Senior Manager, Facilities Maintenance
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
About Astellas Gene Therapies
Astellas Gene Therapies is an Astellas Center of Excellence developing genetic medicines for patients with rare, life-threatening diseases. Based on our innovative approach to developing genetic medicines, as well as our industry-leading internal manufacturing capability and expertise, we have become the Astellas Center of Excellence for their newly-created Genetic Regulation Focus Area. We are currently exploring three gene therapy modalities: gene replacement, exon skipping gene therapy, and vectorized RNA knockdown, with plans to expand our focus and geographic reach under Astellas. We are based in San Francisco, with manufacturing and laboratory facilities in South San Francisco and Sanford, North Carolina. For more information, please visit our website: www.astellasgenetherapies.com.
The Senior Manager, Facilities Maintenance will lead the Facilities maintenance Department's efforts in operating and maintaining the utilities system, warehouse, manufacturing, & QC laboratory equipment. He/she is responsible to ensure proper operation of utility system, manufacturing equipment and auxiliary system to meet production plan. This role also trains and oversees in-house technicians and third party service vendors to provide qualified services meeting AGT and GMP compliance requirement.
Job Responsibilities:
Manages and supervises the activities of the Facilities Maintenance staffs and third-party service vendors to maintain a reliable, secure, and compliant site
Ensure all facility utilities system (e.g. HVAC, chiller, boiler, CTW, cold chain, autoclave, compressed gas system, waste treatment system, fire life safety equipment…) are in operation properly and well maintained. Serve as SME to troubleshoot issues.
Delivers input on capital projects to upgrade or expand facilities and equipment needed; assists in planning, execution, and documentation
Ensures compliance of the site and of facilities’ operations relative to applicable US and international regulatory agencies including OSHA and FDA
Manages and coaches maintenance staffs to well maintain and troubleshoot site equipment issues
Coordinates facility shutdowns to ensure all PM's and repairs are completed in a timely manner and completing all necessary documentation
Guarantees that department resources are available to promptly respond to and resolve Facility problems
Oversees third party facilities’ service provider relationships by: maintaining a master contact list; having appropriate service agreements in place; guaranteeing vendors are appropriately trained and qualified; establishing and maintaining accounts; coordinating services; reviewing work reports
Oversees third party service provider to ensure the site is in compliance in GMP or non-GMP cleaning throughout the site. Ensure all the cleaning crew members who performing GMP cleaning are trained and follow SOP/WI to perform all GMP activities
Supports timely closure of facility related cGMP deficiencies including audit observations, corrective, and preventative actions (CAPA) and deviations
Develops and maintains a spare parts program that supports manufacturing and minimizes down time
Assists in establishing KPI's, including staying within the budget, ensures staff support to meet KPI's as a set forth by the Site Leadership Team, and takes corrective actions to mitigate performance gaps
Possesses knowledge of electrical circuitry, process controls, PLCs, EMS and BMS
Demonstrates a high commitment to safety in actions
Starts, stops, and operates all equipment, including loop check, tune, and troubleshoot instrumentation
Participates in the development, loading, ownership and maintenance of a new CMMS system (BM-RAM, extension of existing instance)
Creates/maintains job plans (routine PM, planned and non-planned repairs), orders necessary equipment for repairs, coordinates equipment availability, and manages the CMMS for instrumentation equipment
Maintains records for maintenance work orders and testing data/report
Drafts, reviews, approves all facilities related SOP's, policy documents, or other related documentation
Work in a team environment and emphasize healthy customer service
The Senior Manager will be responsible for managing maintenance, troubleshooting, and repair on a variety of equipment via both direct performance and through third party service vendors to decrease downtime with processes and systems. The role will be accountable for the training, screening, and set up in house technicians or third-party service vendors to ensure a successful ongoing relationship.
The Senior Manager, Facilities Maintenance will report to the Associate Director of Facilities, Utilities and Engineering. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas Gene Therapies and the Astellas organization. Under this role will be Facilities Maintenance Supervisors in shift that they lead their own group of maintenance technicians.
Required Qualifications:
Bachelor's Degree in science, technology or engineering discipline and 8+ years of Engineering/Facilities Management experience (3+ years within a GMP manufacturing operations environment)
Associate degree and 10+ years of Engineering/Facilities Management experience (3+ years within a GMP manufacturing operations environment)
5+ years of supervisory experience
Strong knowledge of facilities/utilities equipment (e.g. HVAC, chiller, boiler, CTW, cold chain, autoclave, compressed gas system, waste treatment system, fire life safety system…)
Experience in vendor management and managing outsource service providers.
Technical knowledge in drug substance and drug product process equipment maintenance
Able to lead root cause investigation for process failure and/or deviation.
Experience with CMMS, ideally BM-RAM.
Capable to read and understand piping & instrumentation diagram
Ability to build working relationships and effectively partner cross-functionally, cross-regionally and at all levels in the organization.
Must be familiar with Microsoft Office applications.
Detail oriented with excellent oral and written communication, facilitation, organizational and planning skills. Strong presentation, and facilitation skills.
Ability to represent organization to all management levels.
Proactive, self-starter with the ability to take on several projects at one time.
Completed work is reviewed from a long-term perspective for desired results.
Proven ability to lead diverse teams with strong leadership, development, and teamwork skills. An individual that has built and retained effective teams across multiple levels of the organization with direction to team based on organizational objectives and corporate policies and procedures.
Works closely with team and other functional key stakeholders on the Astellas AGT Technical Operations team to execute work and will be expected to perform other duties and/or special projects as assigned
Dependable and exhibits regular and predictable attendance and the flexibility to work various shifts
Preferred
Bachelor degree in Mechanical/Chemical/Electrical engineering discipline
Strong equipment troubleshooting skills
Expert knowledge of CMMS and asset life cycle management
Knowledge of data integrity requirement, EDMS and QMS applications
Experience with audit support/preparation
Working Conditions
This role frequently requires long periods of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting up to 20lbs.
This is an on-site role working in a cGMP regulated manufacturing facility.
On occasion, this role may travel to other Astellas Gene Therapies manufacturing facilities (0-5%)
Salary Range: $129,800 - $173,000 (NOTE: Final salary could be more or less, based on experience)
Benefits:
Medical, Dental and Vision Insurance
Generous Paid Time Off options, including Vacation, Sick time, plus national holidays including Heritage Days, and Summer and Winter Breaks
401(k) match and annual company contribution
Company paid life insurance
Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions
Long Term Incentive Plan for eligible positions
Referral bonus program
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability
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Category South San Francisco TC
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans