Responsibilities

• Responsible for ensuring safe and compliant facility operations at Orca Bio’s production sites in Sacramento.
• Manage lab and building infrastructure functionality.
• Ensure that equipment and instruments are maintained and calibrated on time and to appropriate GMP standards.
• Accountable for all facilities-related SOPs, policy documents, and documents related to work order completion, vendor services, testing data, and equipment.
• Ensure effective use of the maintenance and asset management systems and drives improvements to the program as required.
• Responsible for overseeing the execution of small-to-midsize capital construction projects to upgrade or expand our Sacramento facilities and equipment. Makes sure that these projects are planned to effectively meet site needs and executed accordingly.
• Serve as the Facilities partner for mid-to-large scale capital construction projects.
• Provide strategic planning for all aspects of the Sacramento facilities, including future space requirements and providing stage-appropriate workspace solutions for our anticipated growth.
• Accountable for the Environmental, Health and Safety (EH&S) program for the sites in Sacramento.
• Ensures compliance of the site and site operations relative to applicable state and federal regulations, including OSHA and FDA.
• Maintains all EH&S records, including exposure monitoring and generate reports as required.
• Initiates, leads and implements EH&S improvement projects. Provides EHS guidance on facility’s maintenance and construction projects to minimize or eliminate adverse impacts.
• Expected to be the facilities, utilities and EH&S subject matter expert and first point of contact for facilities and EH&S questions related to audits and associated compliance.
• Provides leadership to peers and staff. Fosters open and honest communication. Promotes a collaborative culture where you lead by example.

Qualifications

• Bachelor’s degree plus minimum of 10 years of Engineering/Facilities experience and 6+ years related experience in the biotech industry within a GMP manufacturing/operations function.
• Strong technical knowledge of manufacturing and QC lab needs, and knowledge of cGMP requirements as they relate to manufacturing and lab environments.
• Experience working with Federal, State and local agencies, including the fire department and OSHA to ensure compliance with local laws.
• Understanding of lab based EH&S disciplines. Experience managing hazardous waste and biowaste operation, biosafety, chemical safety and occupational safety
• Able to work in a fast-paced and dynamic environment with competing priorities; successfully drive projects forward to meet program/project deliverables
• Regularly seeks opportunities to improve existing processes and drive change that positively impacts organizational success
• Excellent and effective written, verbal communication and presentation skills.
• Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation.
• Operates with transparency. Excellent judgment and creative problem-solving skills.