Senior Validation Engineer at August Bioservices – Nashville, Tennessee
August Bioservices
Nashville, Tennessee, 37201, United States
Posted on
NewJob Function:Engineering
New job! Apply early to increase your chances of getting hired.
Explore Related Opportunities
Industrial Engineers, Including Health and Safety jobs in TennesseeJobs in TennesseeIndustrial Engineers, Including Health and Safety jobs
About This Position
Senior Validation Engineer
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!
Job title: Senior Validation Engineer
Work site location: 1845 Elm Hill Pike Nashville, TN 37210
Job description: The Sr. Validation Engineer will be responsible for leading validation related tasks for the Nashville site. The Senior Validation Engineer independently directs and performs validation tasks to serve customer needs and maintain compliance with cGMPs. Manages validation projects, develops Validation Master Plans, Protocols and Final Reports. Represents Validation Department on interdisciplinary facility teams.
Essential Duties and Responsibilities:
- Independently prepares validation protocols (IQ/OQ/PQ) and final reports, Validation
- Master Plans, and Master Plan Summary Reports for equipment and processes;
- Oversees validation and revalidation studies for protocol compliance;
- Develops validation acceptance criteria;
- Performs validation fieldwork on an as-needed basis;
- Writes and revises Standard Operating Procedures (SOPs);
- Recommends validation procedural and test improvements;
- Plan, track, and perform validation projects;
- Maintain current validation project schedules;
- Provide training for contract validation personnel;
- Review critical equipment drawings from a Validation perspective;
- Review and summarize equipment history files to assess the validated state of equipment;
- Manages validation projects, to include drawing on necessary resources to successfully
- complete validation projects within established timelines;
- Provide validation training/education on an as needed basis to project team members;
- Proactively identifies potential obstacles to successful project completion. Establishes remediation plans
- to overcome these obstacles; and
- Participates as validation representative on failure investigation teams.
- Provide Validation Subject Matter Expertise for the organization
Minimum requirements for the role:
- Seven (7) years of experience in pharmaceutical validation and qualifications;
- Seven (7) years of experience in aseptic sterile injectable pharmaceutical manufacturing involving validation, qualification, and lifecycle management of equipment, utilities, and processes in cGMP-regulated environments;
- Hands-on expertise in commissioning, qualification, and validation (IQ/OQ/PQ) of process equipment used for sterile injectable manufacturing process;
- Experience with Isolators, VPHP decontamination systems, autoclaves, depyrogenation tunnels, and sterile filling lines;
- Proven experience in VPHP cycle development, dwell time optimization, and BI challenge mapping for isolator decontamination systems;
- Knowledge of FDA 21 CFR Parts 210/211, EU Annex 1 (2023), ISPE Baseline Guide Vol 5 (2023 C&Q), and ICH Q9/Q10 principles;
- Experience in process validation (PPQ, CPV) and cleaning validation for sterile injectable facilities;
- Proficiency in developing and authoring Validation Master Plans, Risk Assessments (FMEA, SIA, FRA), and Discrepancy Reports/CAPAs;
- Demonstrated capability to lead cross-functional validation projects and support regulatory inspections (FDA, EMA) as site subject-matter expert (SME); and
- Experience with Validation Data Management (Kaye Validator) E QMS systems (Master Control, Blue Mountain, or equivalent).
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.
Scan to Apply
Just scan this QR code to apply from your phone.
Job Location
Nashville, Tennessee, 37201, United States
Frequently asked questions about this position
Continue to apply
Enter your email to continue. You’ll be redirected to the employer’s application.By clicking Continue, you understand and agree to JobTarget's Terms of Service and Privacy Policy.