Responsibilities:

Facility Operations and Maintenance

Coordinate day-to-day operations of the facility, ensuring all infrastructure and utilities (HVAC, purified water systems, cleanrooms, etc.) meet operational requirements.
Perform routine maintenance, inspections, and troubleshooting of facility systems to ensure efficient performance and compliance with industry standards.
Support the installation, qualification, and validation of equipment and systems used in single-use biomanufacturing.
Develop and implement preventive and predictive maintenance programs to minimize downtime and operational disruptions.

Regulatory Compliance and Safety

Ensure facility operations adhere to cGMP, OSHA, and other regulatory requirements.
Conduct risk assessments and ensure compliance with environmental, health, and safety (EHS) standards.
Maintain comprehensive documentation for audits, including maintenance logs, calibration records, and operational procedures.
Support the preparation and execution of internal and external inspections and audits.

Manage critical utilities supporting the bioprocess design center, including steam systems, water purification systems, and air handling units.
Monitor utility performance and implement measures to optimize energy efficiency and sustainability.
Troubleshoot utility-related issues and coordinate repairs or upgrades with contractors and vendors.

Lead facility improvement projects, including upgrades, expansions, and new system installations, to support evolving biomanufacturing needs.
Develop project plans, timelines, and budgets, ensuring completion within scope and schedule.
Collaborate with external vendors and contractors to procure and install equipment and materials as needed.

Support the integration and operation of single-use systems within the facility, including bioreactors, filtration systems, and storage solutions.
Ensure facility infrastructure is compatible with single-use technologies and flexible for future process changes.
Collaborate with process development teams to address facility-related challenges associated with single-use biomanufacturing.

Identify and implement innovative solutions to improve facility performance, reduce operational costs, and promote sustainability.
Stay updated on the latest technologies and standard methodologies in facility engineering and biomanufacturing.
Propose and complete projects that improve efficiency and reliability in facility operations.

Bachelor's or master's degree in mechanical engineering, Electrical Engineering, Facilities Management, or a related field.
3+ years of experience in facility engineering or operations, preferably in the biopharmaceutical, biotechnology, or healthcare industries.
Familiarity with single-use technologies and bioprocessing systems is highly desirable.
Experience with cGMP facilities, cleanroom operations, and critical utility management.
Strong knowledge of HVAC, purified water systems, cleanroom operations, and facility management systems.
Proficiency with CMMS (Computerized Maintenance Management Systems) and facility monitoring tools.
Strong analytical and problem-solving skills with a hands-on approach to troubleshooting.
Excellent organizational and project management skills with the ability to handle numerous responsibilities.
Effective communication and collaboration skills to work with cross-functional teams and external vendors.
Certification in facility management (e.g., CFM, PMP) is a plus.
Knowledge of automation systems, Building Management Systems (BMS), and environmental monitoring systems.
Experience in sustainability initiatives, energy management, and green building practices.