Manufacturing Technician I/II/III - Formulation & Component Prep 2nd Shift Only
Nashville, Tennessee
Operations – Manufacturing /
Full-Time /
On-site
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!
August Bioservices is hiring Filling/Manufacturing Associates at various position levels to work in the new aseptic manufacturing facility located in Nashville, TN. The Manufacturing Technician– Component Preparation and Formulation will operate a variety of processing and packaging equipment to prepare components for aseptic filling to include bulk formulation of aqueous and non-aqueous based products, order and receive components, dispense and formulate raw materials, manage sterilized components, operate various equipment used in the formulation process, and perform cleaning operations for process equipment and the GMP ISO 8 areas.
Responsibilities
- Operate processing equipment in accordance with SOPs, in classified areas.
- 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.
- Use proper aseptic technique while performing tasks to set up filling line equipment including; parts / terminal sterilizers, parts washing system, and other supporting component preparation systems
- Use proper technique while performing tasks to set up equipment including mixers, tanks, valves, etc.
- Actively participate in the completion of batch records, protocols, and all other GMP documents.
- Adhere to requirements for Good Documentation Practices (GDP) and cGMP requirements.
- Complete dispensing, formulation, filter integrity testing, sample submission, filling, and all other supporting processes per batch record documentation, procedures, protocols, etc.
- Break down compounding equipment for changeovers, clean and sanitize, set up
- Troubleshoot process equipment and interact with maintenance personnel.
- Demonstrate proficiency as outlined in training requirements for equipment systems and position.
- Recognize and report deviations or potential issues immediately to the management team.
- Perform manual packing.
- Ability to properly enter cleanrooms, maintain gown certification requirements, and demonstrate proper cleanroom environment behavior, including aseptic technique.
- Communicate and report status of equipment maintenance related issues to the area supervisor / manager and assist with actions necessary to resolve issues.
- Perform all job responsibilities in compliance with applicable EHS, GMP, SOP regulations, guidelines, and policies.
- All manufacturing team members are expected to support all production areas as needed for material movement/transfers, gowning and production supplies and cleaning/sanitization of all production areas.
Requirements
- BS or BA or equivalent in a biological, chemical science, engineering, or degree in another discipline
- One year or more of pharmaceutical experience preferred. In lieu of degree, candidates with sufficient technical depth achieved from a minimum of three years of professional experience in an aseptic manufacturing environment may be considered.
- Mechanical aptitude required to operate autoclaves, depyrogenation tunnels, and other component preparation equipment as well as mixers, pumps, balances, pH meters, and other formulation and compounding related equipment.
- Attention to detail and quality and a high level of integrity and confidentiality while completing multiple or repetitive tasks and meeting timelines and deadlines.
- Ability to read, understand, follow, and comply with technical and written documents (SOPs.)
- Ability to work around acids, bases, oxidizers and cleaning solvents while wearing appropriate PPE.
- Ability to perform calculations using simple mathematical formulas using fractions, percentages, and significant numbers. The ability to accurately measure volume and weight.
- Must be able to follow detailed processing instructions as well as clearly and accurately documenting all necessary batch documentation.
- Basic computer skills required.
- Ability to complete and maintain gowning requirements. Must be able to work while wearing full protective gowning required for GMP areas for an entire shift.
- 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; over-time 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.
