Quality Engineer
No salary listed
Senior
Bachelor's, Master's
Nashville, TN, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- A bachelor's or master's degree and at least five years of Quality Assurance experience in a biotechnology, biologics, or pharmaceutical manufacturing facility are required.
- A proven track record with CMC and technology transfer is required.
- Knowledge of Good Manufacturing Practice compliance is required, including 21 CFR 210, 211, 820, the PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (including Annex 1), and FDA Guidance on Aseptic Processing; Part 11 compliance knowledge is preferred.
- The ability to prioritize work efficiently and communicate project information quickly in a fast-paced environment is required.
- The role requires prolonged periods sitting at a desk and working on a computer, and the ability to lift up to 15 pounds at times.
Responsibilities
- Represent the Quality function in internal and external meetings for new client projects, determine deliverables and timelines, and communicate upcoming activities with Quality Assurance, Quality Control, and Validation.
- Support technology transfer of products and processes from clients into manufacturing and laboratories from the Quality perspective, across research and development, formulation development, clinical, and commercial manufacturing projects.
- Work cross-functionally with internal departments to transfer and maintain processes in the facility.
- Proactively identify CMC critical-path items, risks, and impediments to successful transfer, and develop solutions to mitigate them.
- Support projects that streamline new product introduction and provide feedback to the Change Review Board on change controls for introducing new products.
- Develop and implement phase-appropriate strategies for efficient transfers and identification of Quality deliverables.
- Work with Product Quality Assurance and Manufacturing to generate appropriate batch documentation.
- Communicate project status, upcoming deliverables, and timelines to the Quality Organization.
- Work with Manufacturing, Engineering, Supply Chain, and Commercial Operations to drive technical transfer of client products for manufacturing and laboratory testing.
- Collaborate with clients and internal cross-functional stakeholders to move projects forward.
- Support internal audits and regulatory inspections.
- Adhere to company policies and applicable regulatory agency requirements, including ICH and FDA requirements, to ensure compliance.
- Communicate clearly with cross-functional teams.
Desired Qualifications
- Part 11 compliance knowledge is preferred.
About the company
August Bioservices is a US-based CDMO offering end-to-end drug development and manufacturing from pre-clinical to commercial. It combines large-CDMO scale with a customer-focused hybrid model to serve startups and big pharma. It provides full development programs including research, development, testing, lab services, and sterile fill/finish under one integrated process, ensuring cGMP and FDA-quality standards. Its goal is to help clients bring safe, effective drugs to market efficiently through a seamless, integrated pathway.
Company Size
51-200
Company Stage
Series B
Total Funding
$88.6M
Headquarters
Nashville, Tennessee
Founded
2017
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Simplify's Take
What believers are saying
- Vial filling qualified in July 2026, unlocking throughput from the $60 million expansion.
- Series B funding in 2025 financed an additional high-speed vial suite and automation.
- August Bioservices' 2026 event calendar signals active business development across BIO, CPHI, and Contract Pharma.
What critics are saying
- Sterile injectable capacity takes roughly 30 months to qualify, delaying revenue from expansion.
- A single FDA contamination finding can halt lines, erase customer trust, and trigger recalls.
- Specialization in sterile injectables concentrates exposure if outsourcing demand shifts or major clients leave.
What makes August Bioservices unique
- Nashville campus offers sterile injectables, development, and manufacturing on one contiguous site.
- August Bio runs fully isolated vial, syringe, and IV bag lines with in-house analytics.
- The 2026 site integrates automated inspection, labeling, packaging, and serialization for faster releases.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Health Savings Account/Flexible Spending Account
- Unlimited Paid Time Off
- Flexible Work Hours
- Remote Work Options
- Paid Vacation
- Paid Sick Leave
- Paid Holidays