Senior Manager, Facilities & Engineering (Compliance Engineering)(25101-R-689-FAC)

About the position

Arsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We seek a talented and Senior Manager, Facilities & Engineering experienced to work onsite based in our Hayward office. ArsenalBio’s mission and purpose are very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy. Driven by a collective of diverse experts across multi-scientific disciplines and clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients’ lives. This means you’ll have the opportunity to work with the best talent in the field of cell therapy and be part of ONE TEAM, which advances therapies for patients who need it most. This role is a Subject Matter Expert (SME) with demonstrated advanced knowledge and understanding of implementation of Facilities’ systems and compliance within the biopharmaceutical GMP environment. This role is a key position at ArsenalBio and the successful candidate will significantly improve our ability to implement and continuously improve the facilities, maintenance, and calibration strategies for Arsenal’s GMP and Clinical manufacturing, warehouse, and offices. This is an exciting and dynamic opportunity for you to contribute to the development of new principles and concepts and to be challenged and lead change in having a facilities and engineering perspective. The individual will report directly to the Head of Facilities & Engineering. This role provides technical support to the manufacturing facility, including the design and specification of plant utilities, and building management platforms. The Associate Director will be part of a dynamic group of engineers who are responsible for capital and expense project delivery, equipment and utility troubleshooting, root cause analysis, and providing optimization strategies for process support equipment within multi-product, FDA regulated GMP facilities. The ideal candidate will lead a team of engineers with the mission to sustain GMP production equipment and drive various equipment development projects in support of ongoing cost reduction, quality enhancement, capacity creation, new product introductions, and / or product transfer initiatives. This leader is also responsible to establish and monitor the performance of work order, calibration, and preventive maintenance programs and drive continuous improvement of equipment metrics. Additionally, this leader will also be responsible for managing all F&E Quality records and ensuring on-time completion.

Responsibilities

• Establish GMP processes for asset management, work orders, calibration, and preventative maintenance
• Lead the implementations of BMS, EMS, and CMMS
• Ensure the F&E department is in compliance with all Quality processes and initiatives
• Provide leadership and supervision to various facilities department staff, contract staff and contracted equipment service providers supporting the F&E systems and functions
• Manage all F&E Quality records (Deviation, CAPA, Change Control, Risk Assessments, and Audit Reports) and ensure on-time closure through thorough well written documentation
• Serve as SME on Facility Engineering Design and Construction for laboratory and GMP manufacturing expansion projects within Facilities & Engineering, sharing best practices, technical know-how and adding significant value to the group
• Provide technical expertise to support process tech transfers and/or expense/capital projects through budget development, schedule development, resource planning, design, construction, commissioning and qualification activities
• Provide technical leadership to monitor physical plant health through system reliability analyses
• Participate in gap analyses and risk assessments to support process tech transfers
• Review and provide recommendations on design drawings, which may include PFDs that incorporate mass or energy balances and P&IDs, which include all line sizing, instrumentation and control philosophies
• Interact with vendors concerning contracts of critical financial value and select vendors based on key performance criteria
• Participate as technical expert in site regulatory inspections, as needed

Requirements

• BS/MS in engineering discipline
• 8+ years of applicable Facilities and Engineering experience and 5+ years of supervisory experience
• Project Management experience
• Advanced knowledge of Biologics Process Engineering Design and Construction
• Excellent communication skills, both written and verbal
• Experience in the selection and implementation of systems such as BMS, CMMS, and EMS
• Prior experience in cell therapy commercial GMP facility
• Validation experience related to equipment, utility and process systems, including requirements for documentation and testing
• Thorough knowledge of cGMP guidelines, experience in generation of controlled documents and extensive experience in equipment start-up and validation

Nice-to-haves

• PE licensure is preferred

Benefits

• Medical, dental, and vision insurance
• Mental health resources
• Virtual and telehealth options
• Coaching
• Infertility treatment
• Parental leave
• Health savings accounts
• Flexible work schedules
• Flexible time off including two extra 'Arsenal Days of Rest' every quarter