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.
Utility Management
- 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.
Project Management
- 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.
Single-Use Technology Support
- 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.
Continuous Improvement
- 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.
Experience:
- 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.
