As the Senior Manager, Facilities Engineering at the Carlsbad Gene Therapy and Viral Vector Manufacturing site, the successful candidate will be responsible for overseeing the facilities and utility systems that are required to produce high quality and compliant drug products and drug substances. The primary role will be to manage the Facilities Engineering team, interfacing with external auditors and maintaining department inspection readiness, managing timelines and working with site stakeholders to successfully deliver customer deliverables. He/she will work with the leadership team to identify and prioritize areas for improvement and encourage good change management practices for production of drug substance and drug products for gene therapy and oncology applications. The Sr. Manager, Facilities Engineering will actively communicate and work with multiple client groups at a variety of management levels within the organization forming alignment in business processes and strategies.
- Project management of facilities capital expenditure projects.
- Provide subject matter maintenance expertise to the network for utility systems and other mechanical systems.
- System ownership including maintenance of systems, CAD drawings, GMP change control, development of maintenance plans and oversight of system performance.
- Perform data extraction and analysis from the Computerized Maintenance Management System (CMMS).
- Work within GMP facilities including strong understanding of regulatory requirements related to facility systems in GMP areas.
- Identifies and implements process and safety improvements.
Who You Are:
- BS degree in Engineering, Construction Management, or other related technical/science/ engineering related field or GED with 10+ years of facilities biotech experience.
- 4+ years of experience in of Engineering/Facilities Management.
- 3+ years of working within an FDA-regulated medical device or pharmaceutical industry experience or GMP experience
- 3+ years of experience handling multiple projects, work proficiently and accurately while still completing projects on time.
- 3+ years of experience working with and understanding CAD drawings including single line and P&ID drawings
- 3+ years of experience working with Computerized Maintenance Management Systems
- PhD or Master's Degree in Engineering, Construction Management, or other related technical/science/ engineering related field with 4 years of Engineering/Facilities Management experience
- Experience with benchmarking
- Ability to translate and communicate detailed data analysis to all levels of the organization and staff with varying levels of knowledge and experience
- Excellent written and verbal communication skills as well as computer skills including, spreadsheet capability, Microsoft Excel, Word and data base management. SOP writing skills.
- Experience working with best practices for mechanical maintenance
- Experience of People Management