- 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; vial / syringe fillers, lyophilizer loading system, capper and tray loader, parts / terminal sterilizers
- Perform manipulations via glove ports in the filling isolator (ISO 5) to include: set up of filling line, routine aseptic interventions (pulling of samples, EM monitoring & clearing downed vials / syringes), non-routine aseptic interventions (filler setup, needle changeout), operating filling and auto loading equipment using automated control systems; perform automatic weight checks; assist with and performs all interventions without compromising aseptic environment.
- Break down of filling line equipment for changeovers, clean and sanitize, set up RABS for next fill
- Actively participate in the completion of batch records, protocols, and all other GMP documents, following Good Documentation Practices (GDP).
- Troubleshoot process equipment and interact with maintenance personnel.
- Demonstrate proficiency as outlined in training requirements for equipment systems and position.
- Responsible for loading and unloading materials, labeling according to SOPs, assembling valves, connectors, and other equipment and tools using Aseptic technique.
- Recognize and report deviations or potential issues immediately to the management team.
- Perform manual packing.
- 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.
- 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 pumps, tanks, filling equipment, lyophilization equipment, and terminal sterilizing 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 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.
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Manufacturing Technician I/II/III - Nashville, United States - August Bioservices
Description
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 - Filling, Lyophilization, and Terminal Sterilization will use proper aseptic technique while performing tasks in aseptic manufacturing areas to include syringe and vial filling operations with an automated line in an RABS environment as well as routine and non-routine aseptic interventions through RABS glove ports.
The technician II level will operate filling and auto loading equipment, and freeze dryers using automated control systems.The Technician will be responsible for unloading of autoclaves, performing cleaning operations for process equipment and the GMP ISO 8 areas, management of sterilized components, and coordinating with maintenance as needed.
ResponsibilitiesWe 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 teamAugust 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.
