What you'll do

Validations

• Initiates protocols for validation or performance testing of new or modified manufacturing equipment, processes, software or systems.
• Analyzes validation test data and summarizes findings to access compliance with required criteria and specifications.
• Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.
• Develops and maintains databases for tracking test results, validation activities, or validated systems.
• Develops, maintains, or reviews validation and compliance documentation including schematics, protocols, and engineering change notices.

Facilities

• Assist in ensuring that the facility is fully operational with all utilities functioning properly.
• Schedule and supervise maintenance repair work and assist with checking installation and servicing building equipment.
• Assist in oversight of security of buildings and grounds, including Alarms, building access, and CCTV.
• Assist in scheduling and managing Pest Control activities
• IT coordination, and other hardware e.g., printers & other hardware
• Freezer and refrigerator maintenance
• Backup point of contact for emergencies and creating emergency plans, safety committees, etc.
• Assist in building projects for office and cleanroom buildouts and expansions.
• Assist in management of Environmental Monitoring Systems, Utility Systems, Water Systems.
• Develop, write, update, and maintain SOPs and work instructions, as needed.
• Participate in the Company Safety Program and assist where needed.

Qualifications

EDUCATION: 

• BS/BA in engineering or other technical field  
• 5+ years’ experience in an engineering function dealing with validating processes
• 5+ years' experience supporting biotech facilities
• 3-5 years of experience in a GMP or ISO 9001/13485 environment

REQUIRED EXPERIENCE:

• Working knowledge of GMP, ISO, and FDA rules and regulatory requirements.
• Working knowledge of OSHA and other environmental regulations.
• Knowledge of cGMP manufacturing, ase