Leverage experience in facility management to bring operational efficiencies and excellence to OrganaBio’s manufacturing facility and to ensure the facility and support laboratories are operating in a functional and compliant manner, as stated in applicable FDA, state and other applicable regulations and standards. Manage team to ensure that all work is completed efficiently and of high quality.
Essential Functions:
· Manage asset/equipment lifecycle including, but not limited to selection, purchasing, receiving, installation, qualification, repair, preventive maintenance, and cleaning.
· Manage Facility systems / equipment lifecycles including, but not limited to qualification, repair, and preventative maintenance.
· Maintain the Facility and equipment within in good working order and ready for possible inspections, as required by applicable regulations.
· Support and clear understanding of a comprehensive environmental monitoring program in support of the cGMP Facility, equipment that provides critical work areas, and support areas, as applicable.
· Maintain equipment, preventive maintenance, and cleaning documentation for clean room, according to the GMP/GLP documentation practices.
· Maintain and update Asset Master Files and equipment Management Database, throughout the lifecycle of equipment that supports the operations within the facility, including but not limited to new asset induction, installation, calibration / qualification / validation, preventive maintenance and decommissioning.
· Determine the capability of the general laboratory areas and cGMP facility clean rooms to provide the necessary support for new equipment (e.g., size, environmental temperature/humidity range, power requirements, and other utilities), and advise on renovations/modifications required to support new equipment acquisition and problem-free operation.
· Coordinate, oversee and/or manage repair and regular preventative maintenance work assignments performed by previously approved 3rd party vendors and contractors performing building maintenance, equipment maintenance, landscaping and janitorial work, and review work orders to ensure that assignments are completed according to the pre-established schedule.
· Obtain, review, and negotiate price quotes from vendors for new equipment, parts, services, preventive maintenance and labor.
· Forge and maintain vendor relationships and train vendors on work order, billing procedures and relevant documentation of service, as described in applicable regulations.
· Assist VP, Manufacturing in determining whether the facility has the ability to support new or specialized client and project-specific equipment (e.g., size, environmental temperature/humidity range, power requirements, and other utilities) and manufacturing activities.
· Support new clients with all aspects of move-in and utilization of the facility, including day-to-day operations and troubleshooting, as needed.
· Ensure established Standard Operating Procedures are followed to maintain equipment, automated systems and facility systems. Author new SOPs and initiate necessary SOP revisions as it becomes necessary.
· Actively promote safety protocols and awareness. Always demonstrate good safety practices, including appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
· With the support of company IT team, automate systems to include, but not limited to asset and facility management.
· Support internal and external facility inspections and audits.
Team Management
· Supervise Facilities Technician and Metrology Technician positions and assure that all assigned duties are completed on time, and the work performed is of high quality, and meets company standards and applicable regulations.
· Create and lead a culture/environment of inclusion by exemplifying inclusive behaviors, promoting the interaction and integration of diverse individuals into teams to positively impact the company.
· Anticipate changing circumstances and prepare function/department to maintain performance objective; promote a culture of positivity, continuous improvement, and adaptability/flexibility.
· Accomplish financial objectives by forecasting requirements, managing budget, analyzing variances, and initiating corrective actions.
· Optimize workplace productivity and promote professional growth through hiring, training, motivating, and directing employees.
OrganaBio is an Equal Employment Opportunity employer. OrganaBio prohibits any form of unlawful harassment or discrimination against applicants for employment or employees on the basis of any legally protected status entitled to protection under federal, state, or local law.
DISABILITY ACCOMMODATION FOR EMPLOYMENT APPLICATIONS OrganaBio is committed to providing reasonable accommodations to enable applicants with disabilities to have equal opportunity to search for a job opening or apply for a position. Any applicant requiring assistance with our career opportunities website or who needs an accommodation due to a disability, should send an e-mail to [email protected] This email address is not for general employment inquiries or correspondence. We may only respond to those requests that are related to the accessibility of the online application system due to a disability.
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.