August Bioservices, LLC · 1 day ago
Technical Writer, Technical Operations
Nashville, Tennessee
Full-time
Onsite
Entry Level
2+ years expAugust Bioservices is a company focused on pharmaceutical drug products, and they are seeking a Technical Writer for their Technical Operations department. The role involves coordinating and completing technical documentation, supporting R&D Scientists and Technology Transfer Engineers, and ensuring compliance with cGMP standards.
BiotechnologyMedicalPharmaceutical
Responsibilities
Revision/creation of SOP’s Master Batch Records, Summary reports, Protocols, etc. based on technical information provided by internal SME’s (process flow diagrams, client batch records/protocols, data summaries etc…)
Tracking assigned Change Controls, CAPA’s, Issue Reviews etc. open tasks and collaborate with internal and external stakeholders to manage due dates and required input
Evaluation of client provided documents, internal/external reports and feedback to properly inform internal document creation and revision
Work closely with the Quality Assurance team to maintain current templates for documents based on documentation and compliance best practices
Support continuous improvement efforts to revise all document templates as required
Support issuance of change controls in Master Control e-QMS for introduction of new processes and changes to existing processes
Work in conjunction with area owners to ensure document design meets internal and external expectations
Management of multiple projects and concurrent timelines while adhering to standard timelines, and escalating actions appropriately for resolution in a timely manner
Support active project execution as required in support of R&D Scientists and Technology Transfer Engineers
Qualification
Required
2+ years work experience in a pharmaceutical or life science related field
Proficiency with technical writing in cGMP or FDA regulated manufacturing environment
Ability to work in a fast-paced environment and manage multiple projects and objectives for on-time event closure
Understanding of aseptic manufacturing processes
Able to be proactive, action-oriented, and adapt to change
Able to identify and flag risks in a timely manner to keep deliverables on track
Strong written and verbal communication skills
Ability to read and comprehend complex subjects related to pharmaceutical manufacturing
Ability to document complex ideas in way that others can easily understand
Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint), and familiarity with cGMP quality systems
Ability to understand and apply GMP regulations as they relate to pharmaceutical manufacturing
Duties will require work on multiple shifts, including nights and weekends on occasion
Ability to wear protective gear (e.g., gowns, gloves, face masks) required to enter our cleanrooms and production spaces
Ability to stand for long hours at a time to observe production as needed
Preferred
Bachelor's degree in science, technology, or related field preferred
Company
August Bioservices, LLC
August Bioservices, a leading sterile injectable CDMO headquartered in Nashville, Tennessee, delivers end-to-end contract development and manufacturing services for pharmaceutical and biotech clients.
51-200 employees
H1B Sponsorship
August Bioservices, LLC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (15)
2024 (11)
2023 (12)
2022 (2)
2021 (4)
Funding
Current Stage
Growth StageTotal Funding
$88.6MKey Investors
Oak HC/FTPolaris Partners
2022-12-01Series B· $65M
2021-05-27Series A· $23.6M
2020-07-16Series Unknown
Leadership Team
Mats Bjoerkman
Chief Financial Officer
Colette Lanzon
Talent Acquisition Business Partner
Recent News
Seattle TechFlash
2025-06-24
The Business Journals
2024-02-11
Company data provided by crunchbase