Job Details
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). 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 Manufacturing Operator I - Equipment Prep, will clean, assemble, wrap, and sterilize equipment, filter assemblies and tools for the formulation and filling operations. Equipment and material transfer throughout the classified cleanrooms is required to support all production operations. Operators will be responsible for maintaining the cleanroom environment, instruments and the stocking of supplies and gowning materials. Sanitizations of instruments, equipment and all GMP classified areas is required to maintain a low bioburden control.
Responsibilities
- Operate processing equipment in accordance with SOPs, in classified areas following GMP and GDP principles.
- Use proper aseptic technique while performing all GMP activities, without compromising aseptic conditions while working in Grade B/C/D/CNC environments.
- Cleaning equipment pre-use and post-use, utilizing semi-automated, automated, and manual processes.
- Pre-use and post-use integrity testing of filters.
- Assembly of equipment to be used in aseptic formulation and filling operations.
- Wrapping of parts, equipment and filter assemblies and tools in preparation for sterilization
- Loading, operating, and unloading of the autoclaves.
- Loading and unloading of HEPA transfer cabinet.
- Support the loading and unloading of terminal sterilization autoclave.
- Transfer of materials using proper sanitization processes pes SOPs.
- Perform material transfer sanitization per SOPs.
- Perform cleanroom and equipment sanitizations per SOPs.
- Actively participate in the completion of batch records, protocols, and all other GMP documents, following Good Documentation Practices (GDP).
- Actively participate in troubleshooting processes and equipment problems as well as assisting the manager in completing all necessary paperwork associated with investigations, deviations, and remarks.
- Demonstrate proficiency as outlined in training requirements for equipment systems and position.
- Recognize and report deviations or potential issues immediately to the management team.
- Communicate and report status of equipment maintenance related issues to the area leadership and assist with actions necessary to resolve issues.
- Perform all job responsibilities in compliance with applicable EHS, GMP, SOP regulations, guidelines, and policies.
- Participate in training related to all sub-departments within the Manufacturing Department, to include material transfer, cleaning/sanitization, formulation, equipment preparation, filling, sterilization, inspection, and packaging.
- Periodically take on other responsibilities in support of all Manufacturing activities as needed to support the business
Requirements
- At least 1 year of experience in a manufacturing or highly regulated production environment.
- High School Diploma or equivalent
- Physical requirements include stooping, standing, climbing, and lifting between 30 - 50 lbs.
- Ability to establish and maintain working relationships cross functionally including production, QA, QC, engineering, validation, and maintenance.
- The ability to communicate effectively, both verbally and in writing, to all levels within the organization.
- Position may require employees to work in a 24/7 rotational schedule. This schedule will include holidays, and weekends; overtime may be required. Work closely with shift team to achieve goals in a 24/7 cGMP Production Environment
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.