Somerville, Massachusetts
Facility Manager Job Opening in Somerville, Massachusetts - About Finch Therapeutics :
Finch Therapeutics is a drug discovery company aiming to unlock the therapeutic potential of the microbiome. We support human interventional studies that intentionally manipulate the microbiome to investigate causality in diseases that are otherwise poorly understood. We filter data from these studies through our machine learning platform to identify specific strains that drive clinical phenotypes of interest. Our team values transparency, integrity, humility, and collaboration, and we intend to have fun while maximizing our ability to make an impact on patients? lives. We are searching for passionate teammates eager to support this mission.
Job Description:
We are seeking a Facility Manager, with a demonstrated history of experience in GMP regulated manufacturing operations.
The Facility Manager, with guidance from the Director of Technical Operations, will support day to day manufacturing and lab operations by providing project management of construction and maintenance tasks under general guidance to ensure continued compliance to cGxPs.
Position Responsibilities / Duties:
Reports directly to Director of Technical Operations, provides hands-on leadership, oversight and execution of Facility/Equipment Operations. Dotted line reporting to the Vice President of Therapeutic Development.
Maintain a high level of personal compliance to the required standards.
Participate in facility design team meetings, provide visibility to senior management on progress and timelines. Manage general contractor and quality of build.
Manage facility construction and support contractors, including pest control, waste management, cleaners, fire systems, and HVAC.
Ensures effective and compliance operations in accordance with site registrations, GMPs and environmental regulations and state requirements.
Ensure that all facility utilities are 100% operational and maintained in support for Manufacturing, Quality Control, Fulfillment and Logistics, Product Development, and Research.
Resolve and repair facility support systems safely and expeditiously.
Recommend solutions and implements appropriate corrective actions for major and complex maintenance issues .
Startup and shutdown facility systems.
On board new equipment as required for Clinical Manufacturing and Product Science.
Manage plans for calibration and preventative maintenance of all GMP equipment, lab equipment, and utilities. Utilities to including compressed gases, HVAC systems, electrical, life safety, and emergency power system (UPS).
Organize and manage records keeping of preventative maintenance, calibration, facilities cleaning activities according to cGMP.
Responsible coordination of monitoring and responding to remote Critical Equipment Monitoring System notifications and take appropriate action per approved SOP?s.
Generate SOP?s, deviations, and change control as required for related Facilities systems.
Revise SOP?s as required for updated systems and procedures.
Manage cleaning supply inventories.
Develop annual Facilities budget .
Maintain up to date records for all state, federal, and local licenses and inspections and maintains systems in compliance with local and state regulatory bodies associated with waste water, sewer, emissions, waste handling/storage and disposal.
Effectively develops and leads site services with accountability for execution of site capital projects, process control automation, plant maintenance and site maintenance to enable Finch Therapeutics operations and other support functions to meet or exceed business expectations in cost, quality, compliance, safety, culture and capital.
Skills, Knowledge, Qualifications, and Experience:
Bachelor of Science in Engineering related field, or equivalent Science or Manufacturing Management related field, or a combination of education and industry experience.
Professional Engineer (PE) a plus.
Project Management Certification (PMP) a plus.
Direct experience working on large scale mechanical systems (HVAC/Refrigeration).
Cleanroom Design, Operation and Maintenance.
Knowledge with local and state regulatory requirements related to waste water, emissions, sewer systems, waste handling/storage and disposal.
7+ years of experience in a regulated environment, with 5+ years of Facility maintenance experience.
Strong technical writing skills.
Ability to work independently, with minimal supervision.
Physical demands and work environment: The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to gown and gain entry to manufacturing areas.
Ability to work in a manufacturing clean room for extended period of time.
Physical demands: While performing duties of job, employee is occasionally required to stand for extended periods of time as well as occasionally required to walk, sit, bend down/ crouch, use hands to handle or feel objects, tools, or controls; reach with hands and arms; talk and hear. Employee must occasionally lift and/or move up to 30 pounds.
Work environment: Work will be performed in both an office and laboratory/ manufacturing facility. The noise level in the office is low. The noise level in the laboratory/ manufacturing facility is moderate.
At Finch Therapeutics, you can expect to engage deeply in the core of our mission. You will grow with a dynamic, rapidly expanding organization, and have an opportunity to contribute to cutting edge research that will truly impact patients? lives. We offer a competitive starting salary, plus healthcare and other benefits. As we grow, there will be opportunities for professional development.
Application Instructions:
To apply, please go to /join-finch/, then follow the link for Quality Associate to submit your cover letter and resume. Promising candidates will be contacted to further evaluate their fit for this role and our organization.
Candidate must be legally eligible to work in the US. Work sponsorship for this role is not available now or at a future date.
Job Type: Full-time
Required education:
Bachelor's
Required experience:
experience in a regulated environment: 1 year
Facilities Management: 5 years
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