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Jobs at August Bioservices, LLC (Now Hiring) — 2 open

August Bioservices, LLC logoAugust Bioservices, LLC

Validation Supervisor

Nashville, Tennessee, United States · On-site

Senior$89M raised

Reporting to the Senior Director of Validation and Metrology, the Validation Supervisor will be responsible for providing leadership and guidance in validation-related tasks to the validation team with up to 5 direct rep…

Skills: Validation Leadership, cGMP Compliance, Validation Master Plans, IOQ/PQ Protocols, SOP Writing

August Bioservices, LLC logoAugust Bioservices, LLC

People Operations Coordinator

Nashville, Tennessee, United States · On-site

Entry level$89M raised

The People Operations Coordinator is a critical hire on our growing People team. This role will play a critical part in employee experience, owning our onboarding program end-to-end, keeping our HR operations running smo…

Skills: Onboarding, HR Operations, Talent Acquisition, Payroll Administration, Benefits Administration

August Bioservices, LLC logo

Validation Supervisor

August Bioservices, LLC

Nashville, Tennessee, United States • On-site

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Senior

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  • Full-time
  • bachelor degree
  • Posted 10d ago
  • ~40 hrs/week

Responsibilities

The Validation Supervisor leads a team of direct reports in executing validation tasks and managing project schedules to ensure cGMP compliance. They are responsible for developing Validation Master Plans, writing protocols, and serving as a subject-matter expert during agency and customer audits.

Requirements

Candidates must possess a Bachelor's degree in Biology, Biochemistry, Microbiology, or Chemical Engineering. A minimum of 6 years of validation experience in the pharmaceutical or biotech industry, along with team management or mentoring experience, is required.

Full job description

Reporting to the Senior Director of Validation and Metrology, the Validation Supervisor will be responsible for providing leadership and guidance in validation-related tasks to the validation team with up to 5 direct reports.  The Supervisor independently directs and performs validation tasks to meet customer needs and comply with cGMPs.  The supervisor will manage validation projects and serve on validation project committees.  Develop Validation Master Plans and provide guidance for best validation practices.  The supervisor will also represent the Validation Department on interdisciplinary facility teams and client meetings/visits.  The Supervisor will be considered a subject-matter expert in certain validation methods and practices and will represent August Bio in both agency and customer audits. 

\nResponsibilities
  • Maintain the validation team project schedule.
  • Tracks the progress and success of their direct reports.
  • Helps to develop goals for direct reports.
  • Write Validation Master plans and all other validation protocols, including IOQ’s, PQ’s, final reports, and SOPs.
  • Manage the qualification and re-qualification schedule.
  • Provide reviews and oversight to validation reports and periodic reviews.
  • Provide training for both internal and contract personnel.
  • Proactively identifies potential obstacles to successful project completion and helps establish remediation for them.
  • Develops Validation acceptance criteria.
  • Provides leadership in the field and executes validations in the field.
  • Provides acceptance criteria based on agency guidelines and best practices.
  • Recommends validation procedural and test improvements.
  • Review equipment drawings and facility P&IDs from a validation perspective.
  • Manages resource support for validation projects
  • Schedule and chair interdepartmental project meetings
  • Participates as a validation representative on failure investigation teams.
  • Represent August Bio as validation SME for agency and customer audits
Qualifications
  • Excellent verbal and written communication skills
  • BS in Biology, Biochemistry, Microbiology, or Chemical Engineering
  • 6+ years of Validation experience in  Pharmaceutical, Biological or Biotech industry
  • Experience managing a team, or significant experience coaching and mentoring team members
\n

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Prolonged periods sitting at a desk and working on a computer.
  • Must be able to lift up to 50 pounds at times, and up to 30 pounds frequently.

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.

Related keywords

ValidationMetrologycGMPValidation Master PlanIOQPQSOPPharmaceuticalBiotechBiologicalsEquipment QualificationP&IDAuditSMEFailure Investigation

About August Bioservices, LLC

LinkedInVisit site

Sterile Injectable CDMO

Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2020
Headquarters
Nashville, Tennessee
LinkedIn followers
13,315
Total funding
$89M

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. Specializing in sterile injectable solutions, August Bio is an expert in aseptic and terminally sterilized filling for vials, syringes, and flexible IV bags. With support spanning from formulation development to commercial production, August Bio stands out as a reliable partner. Following two major expansions and a complete renovation, the company is equipped with state-of-the-art technology and a team backed by decades of industry experience

Offices: 1845 Elm Hill Pike, Nashville, Tennessee 37210, US

Preclinical Trial Material ManufacturingFormulation DevelopmentMicrobiologyAnalytical ChemistryProcess DevelopmentStability ProgramsSterile Injectable ManufacturingAseptic FillingE&L TestingCommercial Manufacturing
View all jobs at August Bioservices, LLC

About August Bioservices, LLC

LinkedInVisit site

Sterile Injectable CDMO

Industry
Pharmaceutical Manufacturing
Company size
51-200 employees
Founded
2020
Headquarters
Nashville, Tennessee
LinkedIn followers
13,315
Total funding
$89M

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. Specializing in sterile injectable solutions, August Bio is an expert in aseptic and terminally sterilized filling for vials, syringes, and flexible IV bags. With support spanning from formulation development to commercial production, August Bio stands out as a reliable partner. Following two major expansions and a complete renovation, the company is equipped with state-of-the-art technology and a team backed by decades of industry experience

Offices: 1845 Elm Hill Pike, Nashville, Tennessee 37210, US

Preclinical Trial Material ManufacturingFormulation DevelopmentMicrobiologyAnalytical ChemistryProcess DevelopmentStability ProgramsSterile Injectable ManufacturingAseptic FillingE&L TestingCommercial Manufacturing
View all jobs at August Bioservices, LLC

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