Sr. Validation Engineer
Company: August Bioservices
Location: Nashville
Posted on: February 16, 2026
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Job Description:
Job Description Job 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 looking for a Sr Validation Engineer team member
that is passionate and driven regarding their work. August
Bioservices needs a motivated individual to provide their expertise
in the delivery of results for the company and its clients.
Reporting to the Director of Validation and Metrology, the Sr
Validation Engineer will be responsible for performing validation
related tasks for the Nashville site. The Sr. Validation Engineer
independently performs validation tasks to serve company and
customer needs and to follow cGMPs. Responsibilities Prepares
validation protocols (IQ/OQ/PQ) and final reports for equipment and
processes to assure they are in compliance with Code of federal
regulations, (CFR), International Society for Pharmaceuticals
Engineering (ISPE), and Aseptic Processing Guidance. Will prepare
and or review the User Requirement specifications, System Impact
assessments, Design Specifications, Enhanced design reviews, and 21
CFR assessments. Will be the validation lead for major site
validation projects such as: equipment cleaning, cleanroom
qualification, sterilizers, automated filling machines, utilities,
WFI, and clean steam, Will participate in Factory Acceptance
testing and Site Acceptance testing, Oversees and executes
validation and re-validation studies Develops validation acceptance
criteria Represents validation in agency and customer audits as an
SME. Writes and revises, validation master plans, work
instructions, and Standard Operating Procedures (SOPs);. Recommends
validation procedural and test improvements Maintain current
validation project schedules Provide training for both team
validation members and contract validation personnel Review
critical equipment drawings from a Validation perspective Review
and summarize equipment history files to assess the validated state
of equipment Proactively identifies potential obstacles to
successful project completion. Establishes remediation plans to
overcome these obstacles; and Participates as validation
representative on failure investigation teams Requirements BS in
Biology, Biochemistry, Biotechnology, Microbiology, Chemical
Engineering, Mechanical Engineering, Pharmaceutical Engineering or
other related discipline 5 years of experience with BS in
Pharmaceutical, Biological or Biotech industry; hands-on experience
in manufacturing operations or pilot lab / scale-up operations
Excellent verbal and written communication skills 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. We may use artificial intelligence
(AI) tools to support parts of the hiring process, such as
reviewing applications, analyzing resumes, or assessing responses.
These tools assist our recruitment team but do not replace human
judgment. Final hiring decisions are ultimately made by humans. If
you would like more information about how your data is processed,
please contact us.
Keywords: August Bioservices, Clarksville , Sr. Validation Engineer, Engineering , Nashville, Tennessee
