Nashville, TN, USA
August Bioservices
Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO) and Contract Research Organization (CRO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
The Facilities and Maintenance Supervisor is responsible for overall maintenance of August Bioservices facility and equipment. This includes preventative maintenance, work order execution, maintenance tasks and non-routine repairs to facility, utility support systems and manufacturing equipment. This role has overall responsibility for management and supervision of all supporting services required to properly maintain a state of operations readiness for our sterile drug manufacturing facility. This includes the utility area, warehouse and manufacturing areas and grounds and exterior of the building. The Supervisor will oversee activities of the individuals responsible for all maintenance activities and ensure the highest quality standards and regulatory compliance are maintained. This role maintains long-term and weekly scheduling of facilities related work, all site permitting provides compliant record keeping. The Supervisor assures uninterrupted operation of the facility with preventive plans for major utilities and associated systems. Predicts and/or corrects mechanical & electrical breakdowns following strict product safety & quality standards. Must have the ability & initiative to lead & participate in plant problem-solving, ability to apply problem-solving techniques, communicate efficiently, demonstrate leadership & plan effectively. Interested individuals must be able to work in a fast paced, multifaceted environment & work well in a team-based environment with limited oversight.
Responsibilities
- Oversee work activities involved in facilities maintenance, janitorial, pest control, landscaping, security, and any other service required to maintain the facility in good state and meeting regulatory requirements.
- Troubleshoot and resolve issues within a pharmaceutical manufacturing environment including Processing equipment for sterile filling
- Maintain and troubleshoot key systems for sterile processing including:
- Boiler / Chiller Systems
- HVAC including ISO 5 / ISO 8 and Lab Environments
- LN2 Refrigeration
- Reverse Osmosis w/ EDI Purified Water System
- Water For Injection / Clean Steam Generation and Distribution
- Point of Use WFI Cooling Systems
- Operation of BMS/EMS system with Alarm Reporting and Resolution
- Oversee PM Program and provide required documentation and reporting.
- Manage open work orders and provide required documentation and reporting.
- Ensure all information is entered into Master Control to track utilization and feedback is given on all work completed.
- Available for shift work & weekend work when periodically needed due to site projects and objectives.
- Serve as SME for facility and grounds maintenance expertise during customer or regulatory agency related audits.
- Partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations.
- Ensure that processes are in cGMP compliance and establish systems that identify opportunities to improve process effectiveness and heighten quality.
- Demonstrate understanding of relevant regulatory requirements.
Requirements
- 5+ years of facility engineering and/ or facility management .expertise, preferably in a sterile pharmaceutical manufacturing environment or similar FDA regulated environment.
- Bachelor’s Degree in relevant field, or equivalent facility certification, or significant work experience in lieu of a degree required
- Practical knowledge and application of cGMP and FDA, EMA regulations.
- Experience in developing facilities and engineering management programs for a major site.
- Demonstrated track record in safety.
- Experience coaching, developing, and managing a staff of professional employees as well as contractors.
- Experience managing and negotiating with contracting facilities services for manufacturing and commercial setting highly desired.
- Preferred Expertise in implementing lean six sigma, continuous improvements, and best practices culture.
- Exhibit a continuous improvement mindset with attention to details and the ability to train and influence peers.
- Ability to make sound decisions when faced with competing priorities.
- Excellent verbal and written communication skills.
- Must be detail oriented.
- Must be knowledgeable in Microsoft Office products.
At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.
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